ORIGINAL ARTICLE AESTHETIC

Randomized, Prospective Study of TissuGlu� Surgical Adhesivein the Management of Wound Drainage FollowingAbdominoplasty

Klaus J. Walgenbach • Holger Bannasch •

Stefan Kalthoff • J. Peter Rubin

Received: 17 July 2011 / Accepted: 10 October 2011 / Published online: 29 December 2011

� Springer Science+Business Media, LLC and International Society of Aesthetic Plastic Surgery 2011

Abstract

Background Wound drainage and seroma formation fol-

lowing abdominoplasty remain significant concerns to both

surgeons and patients due to the resulting increased need

for patient follow-up and delays in returning to normal

function. While a number of approaches are used to reduce

wound drainage and seroma formation, there is still no

definitive solution. A promising strategy to reduce these

complications is the development of an effective method

for closing dead space between tissue layers in order to

achieve improved patient outcomes.

Methods We conducted a multicenter, prospective, ran-

domized trial assessing the use of a lysine-derived urethane

adhesive (TissuGlu�, Cohera Medical) in patients under-

going abdominoplasty. Twenty patients were randomized

to a treatment group and a control group, with the adhesive

applied to the abdominal wall prior to closure of the

abdominoplasty flap in the treatment group. Control

patients underwent an identical procedure but without

application of TissuGlu. Outcome measures included time

to drain removal, total wound drainage prior to drain

removal, and surgical complications.

Results The use of TissuGlu was associated with a trend

toward decreased time to drain removal compared to the

control group (2.9 ± 1.4 vs. 3.7 ± 1.5 days; P = 0.13).

Mean total drain volume also tended to be lower in the

treatment versus the control group (208.7 ± 138.2 vs.

303.5 ± 240.8 ml; P = 0.14). There were no differences

in adverse events or complication rates between the two

study groups.

Conclusion The application of TissuGlu in abdomino-

plasty is safe and may decrease wound drainage and the

length of time required for postsurgical drains in abdomi-

noplasty patients.

Keywords Abdominoplasty � Drains � Seroma �Adhesive � TissuGlu�

Abdominoplasty has become an increasingly popular sur-

gical procedure and is performed on a routine basis;

however, there is still a significant risk of postsurgical

complications such as seroma formation, wound dehis-

cence, and hematomas [1, 2]. Seroma formation, the most

common complication associated with abdominoplasty, has

been reported to occur in 16–50% of patients following an

abdominoplasty procedure, with higher rates for obese

patients and those who underwent concomitant liposuction

[1–5]. The development of seromas is also associated

with increased postsurgical interventions. A recent study

reported that up to a third of patients presenting with ser-

oma required surgical excision of the bursal cavity [6].

Another study in massive weight loss patients who

underwent abdominoplasty reported even higher rates of

seroma formation, with surgical intervention required in up

to 42% of patients presenting with seroma [7]. The eco-

nomic impact of managing seroma formation and the

K. J. Walgenbach (&)

Plastic and Aesthetic Surgery, University Hospital Bonn,

Sigmund-Freud-Strasse 25, 53127 Bonn, Germany

e-mail: klaus.walgenbach@ukb.uni-bonn.de

H. Bannasch

Erich-Lexer-Klinik, University Medical Center, Freiburg,

Germany

S. Kalthoff

Rosenpark Klinik, Darmstadt, Germany

J. P. Rubin

University of Pittsburgh, Pittsburgh, PA, USA

123

Aesth Plast Surg (2012) 36:491–496

DOI 10.1007/s00266-011-9844-3

associated delays in return to normal function for the

patient highlight the need for new approaches to minimize

this complication.

Seroma formation after abdominoplasty is believed to

result from the ‘‘dead space’’ created between tissue layers

during surgery, as well as from shearing forces between the

underlying tissue and the abdominal flap after surgery [8].

This shearing force may contribute to the release of

inflammatory mediators which contribute to fluid accumu-

lation. It has long been hypothesized that a reduction of the

dead space between layers should reduce wound drainage

and thereby decreases the incidence of seroma in patients

who had large-flap surgical procedures. A number of

approaches have been explored to reduce wound drainage

and seroma formation in abdominoplasty. These include the

placement of closed suction drains [9], avoidance of elec-

trocautery [10], the use of progressive tension (PTS) or

quilting suture techniques [2, 11, 12], the use of fibrin

sealants [13, 14], pressure dressings, and immobilization of

the patient to reduce postsurgical shearing forces between

abdominal tissue layers [5]. None of these methods, how-

ever, either alone or in combination, has been recognized as

a definitive treatment to reduce wound drainage or seroma

formation associated with abdominoplasty.

