No Drain Mastectomy Using TissuGlu Surgical Adhesive for Flap Fixation

No Drain Mastectomy Using TissuGlu® Surgical Adhesive
                      for Flap Fixation
      Christian Eichler1, Faten Dahdouh1, Petra Fischer1, Mathias Warm2
    Department of Gynecology and Obstetrics, Holweide Hospital, Cologne, Germany.
             Department of Health, University of Witten/Herdecke, Germany.
No Drain Mastectomy Using TissuGlu® Surgical Adhesive
                           for Flap Fixation
Christian Eichler1, Faten Dahdouh1, Petra Fischer1, Mathias Warm2
    Department of Gynecology and Obstetrics, Holweide Hospital, Cologne, Germany.
    Department of Health, University of Witten/Herdecke, Germany.

Abstract: Post mastectomy seroma is a frequent complication in oncological surgery in breast
cancer patients with a postoperative occurrence of up to 59%. While drain placement is a
common approach used to manage this complication, some patients may either be incapable of or
unwilling to accept the use of drains, thus requiring an alternative option for the management of
fluid accumulation. A recent series performed by our group using, TissuGlu® Surgical Adhesive,
demonstrated promising results following its use in mastectomy patients. We subsequently
utilized TissuGlu in 3 patients in whom drain placement was not considered a viable alternative.
Our standard surgical and postoperative treatment approach was used for each of these patients.
Two of the patients in our series did not experience postoperative seroma formation. The third
patient had minor fluid accumulation requiring aspiration at two weeks (180 ml) and four weeks
(60 ml) post-surgery. No additional complications or adverse events, such as hematoma or wound
dehiscence, were observed. Patient satisfaction with our no drain approach using TissuGlu was
high as a result of the elimination of post-surgical drain use and associated discomfort. TissuGlu
Surgical Adhesive offers an effective new option allowing for no drain mastectomy procedures.

Post mastectomy seroma formation in breast           seroma formation described in literature such
cancer patients is a frequent complication           as previous surgeries, radiation treatment,
following oncological surgery.1,2 The most           chemotherapy, smoking, advanced age and
commonly utilized approach for preventing            obesity are often beyond the control of the
seroma formation in these patients is the            operating physicians.4-7
placement of surgical drains within the
                                                     We have begun to evaluate the use of a
wound area. Since some patients are either
                                                     lysine-derived urethane adhesive (TissuGlu,
unable or unwilling to accept the use of
                                                     Cohera Medical, Inc.®, Pittsburgh, PA, USA)
surgical drains, alternative options for
                                                     as an alternative to the use of drains in
preventing or resolving post-operative fluid
                                                     certain patient populations when the use of
accumulation without drains are needed.
                                                     post-surgical drains is not feasible. TissuGlu
Despite the use of post-surgical drains              is a surgical adhesive which adheres the
following mastectomy surgery, up to 59%              flaps of tissue and eliminates the dead space
of patients still experience post-surgical           in the wound area, thereby reducing the risk
seroma formation after drain removal.1               of seroma formation following surgery.7
Given the limited clinical evidence that
                                                     We present below 3 separate cases of breast
drain placement actually reduces seroma
                                                     cancer patients treated with TissuGlu as an
formation, and the associated patient
                                                     alternative to drains following a standard
discomfor t drains may cause, some
                                                     mastectomy procedure. (Fig 1). In each case
physicians believe that drain placement
                                                     the TissuGlu was applied starting with the
may not represent a satisfactory solution
                                                     placement of the first set of drops on the
for seroma prevention and may not offer a
                                                     medial superior corner of the wound surface
clinical benefit.3 While other physicians may
                                                     (Fig 2). Using the TissuGlu Applicator’s
disagree with this conclusion, alternative
                                                     Spacing Guide, continued application of the
options to drains are sometimes required
                                                     adhesive drops proceeded inferiorly until
for patients who are unable or unwilling
                                                     the inferior edge of the wound was reached
to accept the use of post-surgical drains.
                                                     (typically 4 to 6 sets of drops). The pivoting
This is especially true since risk factors for
Fig. 1. T
         he surgical wound prior to application       and had a current BMI of 20, she was
        of TissuGlu                                    considered at fairly low risk for seroma
                                                       formation. The patient indicated prior to the
                                                       procedure that the use of post-surgical drain
                                                       placement was undesirable for her, and as
                                                       a result, a no-drain mastectomy procedure
                                                       of the left breast without axillary dissection
                                                       was performed using TissuGlu to prevent
                                                       postoperative fluid accumulation. The patient
                                                       presented with adequate wound healing
                                                       and with no signs of fluid accumulation or
                                                       seroma formation at both the 2 week and
                                                       4 week post-surgical follow-up visits and
                                                       healed without any complications.
