Fibrin Sealant Artiss Compared to Progressive Tension Sutures With Stratafix in the Management of Wound Drainage Following Post-Bariatric Body-Contouring Surgery

Abstract

Background:

Post-bariatric body-contouring surgery is one of the most rapidly growing areas in plastic surgery. One of the most common complications following post-bariatric body-contouring surgery is seroma. There are a number of approaches to reducing wound drainage and seroma formation. A promising strategy to reduce these complications is to develop effective methods for reducing dead space between the tissue layers.

Methods:

We conducted a retrospective trial assessing the use of human fibrin sealant Artiss in comparison to progressive tension sutures (PTS) with Stratafix, a bidirectional barbed suture device in patients undergoing post-bariatric body-contouring surgery. Thirty-six patients for abdominoplasty or lower-body-lift were evaluated. Treatment patients underwent procedure with fibrin sealant applied to adapt the tissue layers. Control patients underwent an identical procedure but with PTS. Primary outcome measures included total wound drainage and time to drain removal.

Results:

The use of Artiss in abdominoplasty was associated with a mean drain volume that was significantly higher and more days that were needed to remove all drains compared to the PTS group. In body-lift, the mean drain volume and number of days needed to remove all drains tended to be higher when using Artiss compared to the PTS group.

Conclusion:

The use of Artiss in post-bariatric body-contouring surgery did not decrease the rate of seromas and the length of time required for post-surgical drains when compared to PTS.

Introduction

Post-bariatric body-contouring is one of the fastest growing areas of plastic surgery. Patients with massive weight loss who lose their weight through diet and exercise programs or through gastric bypass surgery represent an increasing population, especially as weight loss surgery is becoming increasingly safe and successful. It is therefore important to develop techniques to adapt conventional surgical methods to the new challenge. This complex population often requires extensive excision procedures. It is also important to evaluate the treatment’s outcome to improve the safety and predictability of these procedures. One of the most common complications after post-bariatric body-contour surgery is seroma formation.^1,2 There are a number of approaches to reducing wound drainage and seroma formation. A promising strategy to reduce these complications is to develop effective methods to reduce dead space between the layers of tissue. This includes the installation of closed suction drains, the use of progressive tension, or quilting suture techniques.^3-5 Pressure bandages and immobilization of the patient support reduced post-operative shear forces between layers of abdominal tissue.⁶ Studies with TissuGlu, a synthetic surgical adhesive, also showed that wound drainage volume and time for post-operative drainage decreased in abdominoplasty patients.⁷ In addition to these synthetic adhesives, fibrin glue is also used in various areas. Fibrin glue connects the tissue layers and thus reduces the dead space in which seromas can form. At the same time, wound drainage after surgery is reduced. Fibrin sealants exist of 2 components: fibrinogen and thrombin with factor XIII. The cleavage of fibrinogen by thrombin initiates a clotting process, whereas the thrombin concentration is responsible for the clotting process velocity. The lower the thrombin concentration, the slower the clotting effect sets in. This fact is very important in dealing with this adhesive so that the surgeon has time to adapt the wound surfaces carefully. Recent studies using fibrin sealants in different doses and concentrations in primarily aesthetic body-contouring surgery⁸ demonstrated an effect on eliminating seroma formation, but they also demonstrated that seroma quantity increases with weight of resected tissue. Our study is designed to evaluate the efficacy of Artiss, a 2 component tissue adhesive decreasing the amount of fluid drainage and the time to drain removal in patients undergoing post-bariatric body-contouring surgery when compared to our or the standard procedure using progressive tension sutures (PTS), here performed with Stratafix (Ethicon), a bidirectional barbed suture device.

Materials and Methods

We state that all procedures conformed to the Declaration of Helsinki. This study was approved by the Ethics Committee of Leipzig University and informed written consent to publish personal and medical information was obtained from all patients. We performed a retrospective trial assessing the use of PTS with Stratafix (Ethicon), a bidirectional barbed suture device in comparison to (human) fibrin sealant Artiss (Baxter) in patients undergoing post-bariatric body-contouring surgery. The technique of PTS was done in all the patients before we started using human fibrin sealant Artiss. In each case, patients undergoing abdominoplasty (n = 14) or lower-body-lift (n = 12) were separated into a treatment group and a control group, with the fibrin sealant applied to the anterior (abdominoplasty) or the anterior and posterior (lower body-lift) abdominal wall prior to closure in the treatment group. Control patients underwent an identical procedure with PTS using Stratafix.

The aim of this study was to assess the effectiveness of the Artiss fibrin sealant compared to the PTS technique with Stratafix in reducing the volume of wound drainage fluid in patients who have undergone an elective post-bariatric body-contouring operation. The primary end point of the study was the volume of wound drainage fluid. Baseline information obtained for all study patients included demographic information, medical history, list of current medications and allergies, and results of standard laboratory tests.

