Alexis - Clinical Evidence

Alexis - Clinical Evidence
Clinical Evidence                                                                                          “In this study the use of barrier wound protection in elective open colorectal resectional surgery
                                                                                                                                         resulted in a clinically significant reduction in incisional surgical site infections.”
         Supporting the use of the Alexis® wound protector/retractor                                                                     ...
                                                                                                                                         “There was a significant reduction in the incidence of incisional surgical site infections when the
“Impervious plastic wound protectors reduce the risk of SSI when employed in                                                             wound protector was used: 3 of 64 (4.7%) vs 15 of 66 (22.7%).”


                                                                                                                                                                                                                                                                           Alexis®
non-trauma-related gastrointestinal and biliary tract surgery. Wound protectors represent                                                Reid K., et al. Barrier Wound Protection Decreases Surgical Site Infection in Open Elective Colorectal Surgery: A Randomized
a safe and simple intervention that may reduce postoperative morbidity and mortality.”                                                   Clinical Trial. Dis Colon Rectum. 2010 Oct; 53(10): 1374-1380.
...
“There was a nonsignificant trend toward greater protective effect in studies using a dual
ring protector (RR = 0.31, 95% Cl 0.14-0.67, P = 0.003), rather than a single ring protector
(RR = 0.83, 95% Cl 0.38-1.83, P = 0.64).”                                                                                                “Our data demonstrate that a statistically significant reduction in the incidence of wound
                                                                                                                                                                                                                                                                           Wound Protectors/Retractors
                                                                                                                                         infection was achieved with the use of a wound-protection device. This device provides a
Edwards J. P., et al. Wound Protectors Reduce Surgical Site Infection: A Meta-Analysis of Randomized Controlled Trials. Ann Surg.
2012 Jul; 256(1): 53-59.                                                                                                                 simple intervention that may eventually have a large impact on the incidence of surgical
                                                                                                                                         wound infection and therefore annual health care expenditures.”
“Superficial incisional SSI was significantly diminished in the ALEXIS wound retractor group                                             Lee P., et al. Use of Wound-Protection System and Postoperative Wound-Infection Rates in Open Appendectomy. Arch Surg. 2009
(P=0.006).”                                                                                                                              Sep; 144(9): 872-875.
...
“The ALEXIS wound retractor is more effective in preventing SSI in elective colorectal
resections compared with conventional methods.”
                                                                                                                                         “The wound infection rate of the [left upper quadrant] trocar site was significantly decreased
Cheng K. P., et al. ALEXIS O-Ring wound retractor vs conventional wound protection for the prevention of surgical site infections        when utilizing the wound retractor (18% to 0%).”
in colorectal resections. Colorectal Dis. 2012 Jun; 14(6): 346-351.
                                                                                                                                         Nunn A., et al. A Novel Approach to Preventing Wound Infections in Laparoscopic Roux-En-Y Gastric Bypass Patients. SAGES Poster
                                                                                                                                         Session 2008.
“[E]nteric organisms were cultured twice as often from the inside surface of the retractor
compared with the outside surface of the retractor (49% vs 26%, respectively; P < 0.0001).”
...
“[U]se of a plastic wound retractor may result in reduced enteric bacterial colonization of the                                          “We found that the wound retractor/protector prevented the incision site from drying,
surgical incision site during gastrointestinal surgery. Reduced colonization of the surgical                                             decreased tissue damage, and facilitated the migration of neutrophils, suggesting a preventive
incision site by enteric bacteria due to the use of a plastic wound retractor should result in a                                         effect of the device with respect to wound infection.”
reduction in SSI following gastrointestinal surgery.”                                                                                    ...
Mohan H. M., et al. Plastic wound retractors as bacteriological barriers in gastrointestinal surgery: a prospective                      “The studied wound retractor/protector effectively protects wound tissue from damage
multi-institutional trial. J Hosp Infect. 2012 Jun; 81(2): 109-113. Epub 2012 May 11.                                                    due to environmental factors experienced during surgery.”
                                                                                                                                         Horiuchi T., et al. A wound retractor/protector can prevent infection by keeping tissue moist and preventing tissue damage at
“Laparoscopic colon and rectal resection using a clean and dirty technique, with sterile                                                 incision sites. Helix Review Series: Infectious Diseases. 2007; 3: 17-23.
specimen extraction, re-gowning procedure and wound protection have proven to reduce the
incidence of wound infections, for an overall SSI rate of 5.1% compared to previously reported
rates of up to 30%.”
                                                                                                                                         “The results of this study demonstrate that wound infection decreased significantly in the
Nassif G., et al. Wound Infection After Colorectal Surgery In The Laparoscopic Era. SAGES Poster Session 2012.
                                                                                                                                         With Alexis retractor group.”
                                                                                                                                         ...
“Only the use of a wound protector was found to significantly reduce the risk of wound                                                   “It was suggested that the use of the Alexis wound retractor would protect surgical wounds
infections in an adjusted analysis.”                                                                                                     from contamination by bacteria and thus prevent infection.”
Lee K.-W., et al. Use of an Upper Midline Incision for Living Donor Partial Hepatectomy: A Series of 143 Consecutive Cases. Liver        Horiuchi T., et al. Randomized Controlled Investigation of the Anti-Infective Properties of the Alexis Retractor/Protector
Transpl. 2011 Aug; 17(8): 969-975.                                                                                                       of Incision Sites. J Trauma. 2007 Jan; 62(1): 212-215.