                                                       Patient #2 was a 70-year-old female with
                                                       breast cancer (cT4, N0-2, G3). Due to the
                                                       invasiveness of the cancer, the patient
                                                       underwent a palliative mastectomy of the
head of the TissuGlu applicator was rotated,           right breast with 4 sentinel lymph nodes
as needed, to facilitate access to wound               removed, with dissection to Level II.
surface areas and accurate placement of the            Since the patient has been diagnosed with
adhesive. Drop placement then proceeded                Alzheimer’s and was frequently agitated,
laterally and back to the superior edge of             there were concerns that the patient would
the wound surface ensuring space was left              inadvertently or purposely remove the
between the first and second rows of drops             post-operative drains increasing the risk of
(Fig 3).                                               infection and post-surgical complications.
                                                       As a result, we performed a no drain
It is important to avoid over application of           mastectomy using TissuGlu. As with the
the adhesive and overlapping rows of the               previous case, the patient exhibited adequate
adhesive droplets. If the wound surface area           wound healing with no signs of f luid
extended onto the patient’s side, the table            accumulation or seroma formation at both
was tilted so that the surface area where
                                                       Fig. 2. The TissuGlu® Applicator’s Spacing
the TissuGlu was applied was as close to
                                                               Guide allows for the precise placement
horizontal as possible. After application of
                                                               of the adhesive to the wound surface.
the TissuGlu was completed, the skin flap
was lifted and carefully positioned to avoid
smearing of the adhesive. Light pressure was
then applied to the skin flap prior to closure.
Case Presentations
Patient #1 was a 79-year-old female who
was first diagnosed with breast cancer in
1997 at the age of 64. At that time she had
received breast conserving surgery as
well as an axillary dissection, radiation
therapy and anti-hormone therapy. Standard
mammography screening in 2013 revealed
recurrence of her cancer and a mastectomy
was recommended to the patient due to
a large ductal carcinoma in situ (DCIS)
component as well as patient age and
treatment history. Since the patient had
received no prior chemotherapy and no
radiation treatment within the last 10 years
the 2 week and 4 week follow-up visits and            Fig. 3. TissuGlu drops are applied in a series
healed with an unremarkable course of care.                    of rows across the wound surface to
Patient #3 was a 43-year-old female patient                    ensure adequate flap fixation. Over
who was first diagnosed with breast cancer                     application of the adhesive should be
in 2008 at the age of 38. After sentinel node                  avoided.
biopsy and breast conserving surgery the
same year, no further treatment was allowed
by the patient due to her recently discovered
pregnancy. After delivery, all treatment
was denied again due to a second (twin)
pregnancy within weeks of her first delivery.
The patient reported another palpable
mass in 2011 and declined all treatment
as a result of the need to care for her three
children. After a diagnosis of breast cancer
was confirmed in 2011 (T2, HER+, Ki 67),
the patient continued to decline treatment.
In 2013 the patient decided to undergo a
total mastectomy of her right breast as an
outpatient procedure. As a result of concerns
about continuity of care following the
procedure, we elected to perform a no-drain
mastectomy procedure using TissuGlu. As a
result of postoperative fluid accumulation,
the patient was aspirated at 2 weeks (180             suction drains to be necessary when axillary
ml) and 4 weeks (60 ml) during scheduled              dissection is involved, though the evidence
postsurgical follow-up visits due to patient          supporting this is also inconclusive.14 As a
discomfort. No further aspirations or                 result, it is typically the surgeon’s preference
evidence of seroma formation was recorded             and expertise in interpreting the wound
after the 4 week visit.                               surface prior to wound closure which
Discussion                                            leads to a decision to place a drain and/
                                                      or use additional sutures or other fixation
The use of post-surgical drains to reduce             techniques.
post-mastectomy f luid accumulation and
the risk of seroma formation is based on              Since it is sometimes necessary to find an
empirical evidence alone. Some physicians             alternative to post-surgical drains following
are attempting to identify alternatives to            mastectomy procedures, our three cases
using drains since inflammatory responses,            represent potential scenarios where a no-
often caused by drains themselves, may be             drain approach may be clinically beneficial.
in part responsible for seroma formation.8-10         This includes situations in which the patient
Alternative surgical techniques such as               declines the use of drains, as well as cases
progressive tension or quilting suture                in which patients have an increased risk of
techniques and mastectomy flap fixation               voluntary or involuntary non-compliance
have also shown promise. Since areas that             with recommended care following the
have received many previous surgeries,                placement of post-surgical drains that may
radiation therapy and/or chemotherapy                 negatively affect the course of care. When
rarely benefit by adding additional sutures,          we were presented with these issues, we had
these options are often less feasible in              to consider alternative options to prevent
breast cancer patients. Fibrin based                  post-operative complications, including fluid
sealants have also been tested, although              accumulation and the potential for seroma
convincing evidence of efficacy could not             formation. Our approach for the 3 patients
be produced.11-13 In spite of the issues raised       reported on in this paper was to use TissuGlu
above, many surgeons consider the use of              as an alternative to drains. Our interest in
using this technique to reduce the risk of           REFERENCES
fluid accumulation and seroma formation
was a result of favorable results we had             1.	