Surgical Technique

The surgical procedure was consistent with standard techniques for abdominoplasty and lower-body-lift. The umbilicus was circumscribed and the infraumbilical skin was elevated off the anterior fascia using electrocautery. The elevation was carried out supra-umbilically superiorly to the xiphoid and costal margin. The abdominal fascia was plicated in all cases. After plication, the patient was flexed into a moderate beach-chair position, and the lower excess tissue was excised after being marked. The original umbilicus site was completely excised, and no vertical incisions were used. The new position of the umbilicus was marked and incised. Two drains were placed over the abdominal fascia in all patients. In the PTS group, 2-0 Stratafix sutures were placed one above and one below the umbilicus starting from the midline in both directions. In the Fibrin Sealant group, we used Artiss, which had a thrombin concentration of 4 IU/mL. In this group, the amount of working solution was based on the area to be treated and was 6 mL for the abdominoplasty and 10 mL for the body lift.

The active ingredient was removed from the refrigerator and thawed in a sterile water bath at a temperature of 33 °C to 37 °C and heated. Thereafter, it was used in the prefabricated applicator, which united the 2 components immediately before the application and sprayed onto the wound surfaces using a sprayer. The spray application was carried out with a dedicated spray device, which did not exceed the allowable pressure of 200 kPa. The application distance was 10 to 15 cm according to the predetermined minimum distance from the tissue. For manipulation and positioning of the tissue layers, the surgeon had 60 seconds before polymerization. After positioning the flap, it had to be held in the desired position with gentle pressure for at least 3 minutes to ensure that it adhered well to the tissue surface. Thereafter, both in the PTS and in the Artiss group, the navel was recovered and fixed in its new position. The fascia and skin incision were then closed in a layered fashion as standard of care.

The lower-body-lift starts in prone position. The dissection was carried out following the preoperative markings. Two additional drains were placed in patients with lower-body-lift on the back. In the PTS group, no further sutures were placed on the back. In the Artiss group, additional 4 mL of Artiss were used, whereby the application was carried out as already described earlier. The wound closure took place here was also multilayered. Dressings and an abdominal binder were placed. All patients were positioned in bed in a flexed position and not allowed to lie flat. All patients were also required to wear the abdominal binder continuously. The primary target was the total wound drainage volume, which was determined from all drains from the end of the operation to the removal. Wound drainage was removed if the secreted fluid did not exceed 30 mL over a 24-hour period.

The primary efficacy end point had been analyzed using an analysis of covariance with the drainage volume as the dependent variable, while the covariant coordinate was denoted by the resection weight and the factors by the type of surgery and the arm. Potential influence of gender, body mass index (BMI), and other variables had been considered in an exploratory manner.

Results

The patient’s demographics of the groups showed no significant differences in age and the BMI before and after bariatric surgery, operation time, or resection weight. The objective of this study was to determine whether Artiss was an effective alternative to PTS for abdominoplasty (Table 1) and body-lift (Table 2) procedures in terms of seroma formation.

Table 1.

Abdominoplasty: Patient Demographics.

	Abdominoplasty—PTS	Abdominoplasty—Artiss	P value
Number of patients	♀5 ♂1 Σ6	♀4 ♂4 Σ8	N/A
Age	52 (range 52-59)	50 (range 32-66)	>.05
BMI in kg/m2 prebariatric	51.9 ± 7.69	50.93 ± 7.86	>.05
BMI in kg/m2 postbariatric	29.57 ± 2.53	32.41 ± 2.46	>.05
Operation time, min	105 ± 29	96 ± 23	>.05
Resection weight, g	2077 ± 823	2757 ± 1052	>.05
Drain, days	4.2 ± 1.5	7.8 ± 4.0	.027a
Drain volume, mL	445.8 ± 199.6	975.0 ± 655.3	.038a

^aFor comparison among different groups the Mann-Whitney-U-Test was used with significance assigned at P ≤ 0.05.

Table 2.

Lower Body-Lift: Patient Demographics.

	Body Lift—PTS	Body Lift—Artiss	P value
Number of patients	♀1 ♂5 Σ6	♀3 ♂3 Σ6	N/A
Age	36 (range 23-67)	44 (range 35-56)	>.05
BMI in kg/ m2 prebariatric	55.07 ± 6.98	56.65 ± 18.78	>.05
BMI in kg/m2 postbariatric	32.98 ± 3.36	32.04 ± 11.00	>.05
Operation time, min	188 ± 47	219 ± 42	>.05
Resection weight, g	4723 ± 1337	3436 ± 694	>.05
Drain, days	7.0 ± 3.7	10.0 ± 2.2	>.05
Drain volume, mL	1763.3 ± 1304.3	2505.8 ± 1095.1	>.05

Abbreviations: BMI, body mass index.

