Use of a Lysine-Derived Urethane Surgical Adhesive as an Alternative to Progressive Tension Sutures in Abdominoplasty Patients: A Cohort Study

Use of a Lysine-Derived Urethane Surgical Adhesive as an Alternative to Progressive Tension... Abstract Background Fluid accumulation is a common complication after abdominoplasty procedures, and is typically managed by the placement of post-surgical drains. Progressive tension sutures (PTS) have been shown to be an effective approach to reduce the dead space by point-wise mechanical fixation, allowing for drain-free procedures. Lysine-derived urethane surgical adhesive provides an alternative approach for mechanical fixation and reduction of dead space, and may reduce surgery time compared to PTS. Objectives This prospective, controlled, single center clinical study compared progressive tension suture wound closure technique without drains (control) to tissue adhesive wound closure technique without drains (test) during abdominoplasty surgery. The objective was to determine if lysine-derived urethane surgical adhesive is an effective alternative to PTS for drain-free abdominoplasty procedures. Methods Patients undergoing abdominoplasty who met the established inclusion/exclusion criteria were consented and enrolled in the study. Ten PTS (control) cases were performed, followed immediately by 10 tissue adhesive (test) cases. Results Surgeries were completed over an 8-month period. No statistical differences were identified between the two groups with regard to age, BMI, dissection surface area or flap weight. No clinical seroma formation was observed in either group. In the control (PTS) group, two patients developed small areas of dermal closure suture abscess requiring removal of suture material. One control patient developed drainage and fat necrosis thought to be related to PTS above the incision and later required a scar revision. One tissue adhesive patient developed hypertrophic scars of both her breast reduction and abdominoplasty scars requiring additional treatment. Conclusions Lysine-derived urethane surgical adhesive was applied in less time than PTS, even after accounting for holding pressure for 5 minutes. The tissue adhesive provided four times the number of attachment points compared to PTS, although the significance of this is not clear. Based on these results, the use of lysine-derived urethane surgical adhesive was found to be a safe and effective alternative to PTS to reduce seroma formation in drain-free abdominoplasty procedures. Level of Evidence: 2 Fluid accumulation is one of the most common complications after abdominoplasty procedures, and is typically managed by the placement of post-surgical drains. Reported rates of seroma formation with drains have varied widely from 5% to 43%1-7 bringing into question their effectiveness in minimizing fluid accumulation. Progressive tension sutures (PTS) have been shown to be an effective approach to reduce the dead space by point-wise mechanical fixation, allowing for drain-free procedures. The technique was first described by Pollock and Pollock in 2000,8 and since then, they have shown the ability of PTS to reduce complications and eliminate the need for drains in many patients studied.9-12 In their paper in 2012 with 597 cases, Pollock and Pollock reported a seroma rate of 0.1%.13 Many authors in addition to Pollock and Pollock have reported reduced fluid related complications with this technique as compared to drains.14-19 However, many surgeons remain reluctant to adopt PTS technique in lieu of fluid management with post-surgical drains. Some downsides of PTS, such as increased OR time, difficulty of placement and significant learning curve, and skin dimpling have been described in the literature.17,20 These, in addition to the time investment to master the technique, are potential barriers to wider utilization of PTS. Lysine-derived urethane surgical adhesive provides an alternative approach for mechanical fixation and may reduce surgery time compared to PTS. The technology has been previously shown as a safe and effective alternative to drains.21 The objective of this study was to determine if lysine-derived urethane surgical adhesive is a safe and effective