“These results suggest that the [wound protector] protects an incision site from bacterial
invasion.”
                                                                                                                                                                                                                                                                           360o Wound Protection
...                                                                                                                                                                                                                                                                        360o Atraumatic Retraction
“[W]e consider that the low incidence of SSI may have resulted from the protective effects of the                                                             Visit www.stopwoundinfection.com
                                                                                                                                                                                                                                                                           •   Maximizes exposure, minimizes incision size
[wound protector].”                                                                                                                                           to learn more about
                                                                                                                                                              surgical site infection prevention.                                                                          •   Offers ultimate versatility
Horiuchi T., et al. A Wound Protector Shields Incision Sites from Bacterial Invasion. Surg Infect (Larchmt). 2010 Dec; 11(6): 501-503.
Epub 2010 Sep.
IS ALEXIS® PART OF YOUR                                      BRAND
                                                                                                                                                                                                                                                                                                       Alexis® O Wound Protector/Retractor
                                                                                                                                                                                                                                                                                                           REORDER NO.                            SIZE                                            QUANTITY

STANDARD OF CARE?                                                                                                                                                                                                                                                                                       Featuring a rigid retraction ring for superior exposure

                                                                                                                                                                                                                                                                                                           C8401
                                                                                                                                                                                                                                                                                                           C8402
                                                                                                                                                                                                                                                                                                                                                  Small, 2.5 - 6cm
                                                                                                                                                                                                                                                                                                                                                  Medium, 5 - 9cm
                                                                                                                                                                                                                                                                                                                                                                                                   5/BOX
                                                                                                                                                                                                                                                                                                                                                                                                   5/BOX
                                                                                                                                                                                                                                                                                                           C8403                                  Large, 9 - 14cm                                  5/BOX
                                                                                                                                                                                                                                                                                                           C8404                                  X-Large, 11 - 17cm                               5/BOX
                                                                                                                                                                                                                                                                                                           C8405                                  XX-Large, 17 - 25cm                              5/BOX


                                    Rate of Superficial Incisional SSI                                                                                                                           Procedural Applications                                                                               Alexis Wound Protector/Retractor
                                                                                                                                                                                                                                                                                                           REORDER NO.                            SIZE                                            QUANTITY
                                                                                                                         Alexis Wound Protector/Retractor                                                       GENERAL                                                                                 Featuring a flexible retraction ring for maximum comformity
                   22.7%                                                                                                                                                                                                                                                                                   C8313                                                                                   5/BOX
                     (15/66)                                                                                             Standard Retractors                                                                    Inguinal Hernia Repair (XS, S)              Splenectomy (L, XL)                                                                   XX-Small, 1 - 3cm
                                                                                                                                                                                                                Thyroidectomy (XS, S)                       Pancreatectomy (L, XL)                         C8323                                  XX-Small, Short, 1 - 3cm                         5/BOX
                                                                                                                                                                                                                Appendectomy (S, M)                         Whipple (XXL)                                  C8312                                  X-Small, 2 - 4cm                                 5/BOX
                                                                                                                                                                                                                                                                                                           C8322                                  X-Small, Short, 2 - 4cm                          5/BOX
                                                                                                                                                                                                                                                                                                           C8301                                  Small, 2.5 - 6cm                                 5/BOX
                                           P = 0.004                    14.6%                                                                                                                                                  BREAST                                                                      C8302                                  Medium, 5 - 9cm                                  5/BOX
                                                                          (7/48)                 P = 0.02                                                                                                                                                                                                  C8303                                  Large, 9 - 14cm                                  5/BOX
                                                                                                                                                                                                                               Lumpectomy (XS, S)
                                                                                                                                                    P = 0.0021                                                                                                                                             C8304                                  X-Large, 11 - 17cm                               5/BOX
                                             79%                                                                                                                                                                               Mastectomy (S, M)
                                              RRR*                                                89%                                                                                                                          Sentinel Lymph Node Biopsy (XXS, XS, S)
                                                                                                   RRR*                                               100%
                                                                                                                              8.1%                      RRR*                                                                                                                                           Alexis Laparoscopic System with Kii® Fios® First Entry
                                                                                                                              (9/110)
                                                                                                1.6%                                                                                                            OB/GYN                                                                                     REORDER NO.                            SIZE                                            QUANTITY
                                          4.69%                                                  (1/61)                                                 0%
                                             (3/64)                                                                                                   (0/111)                                                   Postpartum Tubal Ligation (XXS, XS)         Myomectomy (S, M)                              C8701                                  Small, 2.5 - 6cm                                 5/BOX
                                                                                                                                                                                                                Bilateral Salpingo Oophorectomy (XS, S)     Total Abdominal Hysterectomy (S, M, L)         C8702                                  Medium, 5 - 9cm                                  5/BOX
                       Reid, et al. 1                                          Lee, et al. 2                                  Horiuchi, et al. 3                                                                Lap Hysterectomy (S, M Laparoscopic System) Cesarean Section (L, XL)
                                                                                                                                                                                                                Mini-Laparotomy (S, M)