Recently, a new lysine-derived urethane adhesive

(TissuGlu�, Cohera Medical, Pittsburgh, PA, USA) has

been developed. Preclinical studies in a canine abdomino-

plasty model demonstrated that this adhesive was very

effective at eliminating seroma formation based on fluid

volumes measured 1 week postoperatively [15]. The adhe-

sive acts to bond tissue layers together thereby reducing dead

space where seroma formation can occur while also reducing

wound drainage following surgical procedures. Over time,

hydrolysis leads to the breakdown of the adhesive and

absorption by the body. The current study was designed to

evaluate the safety and efficacy of TissuGlu in decreasing the

amount of fluid drainage and the time to drain removal in

patients undergoing abdominoplasty when compared with

standard surgical closure techniques alone.

Materials and Methods

Patient Selection

The study protocol was reviewed and approved by two

Ethics Committees (Freiburger Ethik-Kommission Inter-

national, Freiburg, Germany, and the University of Bonn,

Bonn, Germany) and written consent for participation was

obtained prior to surgery for each patient. Forty patients

undergoing abdominoplasty at three separate surgical

centers were prospectively randomized to either a control

group, in which a standard wound care (SWC) closure

technique was performed, or a treatment group, in which

the SWC closure technique was augmented with the use of

TissuGlu. Subjects included in this study were at least

20 years of age, in good general health with no condi-

tions that would significantly impact wound healing (as

determined by medical history), and were scheduled for at

least one full-thickness surgical incision of at least 20 cm

in length as part of an elective standard abdominoplasty

procedure.

Exclusion criteria for the study included obesity (BMI [30), previous abdominoplasty, current active tobacco use

including smokeless (chewing) tobacco, use of fibrin

sealants or other internal wound care devices, and medical

conditions that posed high risks for surgery, adequate

recovery, or wound healing. Patients enrolled in the study

were also not permitted to undergo liposuction or any

additional surgical procedure concomitantly with their

scheduled abdominoplasty procedure.

Baseline information obtained for all study patients

included demographic information (date of birth, gender,

height, weight, height, and BMI), indication for surgery,

medical/surgical history, list of current medications and

allergies, results of standard laboratory tests, a urine nic-

otine test, and a pregnancy test (if applicable).

Surgical Technique

The surgical procedure was consistent with standard tech-

niques used for an abdominoplasty procedure, including

skin incision with a scalpel, dissection at the level of the

abdominal fascia using electric cautery, undermining of the

abdominal flap to the xiphoid and costal margin based on

surgical judgment, and transposition of the umbilicus. The

abdominal fascia was plicated, as necessary, with perma-

nent suture. The abdominal tissue was resected with the

operating table partially flexed at the patient’s waist. Clo-

sure of the abdominoplasty in three layers (Scarpa’s fascia,

deep dermal, and intracutaneous) was performed using

standard suture material. No quilting sutures or fibrin

sealants were used for patients enrolled in either arm of the

study. Two Blake� drains (Ethicon, Inc., New Brunswick,

NJ, USA) were placed over the abdominal fascia in all

patients, and the tube was delivered through stab incisions

in the pubic area. The drains were affixed with suture and

the channeled section cut to a standard length of 12 cm.

The wound was then closed. SteriStrips� and a sterile

dressing were then applied, followed by application of an

abdominal binder (Caromed� Multiflap Binder, Mentor

Inc., Santa Barbara, CA, USA). Tumescent solutions,

wetting solutions, or any other fluids for infiltration (e.g.,

lidocaine with epinephrine), were permitted in both study

groups but were limited to use only along the incision lines

and a volume of less than 100 ml.

