No Drain Mastectomy Using TissuGlu Surgical Adhesive for Flap Fixation
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No Drain Mastectomy Using TissuGlu® Surgical Adhesive
for Flap Fixation
Christian Eichler1, Faten Dahdouh1, Petra Fischer1, Mathias Warm2
1
Department of Gynecology and Obstetrics, Holweide Hospital, Cologne, Germany.
2
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
1
Department of Gynecology and Obstetrics, Holweide Hospital, Cologne, Germany.
2
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.
INTRODUCTION
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
1Fig. 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
2the 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
3using this technique to reduce the risk of REFERENCES
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5Cohera Medical, Inc. For more information visit us online at: 209 Sandusky Street www.coheramed.de Pittsburgh, PA 15212 USA www.coheramed.com TissuGlu Surgical Adhesive received European CE Mark in 2011. Currently, TissuGlu Surgical Adhesive is approved for investigational use only in the United States and is not approved for sale or marketing in the U.S. or any other country outside of the EU. Cohera Medical, Inc., the Cohera Medical, Inc. logo, and TissuGlu are trademarks of Cohera Medical, Inc. © 2013 Cohera Medical Inc. All rights reserved. MKT-0068 Rev A
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