1. Reid K., et al. Barrier Wound Protection Decreases Surgical Site Infection in Open Elective Colorectal Surgery: A Randomized Clinical Trial. Dis Colon Rectum. 2010 Oct; 53(10): 1374-1380.
2. Lee P., et al. Use of Wound-Protection System and Postoperative Wound-Infection Rates in Open Appendectomy. Arch Surg. 2009 Sep; 144(9): 872-875.
3. Horiuchi T., et al. Randomized Controlled Investigation of the Anti-Infective Properties of the Alexis Retractor/Protector of Incision Sites. J Trauma. 2007 Jan; 62(1): 212-215.
                                                                                                                                                                                                                               BARIATRIC
*RRR (relative risk reduction) was defined as the proportion of the control group (standard retractors) experiencing a given outcome minus the proportion of the treatment group
(Alexis protector) experiencing the outcome, divided by the proportion of the control group (standard retractors) experiencing the outcome.
                                                                                                                                                                                                                               Lap Sleeve Gastrectomy (XXS)
                                                                                                                                                                                                                                                                                                       Alexis O C-Section Retractor
                                                                                                                                                                                                                               Lap Gastric Bypass (XS, S)                                                  REORDER NO.                            SIZE                                            QUANTITY
                                                                                                                                                                                                                               Open Gastric Bypass (L, XL)
Provides 360o Protection                                                                                                                                                                                                                                                                                   G6313                                  Large, 9 - 14cm                                  5/BOX
                                                                                                                                                                                                                                                                                                           G6314                                  X-Large, 11 - 17cm                               5/BOX
· Maintains moisture at the incision site                                                                                                                                                                       COLON & RECTAL
· Allows visualization of wound margins                                                                                                                                                                         Stoma Formation (XXS)
                                                                                                                                                                                                                Lap Colectomy (S, M Laparoscopic System)
                                                                                                                                                                                                                Open Colectomy (L, XL, XXL)
Provides 360o Atraumatic Circumferential Retraction
                                                                                                                                                                                                                                                                                                        Alexis Orthopaedic Protector
· Distributes force evenly for optimal field of view                                                                                                                                                                 CARDIOTHORACIC
                                                                                                                                                                                                                                                                                                           REORDER NO.                             SIZE                                           QUANTITY
                                                                                                                                                                                                                     Video-Assisted Thoracoscopic Surgery (VATS) (XXS, XS, S)
· Allows for maximum exposure with a minimum incision size                                                                                                                                                           Mitral Valve Repair/Replacement (S, M)
                                                                                                                                                                                                                                                                                                           HR001                                  Small/Small, 2.5 - 8cm                           5/BOX
                                                                                                                                                                                                                                                                                                           HR004                                  Small/Medium, 2.5 - 8cm                          5/BOX
                                                                                                                                                                                                                     Thoracotomy (S, M)
· Provides unparalleled exposure without trauma associated with prolonged                                                                                                                                                                                                                                  HR005                                  Medium/Large, 5 - 13cm                           5/BOX
  point retraction
                                                                                                                                                                                                                ORTHOPAEDIC                                                                                                         http://contact.appliedmedical.com/

Offers Ultimate Versatility                                                                                                                                                                                     Total Shoulder Arthroplasty (S/S)
                                                                                                                                                                                                                Total Hip Arthroplasty (S/M, M/L)
                                                                                                                                                                                                                                                                                                                                   For more information
                                                                                                                                                                                                                                                                                                                                   www.appliedmedical.com/alexis
· Multiple sizes accommodate a wide range of surgeries
                                                                                                                                                                                                                                                                                                     © 2015 Applied Medical Resources Corporation. All rights reserved.

· Unique design facilitates rapid and effortless setup                                                                                                                                                                                                                                               Applied Medical, the Applied Medical logo design and marks designated with a ® are trademarks of Applied Medical Resources Corporation,
                                                                                                                                                                                                                                                                                                     registered in one or more of the following countries: Australia, Canada, Japan, the United States and/or the European Union. SC01531K
IS ALEXIS® PART OF YOUR                                      BRAND
                                                                                                                                                                                                                                                                                                       Alexis® O Wound Protector/Retractor
                                                                                                                                                                                                                                                                                                           REORDER NO.                            SIZE                                            QUANTITY

STANDARD OF CARE?                                                                                                                                                                                                                                                                                       Featuring a rigid retraction ring for superior exposure

                                                                                                                                                                                                                                                                                                           C8401
                                                                                                                                                                                                                                                                                                           C8402
                                                                                                                                                                                                                                                                                                                                                  Small, 2.5 - 6cm
                                                                                                                                                                                                                                                                                                                                                  Medium, 5 - 9cm
                                                                                                                                                                                                                                                                                                                                                                                                   5/BOX
                                                                                                                                                                                                                                                                                                                                                                                                   5/BOX
                                                                                                                                                                                                                                                                                                           C8403                                  Large, 9 - 14cm                                  5/BOX
                                                                                                                                                                                                                                                                                                           C8404                                  X-Large, 11 - 17cm                               5/BOX
                                                                                                                                                                                                                                                                                                           C8405                                  XX-Large, 17 - 25cm                              5/BOX