                                                        H ensel, J.M., et al., An outcomes
obtained in a previous revision mastectomy              analysis and satisfaction survey of 199
case.                                                   consecutive abdominoplasties. Ann Plast
                                                        Surg, 2001. 46(4): p. 357-63.
As reported above, two of the patients in this       2.	
                                                        B oostrom, S.Y., et al., Incidence of
series had no signs of fluid accumulation               clinically significant seroma after breast
or seroma formation at both the 2 and 4                 and axillary surgery. J Am Coll Surg,
week postsurgical visits. While patient #3              2009. 208(1): p. 148-50.
did present with small amounts of f luid
accumulation suggesting seroma formation,            3.	Puttawibul, P., et al., Mastectomy without
we believe this may have been a result                   drain at pectoral area: a randomized
of excessive movement by the patient                     controlled trial. J Med Assoc Thai, 2003.
immediately after surgery. The fluid was                 86(4): p. 325-31.
painlessly aspirated through the mastectomy          4.	Pollock, H. and T. Pollock, Progressive
scar during regularly scheduled follow-up                tension sutures: a technique to reduce
visits with no further aspiration required               local complications in abdominoplasty.
thereafter. None of the three patients                   Plast Reconstr Surg, 2000. 105(7): p.
experienced hematoma formation, excessive                2583-6; discussion 2587-8.
pain or adverse reaction to the TissuGlu.
                                                     5.	Pollock, T.A. and H. Pollock, No-drain
There were no cases of wound dehiscence or
                                                         abdominoplasty with progressive tension
requirement for revision procedures in any of
                                                         sutures. Clin Plast Surg, 2010. 37(3): p.
these patients. All three patients experienced
a decrease in post-surgical discomfort as a
result of the avoidance of drains and had an         6.	
                                                        S hestak, K.C., Progressive Tension
earlier hospital discharge compared to our              Sutures: A Technique to Reduce Local
typical mastectomy patients since waiting for           Complications in Abdominoplasty. Plast
drain removal prior to hospital discharge was           Reconstr Surg, 2000. 105(7): p. 2587-
not required.                                           2588.
                                                     7.	Walgenbach, K.J., et al., Randomized,
conclusion                                               prospective study of TissuGlu® surgical
                                                         adhesive in the management of wound
This report suggests that the use of                     drainage following abdominoplasty.
TissuGlu Surgical Adhesive may offer                     Aesthetic Plast Surg, 2012. 36(3): p. 491-6.
an effective new option allowing for no
drain mastectomy procedures. While our               8.	
                                                        Y ilmaz, K.B., et al., Comparing
experience is limited and further studies               scalpel, electrocautery and ultrasonic
are required, the favorable outcomes we                 dissector effects: the impact on wound
observed with TissuGlu suggest that this                complications and pro-inf lammatory
adhesive may represent a viable alternative             cytokine levels in wound f luid from
when a no drain mastectomy approach is                  mastectomy patients. J Breast Cancer,
utilized. The use of a no drain approach                2011. 14(1): p. 58-63.
for mastectomy procedures, which is                  9.	Almond, L.M., et al., Flap Anchoring
associated with a reduction in postoperative             Following Primar y Breast Cancer
complications, may enhance patient care by               Surgery Facilitates Early Hospital
decreasing patient discomfort and increasing             Discharge and Reduces Costs. Breast
patient satisfaction while also potentially              Care (Basel), 2010. 5(2): p. 97-101.
allowing for the earlier discharge of patients
                                                     10.	Agrawal, A., A.A. Ayantunde, and K.L.
from hospitals.
                                                         Cheung, Concepts of seroma formation
                                                         and prevention in breast cancer surgery.
                                                         ANZ J Surg, 2006. 76(12): p. 1088-95.
11.	Ulusoy, A.N., et al., Effect of fibrin glue
    on lymphatic drainage and on drain
    removal time after modified radical
    mastectomy: a prospective randomized
    study. Breast J, 2003. 9(5): p. 393-6.
12.	Johnson, L., et al., Influence of fibrin
    glue on seroma formation after breast
    surgery. Am J Surg, 2005. 189(3): p. 319-
13.	Jones, G.G., et al., Surgical tip--a novel
    method of applying fibrin sealant during
    repair of divarication of the recti via an
    abdominoplasty incision. J Plast Reconstr
    Aesthet Surg, 2009. 62(11): p. e457-8.
14.	Kuroi et al., Evidence-based risk factors
    for seroma formation in breast surgery.
    Jpn J Clin Oncol, 2006. 36(4):197-206

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TissuGlu Surgical Adhesive received European CE Mark in 2011. Currently, TissuGlu Surgical Adhesive is approved for investigational use
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