For this purpose, the average drainage days and drain volume were evaluated (Figure 1). In the abdominoplasty/PTS group in average, it took 4.2 ± 1.5 days compared to the abdominoplasty/Artiss group with 7.8 ± 4.0 days to remove all drains (P = .027*). In the abdominoplasty/PTS group, the mean drain volume was 445.8 ± 199.6 mL compared to 975.0 ± 655.3 mL in the abdominoplasty/Artiss group (P = .038*).

Figure 1.

Mean drain volume in mL per drain day.

In the body-lift/ PTS group in average it took 7.0 ± 3.7 days compared to the body-lift/ Artiss group with 10.0 ± 2.2 days to remove all drains (P > .05). In the body-lift/ PTS group the mean drain volume was 1763.3 ± 1304.3 mL compared to 2505.8 ± 1095.1 mL in the body-lift/ Artiss group (P > .05).

In addition to the total drainage volume, the drainage volume per day was determined. Here, it was found that when using Artiss™ in both the abdominoplasty and the body-lift group the drainage amount was lower in the first days than in the progressive tension groups. The highest flow rates/day were measured on average on the third day, hereafter it dropped down again. This was particularly different to the PTS groups. In these, the highest drainage volume occurred on the first day and thereafter decreased steadily without increasing again.

In addition, abdominoplasty patients showed a correlation between post-bariatric BMI and drain volume. The higher the post-bariatric BMI, the higher the drain volume (r = .64). In the body-lift group, this correlation could not be proven (r = .24).

It was also possible to establish a slight correlation between the resection weight and the drainage volume in abdominoplasty. The higher this was, the higher the drainage volume (r = .62). This correlation could not be demonstrated in body-lift (r = −.28). Gender, age or diabetes did not affect the drain volume (r ≤ .3).

Major and minor complications were recorded in each group. There were no major complications in either group. In each group, 1 patient developed minor superficial skin infections. There were no device-related adverse events, complications, or unusual reactions reported for the group treated with the fibrin sealant.

Discussion

Wound drainage and seroma formation following post-bariatric body-contouring surgery remain significant concerns to both surgeons and patients. Reasons are a prolonged return to normal body function and the increased need for narrow follow-ups. The economic impact of a hospitalization (or prolonged stay) due to seroma formation associated with this population results in high costs to the health care system and highlights the need for new approaches to minimize this complication.