                                    Rate of Superficial Incisional SSI                                                                                                                           Procedural Applications                                                                               Alexis Wound Protector/Retractor
                                                                                                                                                                                                                                                                                                           REORDER NO.                            SIZE                                            QUANTITY
                                                                                                                         Alexis Wound Protector/Retractor                                                       GENERAL                                                                                 Featuring a flexible retraction ring for maximum comformity
                   22.7%                                                                                                                                                                                                                                                                                   C8313                                                                                   5/BOX
                     (15/66)                                                                                             Standard Retractors                                                                    Inguinal Hernia Repair (XS, S)              Splenectomy (L, XL)                                                                   XX-Small, 1 - 3cm
                                                                                                                                                                                                                Thyroidectomy (XS, S)                       Pancreatectomy (L, XL)                         C8323                                  XX-Small, Short, 1 - 3cm                         5/BOX
                                                                                                                                                                                                                Appendectomy (S, M)                         Whipple (XXL)                                  C8312                                  X-Small, 2 - 4cm                                 5/BOX
                                                                                                                                                                                                                                                                                                           C8322                                  X-Small, Short, 2 - 4cm                          5/BOX
                                                                                                                                                                                                                                                                                                           C8301                                  Small, 2.5 - 6cm                                 5/BOX
                                           P = 0.004                    14.6%                                                                                                                                                  BREAST                                                                      C8302                                  Medium, 5 - 9cm                                  5/BOX
                                                                          (7/48)                 P = 0.02                                                                                                                                                                                                  C8303                                  Large, 9 - 14cm                                  5/BOX
                                                                                                                                                                                                                               Lumpectomy (XS, S)
                                                                                                                                                    P = 0.0021                                                                                                                                             C8304                                  X-Large, 11 - 17cm                               5/BOX
                                             79%                                                                                                                                                                               Mastectomy (S, M)
                                              RRR*                                                89%                                                                                                                          Sentinel Lymph Node Biopsy (XXS, XS, S)
                                                                                                   RRR*                                               100%
                                                                                                                              8.1%                      RRR*                                                                                                                                           Alexis Laparoscopic System with Kii® Fios® First Entry
                                                                                                                              (9/110)
                                                                                                1.6%                                                                                                            OB/GYN                                                                                     REORDER NO.                            SIZE                                            QUANTITY
                                          4.69%                                                  (1/61)                                                 0%
                                             (3/64)                                                                                                   (0/111)                                                   Postpartum Tubal Ligation (XXS, XS)         Myomectomy (S, M)                              C8701                                  Small, 2.5 - 6cm                                 5/BOX
                                                                                                                                                                                                                Bilateral Salpingo Oophorectomy (XS, S)     Total Abdominal Hysterectomy (S, M, L)         C8702                                  Medium, 5 - 9cm                                  5/BOX
                       Reid, et al. 1                                          Lee, et al. 2                                  Horiuchi, et al. 3                                                                Lap Hysterectomy (S, M Laparoscopic System) Cesarean Section (L, XL)
                                                                                                                                                                                                                Mini-Laparotomy (S, M)

1. Reid K., et al. Barrier Wound Protection Decreases Surgical Site Infection in Open Elective Colorectal Surgery: A Randomized Clinical Trial. Dis Colon Rectum. 2010 Oct; 53(10): 1374-1380.
2. Lee P., et al. Use of Wound-Protection System and Postoperative Wound-Infection Rates in Open Appendectomy. Arch Surg. 2009 Sep; 144(9): 872-875.
3. Horiuchi T., et al. Randomized Controlled Investigation of the Anti-Infective Properties of the Alexis Retractor/Protector of Incision Sites. J Trauma. 2007 Jan; 62(1): 212-215.
                                                                                                                                                                                                                               BARIATRIC
*RRR (relative risk reduction) was defined as the proportion of the control group (standard retractors) experiencing a given outcome minus the proportion of the treatment group
(Alexis protector) experiencing the outcome, divided by the proportion of the control group (standard retractors) experiencing the outcome.
                                                                                                                                                                                                                               Lap Sleeve Gastrectomy (XXS)
                                                                                                                                                                                                                                                                                                       Alexis O C-Section Retractor
                                                                                                                                                                                                                               Lap Gastric Bypass (XS, S)                                                  REORDER NO.                            SIZE                                            QUANTITY
                                                                                                                                                                                                                               Open Gastric Bypass (L, XL)
Provides 360o Protection                                                                                                                                                                                                                                                                                   G6313                                  Large, 9 - 14cm                                  5/BOX
                                                                                                                                                                                                                                                                                                           G6314                                  X-Large, 11 - 17cm                               5/BOX
· Maintains moisture at the incision site                                                                                                                                                                       COLON & RECTAL
· Allows visualization of wound margins                                                                                                                                                                         Stoma Formation (XXS)
                                                                                                                                                                                                                Lap Colectomy (S, M Laparoscopic System)
                                                                                                                                                                                                                Open Colectomy (L, XL, XXL)
Provides 360o Atraumatic Circumferential Retraction
                                                                                                                                                                                                                                                                                                        Alexis Orthopaedic Protector
· Distributes force evenly for optimal field of view                                                                                                                                                                 CARDIOTHORACIC
                                                                                                                                                                                                                                                                                                           REORDER NO.                             SIZE                                           QUANTITY
                                                                                                                                                                                                                     Video-Assisted Thoracoscopic Surgery (VATS) (XXS, XS, S)
· Allows for maximum exposure with a minimum incision size                                                                                                                                                           Mitral Valve Repair/Replacement (S, M)
                                                                                                                                                                                                                                                                                                           HR001                                  Small/Small, 2.5 - 8cm                           5/BOX
                                                                                                                                                                                                                                                                                                           HR004                                  Small/Medium, 2.5 - 8cm                          5/BOX
                                                                                                                                                                                                                     Thoracotomy (S, M)
· Provides unparalleled exposure without trauma associated with prolonged                                                                                                                                                                                                                                  HR005                                  Medium/Large, 5 - 13cm                           5/BOX
  point retraction
                                                                                                                                                                                                                ORTHOPAEDIC                                                                                                         http://contact.appliedmedical.com/

Offers Ultimate Versatility                                                                                                                                                                                     Total Shoulder Arthroplasty (S/S)
                                                                                                                                                                                                                Total Hip Arthroplasty (S/M, M/L)
                                                                                                                                                                                                                                                                                                                                   For more information
                                                                                                                                                                                                                                                                                                                                   www.appliedmedical.com/alexis
· Multiple sizes accommodate a wide range of surgeries
                                                                                                                                                                                                                                                                                                     © 2015 Applied Medical Resources Corporation. All rights reserved.