alternative to PTS for drain-free abdominoplasty procedures by comparing progressive tension suture wound closure technique without drains (control) to tissue adhesive wound closure technique without drains (test) during abdominoplasty surgery. METHODS This clinical research protocol was submitted and approved by the Institutional Review Board at Kalispell Regional Healthcare. A single surgeon (M.S.) with 12 years of experience with drainless abdominoplasty surgery using progressive tension sutures performed all of the procedures Female patients undergoing abdominoplasty who met the established inclusion/exclusion criteria were consented and enrolled in the study. Exclusion criteria were age less than 18, body mass index greater than 35, and current tobacco use. A history of massive weight loss, previous abdominal liposuction or cryolipolysis treatments, or concomitant procedures, such as liposuction or breast surgery, were not exclusion criteria. Ten PTS (control) cases were performed, followed immediately by ten tissue adhesive (test) cases from June 2016 through February 2017. Drains were not used in any procedures. Patient demographic and comorbidity information was collected and recorded. Intraoperative data was collected such as the surface area of the abdominal wall dissection, abdominal flap weight, number of progressive tension sutures and tissue adhesive drops placed, time to place the sutures and drops, type of simultaneous procedures, and liposuction tumescence and aspiration volumes. Postoperative follow-up length and complications including seroma, hematoma, wound complications including suture abscesses, scar revisions, hypertrophic scarring, and any other complications requiring intervention were noted. The tissue adhesive used for this study was TissuGlu® Surgical Adhesive (Cohera Medical, Inc.®, Raleigh, NC). No differences in the author’s standard abdominoplasty markings were made between the cohorts, and care was taken to ensure that the surgical technique did not vary between patient groups with the exception of PTS versus tissue adhesive, including postoperative care and instructions. The area to be liposuctioned and the planned incision lines were infiltrated with a tumescent solution with lidocaine and epinephrine. Approximately a 1:1.5 ratio of aspirate to tumescent fluid for power-assisted liposuction was used. No abdominal flap liposuction was performed in any of the patients, but conservative direct excision of subscarpa’s fat was performed in patients with a thick abdominal flap. In both the tissue adhesive and the PTS technique, the umbilicus was circumscribed and the infraumbilical skin was elevated off the anterior abdominal fascia using electrocautery set on 50:50. The elevation was carried supra-umbilically in a narrower dissection over the rectus muscles superiorly to the xiphoid process. Perforators were either ligated with surgical clips or cautery for smaller vessels. All patients in this study had a rectus diastasis repair with a double-armed #2 PDO Quill (Surgical Specialties Corporation, Wyomissing, PA), as this has previously been shown to assist in long-term abdominal tightness when laxity is present.22 Once the rectus diastasis was repaired, anesthesia was asked to flex the patient into a moderate beach-chair position (approximately 45 degrees) and the lower excess tissue was excised after being tailor-tacked and marked. For all patients in the study, the original umbilicus site was completely excised and no vertical incisions were used in closure. Modifications were made as necessary to either the amount of flap to be excised, the supraumbilical dissection, or the degree of the OR table flexing to ensure closure would not be tight enough to create a “tenting” effect. Twenty cubic centimeters of 0.25% bupivacaine with epinephrine was injected into the rectus fascia for postoperative pain relief. The new location for the umbilicus was then marked approximately 1-2 cm above the umbilical stalk position to account for slightly more inferior advancement of the flap in the PTS group, and ½-1cm above the stalk in the tissue adhesive group. This is the author’s standard practice after having used both PTS and tissue adhesive in