The tissue manipulation, associated with this surgery, alters the healing process of the wound because of the release of a massive amount of mediators that influence both the coagulation and the complement activity and may therefore compromise the immune system.⁹ The modality of tissue dissection is a factor in hematoma and seroma formation and its quantity. Araco et al¹⁰ in post-bariatric patients performed a dissection with diathermocoagulation to reduce the occurrence of post-operative hematomas and wound infections with delayed healing compared with the cold knife. Using sharp or ultrasonic dissection rather than cautery and dissecting the abdomen in a plane superficial to the Scarpa fascia prevented the damage to the lymphatics draining into the inguinal lymph nodes is considered to cause less seroma formation.¹¹ Another reason for seroma formation after post-bariatric body-contouring surgery 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 tissue flap after surgery.¹² This shearing force may contribute to the release of inflammatory mediators which contribute to fluid accumulation. It has long been hypothesized that reduction of the dead space between layers should reduce wound drainage and thereby decrease the incidence of seroma in patients who had large-flap surgical procedures. Seroma formations are sometimes silent, but when visible, they can irritate the patient and surgeon, causing infection and impairment. The development of seroma can increase the recovery time. The seroma can also promote scar tissue formation and pressure and affect the contour result. Patients with clinically obvious seroma require further treatment methods, often in an outpatient setting, but sometimes also surgically.^{13 - 15} The amount of fluid drainage and the time to drain removal in patients undergoing post-bariatric body-contouring surgery is influenced by numerous factors. For this reason, a number of approaches have been explored to reduce wound drainage and seroma formation in body-contouring surgery.^1,3,4,11,16 It must be noted that the use of quilting suture technique described by Baroudi and Ferreira³ or the use of PTS as described by H. Pollock and T. Pollock⁴ were used in abdominoplasty surgery even before the era of bariatric surgery. In addition to the use of drainage, PTS placed between the fascia and the subcutaneous tissue imitating a quilting suture now be regarded as the standard procedure for reducing shear forces and thus reducing seroma formation.^3,4,17 Some surgeons even go so far as to completely dispense the simultaneous use of drainage when using PTS.^{18 - 20} Nevertheless, when PTS is used in combination with drainage, it can reduce the risk of seroma complications, drain volume, and time to drain removal. Khan et al²¹ reported that in 2 groups of abdominoplasty, they could lower mean time for drain removal from 11.9 ± 7.9 days in the non-PTS group to 9.2 ± 4.3 days in the PTS group. Our mean drainage time for drain removal was even lower in the comparable group at 4.2 ± 1.5 days. As a disadvantage of the use of PTS, the additional operation time and potential aesthetic impairments due to skin retractions are considered.⁵ To compensate for this disadvantage, we used Stratafix, a barbed suture material, because the linear, transversal placement of the thread distributes the tensile force evenly over the adapted surface. It is proven several times that for post-bariatric interventions, the use of barbed suture materials reduced the operation time compared to classical techniques.^{22 - 24} The principle of PTS and the associated reduction in seroma formation is based on the reduction of shear forces. A comparable effect is described for methods in which the tissue layers are interlaced with lysine-derived urethane surgical adhesives or fibrin sealants. Spring et al²⁵ and Walgenbach et al⁷ applied lysine-derived urethane surgical adhesives in less time than PTS. They state that the use of lysine-derived urethane surgical adhesive could be a safe and effective alternative to PTS to reduce seroma formation in abdominoplasty procedures. Other authors also describe a similar positive effect with the use of fibrin sealants. Toman et al⁸ described in their randomized study that the slow adhesion of the wound surfaces led to significantly lower drain volume and drainage days and thus had a clear protective effect. For Lee et al²⁶ fibrin sealants were a useful adjunct during surgical wound closure and significantly decreased seroma formation in patients undergoing post-bariatric abdominoplasty. They observed that the drainage volume in the Artiss group differed significantly in the first 24 hours from the group without fibrin sealant. We also found this during the first 24-hour period. However, it became immanent that this period could not be used for determination because using the fibrin sealant showed that the course of the drain volume did not reach its peak until the second to third day and then to decrease again. We cannot yet explain the cause of this phenomenon. However, we suspect that the PTS resulted in a stronger fixation of the tissue layers which better withstands even unavoidable tissue displacements due to the compression bandage or positioning during follow-up. These effects may have led to punctiform or planar detachments of less adherent fibrin glue, resulting in increased serous secretion. The meta-analysis of Carless et al²⁷ came to a completely opposite conclusion. In their systematic review regarding the preventive effect of the use of fibrin glue on seroma formation, they found that the use of fibrin glue did not lead to a decrease in the drain volumes or to a shorter inpatient stay. Similarly, in modified radical mastectomy, fibrin sealants have demonstrated no significant effect on the incidence of post-operative seromas or the time to drain removal.^28,29 Bercial et al³⁰ compared the seroma formation in suction drains, quilting sutures, and fibrin sealant and found that seroma formation was significantly lower in the drains and quilting groups compared to the fibrin sealant group on post-operative day 15. These results are consistent with those of our work. The comparison of the Stratafix group with the Artiss group revealed a statistically significant difference in abdominoplasty with regard to drain volumes and drainage days. Although we were able to find similar results with the body-lift, due to the low number of cases and the high fluctuations, no significance level could be achieved here. In addition, we also observed that the fibrin adhesion of the wound surfaces in comparison to the PTS clearly had no positive effect on seroma formation. Patients with larger amounts of seroma had higher post-bariatric BMI and a higher resection weight, which seems obvious, as higher post-bariatric BMI and larger resectate levels are associated with larger wound area and trauma. Our observations coincide with the results of Shermack et al¹⁵ who also found a risk factor for seroma formation in a high BMI in combination with a high resection weight. The use of Stratafix PTS reduces the operating time compared to conventional PTS. This will largely neutralize the benefit that the application of fibrin glue might have entailed. So closure technique alone cannot be the sole factor responsible for excess seroma formation and delayed healing. Reduction of the dead space between layers should reduce wound drainage and thereby decrease the incidence of seroma in patients who had large-flap surgical procedures, this alone will not work. A combination of factors right from preoperative preparation like quitting smoking to preoperative technique of flap dissection, hemostasis, obliteration of dead space to post-operative desirables like rest and pressure all add up to give the desired results. The limitation of our study is the small sample size. However, the data represent an important contribution, whether fibrin sealants would be superior to PTS for reducing seroma risk. In summary, we believe that in post-bariatric body-contouring surgery, PTS should be preferred over fibrin sealants. With barbed suture material as PTS, good aesthetic results can be achieved, which also saves time.

Conclusion

Seroma formation is one of the most common complications after abdominoplasty and lower-body-lift, which is why drainage has become established in treatment management. In order to prevent shear forces and additionally reduce seroma formation, PTS is the standard procedure. In this study, it was shown that the tissue sealant Artiss did not decrease the rate of seromas when compared to PTS. Based on these results, the use of fibrin sealant was found not to be an effective alternative to PTS for prevention of seroma formation. Barbed suture materials are a good alternative to be used as PTS.