· Unique design facilitates rapid and effortless setup                                                                                                                                                                                                                                               Applied Medical, the Applied Medical logo design and marks designated with a ® are trademarks of Applied Medical Resources Corporation,
                                                                                                                                                                                                                                                                                                     registered in one or more of the following countries: Australia, Canada, Japan, the United States and/or the European Union. SC01531K
IS ALEXIS® PART OF YOUR                                      BRAND
                                                                                                                                                                                                                                                                                                       Alexis® O Wound Protector/Retractor
                                                                                                                                                                                                                                                                                                           REORDER NO.                            SIZE                                            QUANTITY

STANDARD OF CARE?                                                                                                                                                                                                                                                                                       Featuring a rigid retraction ring for superior exposure

                                                                                                                                                                                                                                                                                                           C8401
                                                                                                                                                                                                                                                                                                           C8402
                                                                                                                                                                                                                                                                                                                                                  Small, 2.5 - 6cm
                                                                                                                                                                                                                                                                                                                                                  Medium, 5 - 9cm
                                                                                                                                                                                                                                                                                                                                                                                                   5/BOX
                                                                                                                                                                                                                                                                                                                                                                                                   5/BOX
                                                                                                                                                                                                                                                                                                           C8403                                  Large, 9 - 14cm                                  5/BOX
                                                                                                                                                                                                                                                                                                           C8404                                  X-Large, 11 - 17cm                               5/BOX
                                                                                                                                                                                                                                                                                                           C8405                                  XX-Large, 17 - 25cm                              5/BOX


                                    Rate of Superficial Incisional SSI                                                                                                                           Procedural Applications                                                                               Alexis Wound Protector/Retractor
                                                                                                                                                                                                                                                                                                           REORDER NO.                            SIZE                                            QUANTITY
                                                                                                                         Alexis Wound Protector/Retractor                                                       GENERAL                                                                                 Featuring a flexible retraction ring for maximum comformity
                   22.7%                                                                                                                                                                                                                                                                                   C8313                                                                                   5/BOX
                     (15/66)                                                                                             Standard Retractors                                                                    Inguinal Hernia Repair (XS, S)              Splenectomy (L, XL)                                                                   XX-Small, 1 - 3cm
                                                                                                                                                                                                                Thyroidectomy (XS, S)                       Pancreatectomy (L, XL)                         C8323                                  XX-Small, Short, 1 - 3cm                         5/BOX
                                                                                                                                                                                                                Appendectomy (S, M)                         Whipple (XXL)                                  C8312                                  X-Small, 2 - 4cm                                 5/BOX
                                                                                                                                                                                                                                                                                                           C8322                                  X-Small, Short, 2 - 4cm                          5/BOX
                                                                                                                                                                                                                                                                                                           C8301                                  Small, 2.5 - 6cm                                 5/BOX
                                           P = 0.004                    14.6%                                                                                                                                                  BREAST                                                                      C8302                                  Medium, 5 - 9cm                                  5/BOX
                                                                          (7/48)                 P = 0.02                                                                                                                                                                                                  C8303                                  Large, 9 - 14cm                                  5/BOX
                                                                                                                                                                                                                               Lumpectomy (XS, S)
                                                                                                                                                    P = 0.0021                                                                                                                                             C8304                                  X-Large, 11 - 17cm                               5/BOX
                                             79%                                                                                                                                                                               Mastectomy (S, M)
                                              RRR*                                                89%                                                                                                                          Sentinel Lymph Node Biopsy (XXS, XS, S)
                                                                                                   RRR*                                               100%
                                                                                                                              8.1%                      RRR*                                                                                                                                           Alexis Laparoscopic System with Kii® Fios® First Entry
                                                                                                                              (9/110)
                                                                                                1.6%                                                                                                            OB/GYN                                                                                     REORDER NO.                            SIZE                                            QUANTITY
                                          4.69%                                                  (1/61)                                                 0%
                                             (3/64)                                                                                                   (0/111)                                                   Postpartum Tubal Ligation (XXS, XS)         Myomectomy (S, M)                              C8701                                  Small, 2.5 - 6cm                                 5/BOX
                                                                                                                                                                                                                Bilateral Salpingo Oophorectomy (XS, S)     Total Abdominal Hysterectomy (S, M, L)         C8702                                  Medium, 5 - 9cm                                  5/BOX
                       Reid, et al. 1                                          Lee, et al. 2                                  Horiuchi, et al. 3                                                                Lap Hysterectomy (S, M Laparoscopic System) Cesarean Section (L, XL)
                                                                                                                                                                                                                Mini-Laparotomy (S, M)