prior patients and estimating how much the flap will be advanced for incision closure. The new umbilical site skin and subcutaneous core of tissue was excised. Four 3-point tacking sutures (absorbable monofilament) were placed through the umbilical dermis, down to the fascia and pulled through the umbilical hole and tagged. These sutures were later sutured to the flap umbilical site dermis during umbilical closure. This is done in addition to telescoping a long umbilical stalk down in order to create a concave umbilicus. In the Tissue Adhesive group, the adhesive was applied in a grid pattern on the fascia per the product instructions (Figure 1) and the flap was carefully lifted, advanced inferiorly, and placed down to avoid smearing the grid. Care was taken to not overlap drops, and not drip any of the tissue adhesive on the incision-line tissue. The drop application was stopped approximately 2 cm above the incision line to avoid accidental extrusion of the tissue adhesive product if it is placed too close to the skin incision (which the author has previously experienced in the past, similar to a suture abscess). Uniform pressure was applied to the entire abdomen for 5 minutes to ensure good tissue to tissue contact and prevent flap movement during early curing. In the PTS group, 2-0 Polysorb (Covidien/Medtronic, Minneapolis, MN) quilting sutures were placed in a progressive fashion, anchoring the flap fascia to abdominal wall fascia (Figure 2). The PTS sutures were placed in 2-3 points above the umbilicus and 2-3 points below the umbilicus in the midsaggital plane while providing aggressive inferior advancement of the abdominal flap. Additional lateral quilting sutures were placed in the infraumbilical region; usually 5 to 6 sutures per side, on average totaling 16 to 17 sutures. In both study groups, three 3-point Polysorb sutures were used to close the central incision Scarpa’s fascia to the rectus fascia in order to eliminate dead space and prevent the incision line from migrating superiorly. The fascia and skin incision was then closed in a layered fashion as standard of care. Dressings and an abdominal binder were placed, and patients from both groups were moved over to the recovery bed in a flexed position and not allowed to lie flat. All patients were instructed to sleep in a flexed position and ambulate slightly hunched for one week. All patients were also required to wear an abdominal binder for 6 weeks and were allowed to return to full activity and exercise after 6 weeks. Every postoperative visit included an examination standing and supine to evaluate for a clinical seroma, defined as a palpable fluid collection or visible fluid wave. Figure 1. View largeDownload slide Progressive tension suture pattern. Figure 1. View largeDownload slide Progressive tension suture pattern. Figure 2. View largeDownload slide Tissue adhesive application pattern. Figure 2. View largeDownload slide Tissue adhesive application pattern. RESULTS All statistical analysis was performed using Minitab v.17. The 2-sample t test was used for all continuous data (age, BMI, placement time, and number of fixation points) and the Fisher’s exact test was used for all attribute data (massive weight loss, and liposuction) due to the small sample size. The patient demographics of the two groups showed no significant differences in age with a mean PTS group patient age of 46.9 years (range, 32-58 years) and a mean Tissue Adhesive group age of 43.2 years (range, 24-55 years) with a P value of 0.38 (Table 1). The mean BMI also showed no significant differences, with the PTS group being 26.2 kg/m2 and the Tissue Adhesive group being 26.1 kg/m2 with a P value of 0.96. No significant differences between the groups were found in the number of patients who had previously experienced massive weight loss (MWL) defined as >15% of total body weight. One patient in each group had experienced MWL of greater than 150 pounds, 5 years prior in the PTS group, and 7 years prior in the Tissue Adhesive group. A list of comorbidities and past abdominal procedures for both cohorts is reported in Table 4. In both patient groups, all patients were female and all patients received one or more simultaneous procedures