492 Aesth Plast Surg (2012) 36:491–496

123

For the treatment group, the surgical adhesive was

applied to the abdominal tissue surface after resection,

immediately prior to closing the flap (Fig. 1). Prior to

application of the adhesive, the incision and tunnel for the

umbilical insert were completed, hemostasis and contour

were deemed satisfactory, and the surgeon confirmed that

there was no reason to re-elevate the abdominal flap once it

was approximated (e.g., for additional plication, further

tissue resection, or suspected bleeding). The adhesive was

applied using a custom drop applicator that allowed for an

equidistant, controlled delivery of droplets of the adhesive

in an array across the tissue surface. The abdominal flap

was then approximated over the abdominal tissue surface

using a single motion to reduce the chance of smearing the

adhesive. The flap was then temporarily secured at the

incision line with a minimum of three mechanical clips

(i.e., sharp towel clips) to prevent movement while the low

transverse incision was closed (consistent with the cure

time of the adhesive). Taking steps to ensure minimal

pressure or disruption of the flap during the remaining steps

of the procedure, the umbilicus was then inset within the

previously created incision in the flap and dressing was

applied as described above.

Postoperative Care

All patients received similar postoperative care. Clinical

assessments were performed daily by a health-care profes-

sional during the hospital stay, at discharge from hospital,

and daily thereafter until both drains were removed. Crite-

rion for drain removal was fluid output below 30 ml in a 24 h

period. Additional clinical assessments were performed at

postoperative days 14, 30, and 90 (±3 days). Postoperative

parameters assessed were general clinical patient assess-

ment, including standard postoperative physical examina-

tion and wound-healing evaluation; wound drain output;

duration of hospital stay; seroma formation; other compli-

cations; and the need for additional procedures.

Outcome Measures and Statistical Analysis

Primary outcome measures for this study included time to

drain removal based upon the drain removal criterion of

less than 30 ml of fluid accumulation in a 24 h period, and

device- and non-device-related adverse events, including

their number, timing, severity, duration, and resolution,

that occurred among study subjects. Secondary outcome

measures included number of wound complications, ser-

oma formation, wound dehiscence, infection, skin necrosis,

hematoma formation, total drain volume for each patient,

length of hospitalization, number of additional physician or

clinic visits, and number/type of additional procedures due

to complications.

An analysis of variance (ANOVA) was used for the

primary statistical analysis of the primary end point. A

linear model with terms for both the treatment group and

study center was used for this analysis. A one-sided

a = 0.025 level of significance test of the following

hypothesis of superiority of SWC plus the surgical adhe-

sive relative to SWC only was conducted using an ANOVA

model. Counts and percentages of subjects reporting at

least one occurrence of each adverse device effect (ADE)

were summarized by treatment group, and similar tables

were constructed for unanticipated adverse device effects

(UADE).

Results

A total of 42 patients were screened for inclusion into the

study and 40 patients were randomized. One was excluded

as a result of tobacco use and was therefore not random-

ized. Another subject was informed about the study and

considered participation but was not scheduled for an

abdominoplasty procedure until after enrollment for the

study had been completed. In total, 20 subjects were ran-

domized to the SWC closure technique group (standard of

care) and 20 subjects to the SWC closure technique plus

surgical adhesive treatment group.

There were no significant demographic differences

between the two study groups, including no difference in

mean age or BMI (Table 1). There were also no differences

in the prevalence of major diseases or history of relevant

previous surgical procedures between the two groups. All

patients included in the standard-of-care group were

female. There was one male in the treatment group.

All patients underwent successful abdominoplasty proce-

dures as described above. There were no major intraoperative

complications reported for patients in either study group.Fig. 1 Application of the lysine-derived urethane surgical adhesive

(TissuGlu�, Cohera Medical, Inc.) during abdominoplasty procedure

Aesth Plast Surg (2012) 36:491–496 493

123

Using the drain removal criterion of less than 30 ml of fluid

accumulation in a 24 h period, the mean time to having both

drains removed was 3.7 ± 1.5 days for the control group and

2.9 ± 1.4 days for the treatment group (P = 0.13). Patients

in the control group also had a 45% higher mean total drain

volume (Fig. 2) compared with the treatment group

(303.5 ± 240.8 vs. 208.7 ± 138.23 ml; P = 0.14).

Postoperatively, three patients in the control group and

two patients in the treatment group experienced serious

adverse events. In the control group, two patients experi-

enced procedure-related hypotension, with one patient

requiring medical treatment, and one patient developed a

venous thrombosis of the right lower leg which was also

considered to be procedure-related. In the treatment group,

one patient developed a procedure-related hematoma that

required surgical revision, and another patient developed

nausea which required medical treatment. Neither of these

two adverse events in the treatment group were attributed

to the use of the surgical adhesive.