1. Reid K., et al. Barrier Wound Protection Decreases Surgical Site Infection in Open Elective Colorectal Surgery: A Randomized Clinical Trial. Dis Colon Rectum. 2010 Oct; 53(10): 1374-1380.
2. Lee P., et al. Use of Wound-Protection System and Postoperative Wound-Infection Rates in Open Appendectomy. Arch Surg. 2009 Sep; 144(9): 872-875.
3. Horiuchi T., et al. Randomized Controlled Investigation of the Anti-Infective Properties of the Alexis Retractor/Protector of Incision Sites. J Trauma. 2007 Jan; 62(1): 212-215.
                                                                                                                                                                                                                               BARIATRIC
*RRR (relative risk reduction) was defined as the proportion of the control group (standard retractors) experiencing a given outcome minus the proportion of the treatment group
(Alexis protector) experiencing the outcome, divided by the proportion of the control group (standard retractors) experiencing the outcome.
                                                                                                                                                                                                                               Lap Sleeve Gastrectomy (XXS)
                                                                                                                                                                                                                                                                                                       Alexis O C-Section Retractor
                                                                                                                                                                                                                               Lap Gastric Bypass (XS, S)                                                  REORDER NO.                            SIZE                                            QUANTITY
                                                                                                                                                                                                                               Open Gastric Bypass (L, XL)
Provides 360o Protection                                                                                                                                                                                                                                                                                   G6313                                  Large, 9 - 14cm                                  5/BOX
                                                                                                                                                                                                                                                                                                           G6314                                  X-Large, 11 - 17cm                               5/BOX
· Maintains moisture at the incision site                                                                                                                                                                       COLON & RECTAL
· Allows visualization of wound margins                                                                                                                                                                         Stoma Formation (XXS)
                                                                                                                                                                                                                Lap Colectomy (S, M Laparoscopic System)
                                                                                                                                                                                                                Open Colectomy (L, XL, XXL)
Provides 360o Atraumatic Circumferential Retraction
                                                                                                                                                                                                                                                                                                        Alexis Orthopaedic Protector
· Distributes force evenly for optimal field of view                                                                                                                                                                 CARDIOTHORACIC
                                                                                                                                                                                                                                                                                                           REORDER NO.                             SIZE                                           QUANTITY
                                                                                                                                                                                                                     Video-Assisted Thoracoscopic Surgery (VATS) (XXS, XS, S)
· Allows for maximum exposure with a minimum incision size                                                                                                                                                           Mitral Valve Repair/Replacement (S, M)
                                                                                                                                                                                                                                                                                                           HR001                                  Small/Small, 2.5 - 8cm                           5/BOX
                                                                                                                                                                                                                                                                                                           HR004                                  Small/Medium, 2.5 - 8cm                          5/BOX
                                                                                                                                                                                                                     Thoracotomy (S, M)
· Provides unparalleled exposure without trauma associated with prolonged                                                                                                                                                                                                                                  HR005                                  Medium/Large, 5 - 13cm                           5/BOX
  point retraction
                                                                                                                                                                                                                ORTHOPAEDIC                                                                                                         http://contact.appliedmedical.com/

Offers Ultimate Versatility                                                                                                                                                                                     Total Shoulder Arthroplasty (S/S)
                                                                                                                                                                                                                Total Hip Arthroplasty (S/M, M/L)
                                                                                                                                                                                                                                                                                                                                   For more information
                                                                                                                                                                                                                                                                                                                                   www.appliedmedical.com/alexis
· Multiple sizes accommodate a wide range of surgeries
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· Unique design facilitates rapid and effortless setup                                                                                                                                                                                                                                               Applied Medical, the Applied Medical logo design and marks designated with a ® are trademarks of Applied Medical Resources Corporation,
                                                                                                                                                                                                                                                                                                     registered in one or more of the following countries: Australia, Canada, Japan, the United States and/or the European Union. SC01531K
Clinical Evidence                                                                                          “In this study the use of barrier wound protection in elective open colorectal resectional surgery
                                                                                                                                         resulted in a clinically significant reduction in incisional surgical site infections.”
         Supporting the use of the Alexis® wound protector/retractor                                                                     ...
                                                                                                                                         “There was a significant reduction in the incidence of incisional surgical site infections when the
“Impervious plastic wound protectors reduce the risk of SSI when employed in                                                             wound protector was used: 3 of 64 (4.7%) vs 15 of 66 (22.7%).”