such as breast reduction, breast augmentation, fat grafting, and liposuction (areas included flanks, hips, back, buttocks, and lower extremities). One patient in the Tissue Adhesive group had tumescence infiltrated and power-assisted liposuction of the lower abdominal flap to be used as donor fat for transfer, and this part of the abdominal flap was subsequently resected during the abdominoplasty. Liposuction was the most common simultaneous procedure performed, occurring in all but one patient in the PTS group and all patients in the Tissue Adhesive group. Postoperative follow-up ranged from 13 to 20 months (mean, 16.6 months). Figures 3-7 represent PTS and tissue adhesive patient photos at different stages of the healing process. Table 1. Patient Demographics   PTS group  Tissue adhesive group  P value  Number of patients  10  10  N/A  Gender  10 female; 0 male  10 female, 0 male  N/A  Mean age (years)  46.9 (range, 32-58)  43.2 (range, 24-55)  0.38  Mean BMI (kg/m2)  26.2 (range, 21.2-33.3)  26.1 (range, 19.9-33.1)  0.96  MWL (>15%)  10%  10%  1  Simultaneous liposuction  90%  100%  1    PTS group  Tissue adhesive group  P value  Number of patients  10  10  N/A  Gender  10 female; 0 male  10 female, 0 male  N/A  Mean age (years)  46.9 (range, 32-58)  43.2 (range, 24-55)  0.38  Mean BMI (kg/m2)  26.2 (range, 21.2-33.3)  26.1 (range, 19.9-33.1)  0.96  MWL (>15%)  10%  10%  1  Simultaneous liposuction  90%  100%  1  View Large Table 1. Patient Demographics   PTS group  Tissue adhesive group  P value  Number of patients  10  10  N/A  Gender  10 female; 0 male  10 female, 0 male  N/A  Mean age (years)  46.9 (range, 32-58)  43.2 (range, 24-55)  0.38  Mean BMI (kg/m2)  26.2 (range, 21.2-33.3)  26.1 (range, 19.9-33.1)  0.96  MWL (>15%)  10%  10%  1  Simultaneous liposuction  90%  100%  1    PTS group  Tissue adhesive group  P value  Number of patients  10  10  N/A  Gender  10 female; 0 male  10 female, 0 male  N/A  Mean age (years)  46.9 (range, 32-58)  43.2 (range, 24-55)  0.38  Mean BMI (kg/m2)  26.2 (range, 21.2-33.3)  26.1 (range, 19.9-33.1)  0.96  MWL (>15%)  10%  10%  1  Simultaneous liposuction  90%  100%  1  View Large Figure 3. View largeDownload slide (A, C, E) Preoperative and (B, D, F) 2-month postoperative photographs of a 39-year-old woman who underwent abdominoplasty with progressive tension sutures, back and flank liposuction. Figure 3. View largeDownload slide (A, C, E) Preoperative and (B, D, F) 2-month postoperative photographs of a 39-year-old woman who underwent abdominoplasty with progressive tension sutures, back and flank liposuction. Figure 4. View largeDownload slide (A, C, E) Preoperative and (B, D, F) 2-month postoperative photographs of a 33-year-old woman who underwent abdominoplasty with tissue adhesive, breast reduction, and flank liposuction. Figure 4. View largeDownload slide (A, C, E) Preoperative and (B, D, F) 2-month postoperative photographs of a 33-year-old woman who underwent abdominoplasty with tissue adhesive, breast reduction, and flank liposuction. Figure 5. View largeDownload slide (A, C, E) Preoperative and (B, D, F) 12-month postoperative photographs of a 38-year-old woman who underwent abdominoplasty with tissue adhesive and flank liposuction. Figure 5. View largeDownload slide (A, C, E) Preoperative and (B, D, F) 12-month postoperative photographs of a 38-year-old woman who underwent abdominoplasty with tissue adhesive and flank liposuction. Figure 6. View largeDownload slide (A, C, E) Preoperative and (B, D, F) 2-month postoperative photographs of a 50-year-old woman who underwent abdominoplasty with tissue adhesive, flank, and lower extremity liposuction. Figure 6. View largeDownload slide (A, C, E) Preoperative and (B, D, F) 2-month postoperative photographs of a 50-year-old woman who underwent abdominoplasty with tissue adhesive, flank, and lower extremity liposuction. Figure 7. View largeDownload slide (A, C, E) Preoperative and (B, D, F) 15-month postoperative photographs of a 34-year-old woman who underwent abdominoplasty with progressive tension sutures and flank liposuction. Figure 7. View largeDownload slide (A, C, E) Preoperative and (B, D, F) 15-month postoperative photographs of a 34-year-old woman who underwent