Wound-healing-related complications were reported for

four patients in each study group, with some patients

experiencing more than one complication. In the control

group, one patient had a hematoma, one patient developed

a seroma, and several patients developed minor superficial

skin infections. In the treatment group, there was one

hematoma with need for operative intervention, one deep

venous thrombosis, one case of seroma, and several

patients who developed minor superficial skin infections

unrelated to the area where the surgical adhesive was

applied. There were no device-related adverse events,

complications, or unusual reactions reported for the group

treated with the surgical adhesive.

Discussion

Clinical Impact of Postoperative Seroma

Seroma formation is the most common postsurgical com-

plication in large-flap plastic surgery procedures such as

abdominoplasty, regularly occurring in more than 10% of

cases, with higher rates for obese patients or those who had

concomitant procedures [1–5]. The management of seroma

can require multiple office visits for clinical interventions

such as repeated needle aspiration, drain replacement, and

sometimes surgical revision. In such cases, patient satis-

faction with the cosmetic outcome of the procedure can be

compromised, and the return to normal activity can be

significantly delayed.

Currently, most surgeons attempt to minimize the risk of

seroma formation by placing drains to provide a route for

wound exudate to leave the surgical site. The drains may

remain in place for days to weeks after surgery until daily

drainage volume falls below a certain threshold. Although

this approach is routine, it is only moderately effective at

reducing rates of seroma formation, as the majority of

studies reporting significant seroma rates include drain

usage as standard of care. Furthermore, drain usage in itself

can be associated with unwanted complications such as

clogging, infection, or accidental displacement, and patients

often find the drains uncomfortable or painful.

Other surgical interventions have focused on attempts to

close the ‘‘dead space’’ within the wound through the use

of PTS or quilting sutures. The placement of PTS involves

the placement of interrupted sutures between the fascia and

subcutaneous tissues to reduce the dead space between the

planes created during the dissection [11]. The use of PTS

has been shown to reduce seroma and related complica-

tions in numerous recent studies, such that many surgeons

are performing the abdominoplasty procedure in conjunc-

tion with PTS without drains [16, 17]. Antonetti and

Antonetti [16] studied 516 cases, 58 with PTS, and showed

a decrease in seroma rates from 24% in a group of 242

without PTS to 1.7% in the PTS group. Pollock and

Pollock [17] reported a 0% seroma rate in 479 cases using

Table 1 Patient demographics

Control Treatment

No. patients 20 20

Mean age (years) 40.0 ± 10.1 40.8 ± 9.3

Mean BMI (kg/m2) 25.3 ± 2.5 24.6 ± 2.8

Caucasian/White race 20 20

Female gender 20 19

Mean surface area (cm2) 463.3 ± 129.7 454.4 ± 137.0

Mean abdominal flap thickness

(mm)

29.0 ± 8.0 26.8 ± 7.1

Mean procedure time (min) 115 ± 15 142 ± 22

Mean time to ambulation (h) 6.9 ± 6.0 5.6 ± 5.4

No significant differences were noted between groups

Fig. 2 Comparison of mean total drain volume until drain is

removed

494 Aesth Plast Surg (2012) 36:491–496

123

PTS. Additionally, in some studies where drains were used

in conjunction with PTS, a reduction in complications,

drain volume, and time to drain removal has been shown

[18]. Khan et al. [18] studied two groups of abdomino-

plasty cases: one with PTS and drains and one with drains

without PTS. The mean time for drain removal was

11.9 ± 7.9 days in the non-PTS group and 9.2 ± 4.3 days

for the PTS group (not statistically significant). The seroma

rate was also reduced from 18.5% for drains without PTS

versus 6.1% in the PTS group.

In addition to the effect described from closing the dead

space, it is hypothesized that the tension sutures may help

prevent the shearing effect between the tissue planes in the

early healing phase, which may also lead to seroma [17,

19]. The major drawbacks of the PTS procedure are the

additional operative time and potential effect on cosmesis

by potentially giving rise to a dimpling effect on the skin,

decreasing patient satisfaction and aesthetic outcome [3].

Several investigative studies have been completed that

examined whether fibrin sealants can effectively reduce the

volume of drainage output in modified radical mastectomy,

in which the reported complication rate from lymphatic

drainage and seroma is 18–59% [2]. In this situation, fibrin

sealants have demonstrated no significant effect on the

incidence of postoperative seromas [20–22], the volume of

drainage output [22], or the time to drain removal [20].