                                                                                                                                                                                                                                                                           Alexis®
non-trauma-related gastrointestinal and biliary tract surgery. Wound protectors represent                                                Reid K., et al. Barrier Wound Protection Decreases Surgical Site Infection in Open Elective Colorectal Surgery: A Randomized
a safe and simple intervention that may reduce postoperative morbidity and mortality.”                                                   Clinical Trial. Dis Colon Rectum. 2010 Oct; 53(10): 1374-1380.
...
“There was a nonsignificant trend toward greater protective effect in studies using a dual
ring protector (RR = 0.31, 95% Cl 0.14-0.67, P = 0.003), rather than a single ring protector
(RR = 0.83, 95% Cl 0.38-1.83, P = 0.64).”                                                                                                “Our data demonstrate that a statistically significant reduction in the incidence of wound
                                                                                                                                                                                                                                                                           Wound Protectors/Retractors
                                                                                                                                         infection was achieved with the use of a wound-protection device. This device provides a
Edwards J. P., et al. Wound Protectors Reduce Surgical Site Infection: A Meta-Analysis of Randomized Controlled Trials. Ann Surg.
2012 Jul; 256(1): 53-59.                                                                                                                 simple intervention that may eventually have a large impact on the incidence of surgical
                                                                                                                                         wound infection and therefore annual health care expenditures.”
“Superficial incisional SSI was significantly diminished in the ALEXIS wound retractor group                                             Lee P., et al. Use of Wound-Protection System and Postoperative Wound-Infection Rates in Open Appendectomy. Arch Surg. 2009
(P=0.006).”                                                                                                                              Sep; 144(9): 872-875.
...
“The ALEXIS wound retractor is more effective in preventing SSI in elective colorectal
resections compared with conventional methods.”
                                                                                                                                         “The wound infection rate of the [left upper quadrant] trocar site was significantly decreased
Cheng K. P., et al. ALEXIS O-Ring wound retractor vs conventional wound protection for the prevention of surgical site infections        when utilizing the wound retractor (18% to 0%).”
in colorectal resections. Colorectal Dis. 2012 Jun; 14(6): 346-351.
                                                                                                                                         Nunn A., et al. A Novel Approach to Preventing Wound Infections in Laparoscopic Roux-En-Y Gastric Bypass Patients. SAGES Poster
                                                                                                                                         Session 2008.
“[E]nteric organisms were cultured twice as often from the inside surface of the retractor
compared with the outside surface of the retractor (49% vs 26%, respectively; P < 0.0001).”
...
“[U]se of a plastic wound retractor may result in reduced enteric bacterial colonization of the                                          “We found that the wound retractor/protector prevented the incision site from drying,
surgical incision site during gastrointestinal surgery. Reduced colonization of the surgical                                             decreased tissue damage, and facilitated the migration of neutrophils, suggesting a preventive
incision site by enteric bacteria due to the use of a plastic wound retractor should result in a                                         effect of the device with respect to wound infection.”
reduction in SSI following gastrointestinal surgery.”                                                                                    ...
Mohan H. M., et al. Plastic wound retractors as bacteriological barriers in gastrointestinal surgery: a prospective                      “The studied wound retractor/protector effectively protects wound tissue from damage
multi-institutional trial. J Hosp Infect. 2012 Jun; 81(2): 109-113. Epub 2012 May 11.                                                    due to environmental factors experienced during surgery.”
                                                                                                                                         Horiuchi T., et al. A wound retractor/protector can prevent infection by keeping tissue moist and preventing tissue damage at
“Laparoscopic colon and rectal resection using a clean and dirty technique, with sterile                                                 incision sites. Helix Review Series: Infectious Diseases. 2007; 3: 17-23.
specimen extraction, re-gowning procedure and wound protection have proven to reduce the
incidence of wound infections, for an overall SSI rate of 5.1% compared to previously reported
rates of up to 30%.”
                                                                                                                                         “The results of this study demonstrate that wound infection decreased significantly in the
Nassif G., et al. Wound Infection After Colorectal Surgery In The Laparoscopic Era. SAGES Poster Session 2012.
                                                                                                                                         With Alexis retractor group.”
                                                                                                                                         ...
“Only the use of a wound protector was found to significantly reduce the risk of wound                                                   “It was suggested that the use of the Alexis wound retractor would protect surgical wounds
infections in an adjusted analysis.”                                                                                                     from contamination by bacteria and thus prevent infection.”
Lee K.-W., et al. Use of an Upper Midline Incision for Living Donor Partial Hepatectomy: A Series of 143 Consecutive Cases. Liver        Horiuchi T., et al. Randomized Controlled Investigation of the Anti-Infective Properties of the Alexis Retractor/Protector
Transpl. 2011 Aug; 17(8): 969-975.                                                                                                       of Incision Sites. J Trauma. 2007 Jan; 62(1): 212-215.



“These results suggest that the [wound protector] protects an incision site from bacterial
invasion.”
                                                                                                                                                                                                                                                                           360o Wound Protection
...                                                                                                                                                                                                                                                                        360o Atraumatic Retraction
“[W]e consider that the low incidence of SSI may have resulted from the protective effects of the                                                             Visit www.stopwoundinfection.com
                                                                                                                                                                                                                                                                           •   Maximizes exposure, minimizes incision size
[wound protector].”                                                                                                                                           to learn more about
                                                                                                                                                              surgical site infection prevention.                                                                          •   Offers ultimate versatility
Horiuchi T., et al. A Wound Protector Shields Incision Sites from Bacterial Invasion. Surg Infect (Larchmt). 2010 Dec; 11(6): 501-503.
Epub 2010 Sep.
Clinical Evidence                                                                                          “In this study the use of barrier wound protection in elective open colorectal resectional surgery
                                                                                                                                         resulted in a clinically significant reduction in incisional surgical site infections.”
         Supporting the use of the Alexis® wound protector/retractor                                                                     ...
                                                                                                                                         “There was a significant reduction in the incidence of incisional surgical site infections when the
“Impervious plastic wound protectors reduce the risk of SSI when employed in                                                             wound protector was used: 3 of 64 (4.7%) vs 15 of 66 (22.7%).”