abdominoplasty with progressive tension sutures and flank liposuction. The objective of this study was to determine if lysine-derived urethane surgical adhesive is a safe and effective alternative to PTS for drain-free abdominoplasty procedures. In order to fulfill this objective, the pertinent measures examined in both patient groups were: the mean time to place the PTS sutures versus Tissue Adhesive drops, the mean number of fixation points in each group, and patient complications. The average time to place PTS in the control group was 10.7 minutes (range, 7-18 minutes) and the average number of sutures placed was 16.6 (range, 12-22 sutures) (Table 2). In the test group, the average time to place the tissue adhesive was 0.9 minutes (range, 0.5-3.0 minutes) plus 5 minutes of holding pressure, for an average tissue adhesive total application time of 5.9 minutes (range, 5.5-8.0 minutes), and the average number of drops applied was 69.6 (range, 63-78 drops), P values < 0.001 (Table 2). Table 2. Results   PTS group  Tissue adhesive group  P value  Number of patients  10  10  N/A  Mean time to place (min) including pressure  10.7 (range, 7.0-18.0)  5.9 (range, 5.5-8.0)  <0.001  Mean no. points of fixation  16.6 (range, 12.0-22.0)  69.6 (range, 63.0-78.0)  <0.001    PTS group  Tissue adhesive group  P value  Number of patients  10  10  N/A  Mean time to place (min) including pressure  10.7 (range, 7.0-18.0)  5.9 (range, 5.5-8.0)  <0.001  Mean no. points of fixation  16.6 (range, 12.0-22.0)  69.6 (range, 63.0-78.0)  <0.001  View Large Table 2. Results   PTS group  Tissue adhesive group  P value  Number of patients  10  10  N/A  Mean time to place (min) including pressure  10.7 (range, 7.0-18.0)  5.9 (range, 5.5-8.0)  <0.001  Mean no. points of fixation  16.6 (range, 12.0-22.0)  69.6 (range, 63.0-78.0)  <0.001    PTS group  Tissue adhesive group  P value  Number of patients  10  10  N/A  Mean time to place (min) including pressure  10.7 (range, 7.0-18.0)  5.9 (range, 5.5-8.0)  <0.001  Mean no. points of fixation  16.6 (range, 12.0-22.0)  69.6 (range, 63.0-78.0)  <0.001  View Large Major and minor complications were recorded in each group, which were defined as any postoperative issue during follow-up that required intervention of any kind. There were no major complications in either group, and there were no clinically evident seromas in either group. In the PTS group, four patients experienced minor complications (Table 3). One patient received a series of steroid injections to small areas of hypertrophic scar tissue, and three patients exhibited complications related to sutures. Two patients had small areas of superficial incisional suture abscess that required removal of suture material to resolve, and this was not related to the progressive tensions sutures. One control (PTS) patient developed drainage and fat necrosis related to a PTS located above the incision and later required a scar revision. No patients had any postoperative dimpling related to PTS. In the Tissue Adhesive group, three patients experienced minor complications. One patient experienced postoperative atelectasis related to anesthesia and/or postoperative pain control, one patient experienced a skin rash from a topical incision sealant, and one patient developed hypertrophic scars of both her mastopexy and abdominoplasty incisions requiring steroid injections and eventual scar revisions. None of these complications was thought to be related to the use of the tissue adhesive. Table 3. Complications   PTS group  Tissue adhesive group  Number of patients  10  10  Seroma  0 (0%)  0 (0%)  Wound complication requiring local wound care  1 (10%)  0 (0%)  Hematoma  0 (0%)  0 (0%)  Scar treatment—Kenalog and scar revision  1 (10%)  1 (10%)  Superficial incisional suture abscess  2 (20%)  0 (0%)  Postoperative atelectasis  0 (0%)  1 (10%)  Postoperative skin rash  0 (0%)  1 (10%)  Total minor complications  4 (40%)  3 (30%)  Total major complications  0 (0%)  0 (0%)    PTS group  Tissue adhesive group  Number of patients  10  10  Seroma  0 (0%)  0 (0%)  Wound complication requiring local wound care  1 (10%)  0 (0%)  Hematoma  0 (0%)  0 (0%)  Scar treatment—Kenalog and scar revision  1 (10%)  1 (10%)  Superficial