Other studies have reported that the volume of fluid aspi-

rated from seromas in the fibrin treatment group was sig-

nificantly greater than the volume in the control group [23,

24]. In a recent meta-analysis of 11 separate trials [25], the

authors state that cumulative data have demonstrated fibrin

sealants do not reduce the rate of postoperative seroma or

the volume of drainage. Few published reports exist that

address the efficacy of fibrin sealants in abdominoplasty;

however, one study included a set of abdominoplasty

patients in its analysis of several procedures where a fibrin

sealant was used [26]. The authors reported that there was

no reduction in average drain volume or time to drain

removal in the abdominoplasty cohort and concluded that

the use of fibrin sealants for this procedure is of limited

clinical value.

TissuGlu� for Reduction in Wound Drainage

The goal of the current study was to evaluate the safety and

preliminary efficacy of TissuGlu Surgical Adhesive in the

reduction of wound drainage and the time to drain removal

in abdominoplasty patients. Our results demonstrated that

the adhesive reduced both the total volume of wound

drainage and the time to drain removal. Additionally, only

30% of patients in the control group had their drains

removed by 48 h compared to nearly half the patients in the

treatment group (data not shown). In addition to the

preliminary findings of efficacy, the adhesive was found to

produce no device-related complications and was deter-

mined to be safe when used as directed in abdominoplasty

procedures.

The adhesive was easy to apply using the specialized

applicator, which applied the adhesive to the tissue in an

array of drops of specified volume and spacing. The time

required to apply the adhesive was much less than the time

required for alternative methods such as quilting sutures

[3], with the application of the surgical adhesive requiring

an average of 2 ± 1 min and a maximum application time

of 5 min in one patient. Although, there was a slight

increase in procedure time for the treatment group versus

the control group in the current study, this increase was not

statistically significant and was likely a result of greater

caution during early procedures with the surgical adhesive

to ensure that there was no need to re-elevate the tissue flap

once the adhesive was applied and the flap was approxi-

mated. As experience with the technique for applying the

surgical adhesive and approximating the tissue flap

increased during the study period, this increase in operative

time was reduced.

While the reduction in total drain volume or time to

drain removal did not reach statistical significance, analysis

suggests that these differences would have achieved sig-

nificance if a larger number of patients had been enrolled in

the study. The original sample size calculation assumed

that the average time to drain removal in the standard-care

group would be 8.0 days, based on the average time to

drain removal for control patients in other abdominoplasty

studies recently reported in the literature [8, 16, 27]. The

control group in the current study performed much better

than the literature would suggest, a factor which may have

resulted from the exclusion of patient groups that are

known to have increased risk of developing complications

following abdominoplasty. Recent studies have identified

that obesity, diabetes, hypertension, smoking, the amount

of tissue removed, male gender, and having a concomitant

liposuction procedure are associated with an increased risk

of developing postsurgical complications [1, 3, 28].

Inclusion of one or more of these patient groups or an

increased enrollment of male patients in the study would

likely have increased the duration of drain use in the

control group to be more consistent with the literature

average. Further clinical studies with this surgical adhesive

in a larger patient series are recommended to confirm this

hypothesis.

While our study did not demonstrate a difference in

seroma formation between the two groups, this was pri-

marily due to seroma formation not being the primary end

point for the study. The study was designed to identify

differences in wound drainage and time to drain removal

and was not powered sufficiently to observe a difference in

Aesth Plast Surg (2012) 36:491–496 495

123

seroma formation. A larger study with more patients would

be required in order to demonstrate a potential beneficial

effect of the use of TissuGlu Surgical Adhesive on the

development of seromas.

Conclusion

The current study reports on the first clinical use of

TissuGlu Surgical Adhesive. The adhesive was found to be

as safe as the standard-of-care treatment in subjects

undergoing an elective abdominoplasty procedure with no

device-related adverse events or complications in the

treatment group. Patients treated with the surgical adhesive

experienced a decrease in the mean number of days to drain

removal and also had a decrease in total drainage volume

compared to the control, standard-of-care group. Although,

these differences did not reach statistical significance, the

trends suggest that the use of the surgical adhesive is

effective at reducing postoperative drainage allowing for

earlier drain removal.

Disclosures Dr. Klaus J. Walgenbach, Dr. Holger Bannasch, and

Dr. Stefan Kalthoff received research funding from Cohera Medical,

Inc. to conduct this study. Dr. J. Peter Rubin is a paid advisor to

Cohera Medical, Inc.

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