                                                                                                                                                                                                                                                                           Alexis®
non-trauma-related gastrointestinal and biliary tract surgery. Wound protectors represent                                                Reid K., et al. Barrier Wound Protection Decreases Surgical Site Infection in Open Elective Colorectal Surgery: A Randomized
a safe and simple intervention that may reduce postoperative morbidity and mortality.”                                                   Clinical Trial. Dis Colon Rectum. 2010 Oct; 53(10): 1374-1380.
...
“There was a nonsignificant trend toward greater protective effect in studies using a dual
ring protector (RR = 0.31, 95% Cl 0.14-0.67, P = 0.003), rather than a single ring protector
(RR = 0.83, 95% Cl 0.38-1.83, P = 0.64).”                                                                                                “Our data demonstrate that a statistically significant reduction in the incidence of wound
                                                                                                                                                                                                                                                                           Wound Protectors/Retractors
                                                                                                                                         infection was achieved with the use of a wound-protection device. This device provides a
Edwards J. P., et al. Wound Protectors Reduce Surgical Site Infection: A Meta-Analysis of Randomized Controlled Trials. Ann Surg.
2012 Jul; 256(1): 53-59.                                                                                                                 simple intervention that may eventually have a large impact on the incidence of surgical
                                                                                                                                         wound infection and therefore annual health care expenditures.”
“Superficial incisional SSI was significantly diminished in the ALEXIS wound retractor group                                             Lee P., et al. Use of Wound-Protection System and Postoperative Wound-Infection Rates in Open Appendectomy. Arch Surg. 2009
(P=0.006).”                                                                                                                              Sep; 144(9): 872-875.
...
“The ALEXIS wound retractor is more effective in preventing SSI in elective colorectal
resections compared with conventional methods.”
                                                                                                                                         “The wound infection rate of the [left upper quadrant] trocar site was significantly decreased
Cheng K. P., et al. ALEXIS O-Ring wound retractor vs conventional wound protection for the prevention of surgical site infections        when utilizing the wound retractor (18% to 0%).”
in colorectal resections. Colorectal Dis. 2012 Jun; 14(6): 346-351.
                                                                                                                                         Nunn A., et al. A Novel Approach to Preventing Wound Infections in Laparoscopic Roux-En-Y Gastric Bypass Patients. SAGES Poster
                                                                                                                                         Session 2008.
“[E]nteric organisms were cultured twice as often from the inside surface of the retractor
compared with the outside surface of the retractor (49% vs 26%, respectively; P < 0.0001).”
...
“[U]se of a plastic wound retractor may result in reduced enteric bacterial colonization of the                                          “We found that the wound retractor/protector prevented the incision site from drying,
surgical incision site during gastrointestinal surgery. Reduced colonization of the surgical                                             decreased tissue damage, and facilitated the migration of neutrophils, suggesting a preventive
incision site by enteric bacteria due to the use of a plastic wound retractor should result in a                                         effect of the device with respect to wound infection.”
reduction in SSI following gastrointestinal surgery.”                                                                                    ...
Mohan H. M., et al. Plastic wound retractors as bacteriological barriers in gastrointestinal surgery: a prospective                      “The studied wound retractor/protector effectively protects wound tissue from damage
multi-institutional trial. J Hosp Infect. 2012 Jun; 81(2): 109-113. Epub 2012 May 11.                                                    due to environmental factors experienced during surgery.”
                                                                                                                                         Horiuchi T., et al. A wound retractor/protector can prevent infection by keeping tissue moist and preventing tissue damage at
“Laparoscopic colon and rectal resection using a clean and dirty technique, with sterile                                                 incision sites. Helix Review Series: Infectious Diseases. 2007; 3: 17-23.
specimen extraction, re-gowning procedure and wound protection have proven to reduce the
incidence of wound infections, for an overall SSI rate of 5.1% compared to previously reported
rates of up to 30%.”
                                                                                                                                         “The results of this study demonstrate that wound infection decreased significantly in the
Nassif G., et al. Wound Infection After Colorectal Surgery In The Laparoscopic Era. SAGES Poster Session 2012.
                                                                                                                                         With Alexis retractor group.”
                                                                                                                                         ...
“Only the use of a wound protector was found to significantly reduce the risk of wound                                                   “It was suggested that the use of the Alexis wound retractor would protect surgical wounds
infections in an adjusted analysis.”                                                                                                     from contamination by bacteria and thus prevent infection.”
Lee K.-W., et al. Use of an Upper Midline Incision for Living Donor Partial Hepatectomy: A Series of 143 Consecutive Cases. Liver        Horiuchi T., et al. Randomized Controlled Investigation of the Anti-Infective Properties of the Alexis Retractor/Protector
Transpl. 2011 Aug; 17(8): 969-975.                                                                                                       of Incision Sites. J Trauma. 2007 Jan; 62(1): 212-215.



“These results suggest that the [wound protector] protects an incision site from bacterial
invasion.”
                                                                                                                                                                                                                                                                           360o Wound Protection
...                                                                                                                                                                                                                                                                        360o Atraumatic Retraction
“[W]e consider that the low incidence of SSI may have resulted from the protective effects of the                                                             Visit www.stopwoundinfection.com
                                                                                                                                                                                                                                                                           •   Maximizes exposure, minimizes incision size
[wound protector].”                                                                                                                                           to learn more about
                                                                                                                                                              surgical site infection prevention.                                                                          •   Offers ultimate versatility
Horiuchi T., et al. A Wound Protector Shields Incision Sites from Bacterial Invasion. Surg Infect (Larchmt). 2010 Dec; 11(6): 501-503.
Epub 2010 Sep.
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