incisional suture abscess  2 (20%)  0 (0%)  Postoperative atelectasis  0 (0%)  1 (10%)  Postoperative skin rash  0 (0%)  1 (10%)  Total minor complications  4 (40%)  3 (30%)  Total major complications  0 (0%)  0 (0%)  View Large Table 3. Complications   PTS group  Tissue adhesive group  Number of patients  10  10  Seroma  0 (0%)  0 (0%)  Wound complication requiring local wound care  1 (10%)  0 (0%)  Hematoma  0 (0%)  0 (0%)  Scar treatment—Kenalog and scar revision  1 (10%)  1 (10%)  Superficial incisional suture abscess  2 (20%)  0 (0%)  Postoperative atelectasis  0 (0%)  1 (10%)  Postoperative skin rash  0 (0%)  1 (10%)  Total minor complications  4 (40%)  3 (30%)  Total major complications  0 (0%)  0 (0%)    PTS group  Tissue adhesive group  Number of patients  10  10  Seroma  0 (0%)  0 (0%)  Wound complication requiring local wound care  1 (10%)  0 (0%)  Hematoma  0 (0%)  0 (0%)  Scar treatment—Kenalog and scar revision  1 (10%)  1 (10%)  Superficial incisional suture abscess  2 (20%)  0 (0%)  Postoperative atelectasis  0 (0%)  1 (10%)  Postoperative skin rash  0 (0%)  1 (10%)  Total minor complications  4 (40%)  3 (30%)  Total major complications  0 (0%)  0 (0%)  View Large Table 4. Patient Comorbidities and Past Abdominal Procedures   PTS group  Tissue adhesive group  Previous abdominal cryolipolysis  2  0  Previous abdominal liposuction  2  1  Past smoking history  3  1  Hypertension  0  1  Asthma  2  1  Inflammatory bowel disease  1  0  Polycystic ovarian syndrome  0  1  History of gastric bypass surgery  1  1  Previous cesarean section  4  3  Previous hysterectomy  3  4  Previous appendectomy  3  2  Previous cholecystectomy  1  1  Previous bladder reconstruction  1  1  Remote history of lung cancer  0  1    PTS group  Tissue adhesive group  Previous abdominal cryolipolysis  2  0  Previous abdominal liposuction  2  1  Past smoking history  3  1  Hypertension  0  1  Asthma  2  1  Inflammatory bowel disease  1  0  Polycystic ovarian syndrome  0  1  History of gastric bypass surgery  1  1  Previous cesarean section  4  3  Previous hysterectomy  3  4  Previous appendectomy  3  2  Previous cholecystectomy  1  1  Previous bladder reconstruction  1  1  Remote history of lung cancer  0  1  View Large Table 4. Patient Comorbidities and Past Abdominal Procedures   PTS group  Tissue adhesive group  Previous abdominal cryolipolysis  2  0  Previous abdominal liposuction  2  1  Past smoking history  3  1  Hypertension  0  1  Asthma  2  1  Inflammatory bowel disease  1  0  Polycystic ovarian syndrome  0  1  History of gastric bypass surgery  1  1  Previous cesarean section  4  3  Previous hysterectomy  3  4  Previous appendectomy  3  2  Previous cholecystectomy  1  1  Previous bladder reconstruction  1  1  Remote history of lung cancer  0  1    PTS group  Tissue adhesive group  Previous abdominal cryolipolysis  2  0  Previous abdominal liposuction  2  1  Past smoking history  3  1  Hypertension  0  1  Asthma  2  1  Inflammatory bowel disease  1  0  Polycystic ovarian syndrome  0  1  History of gastric bypass surgery  1  1  Previous cesarean section  4  3  Previous hysterectomy  3  4  Previous appendectomy  3  2  Previous cholecystectomy  1  1  Previous bladder reconstruction  1  1  Remote history of lung cancer  0  1  View Large DISCUSSION In this study, lysine-derived urethane surgical adhesive was shown to be a viable alternative to PTS to eliminate the need for drains in abdominoplasty procedures. The proposed mechanisms of action of PTS are to eliminate dead space, reduce shear forces between tissue layers, and distribute tension along the entire flap as opposed to all tension on the incision line alone.8,23 Lysine-derived urethane surgical adhesive provides mechanical fixation and secures the undermined tissue flap to the abdomen prior to closure.21 This fixation is meant to eliminate dead space and the need for post-surgical drains to manage fluid during patient recovery. A level 1 randomized human study of 130 patients demonstrated the safety and efficacy of the lysine-derived urethane surgical adhesive as an alternative to drains in patients undergoing abdominoplasty surgery.21 The tissue adhesive studied has been tested for tension and shear strength with clinically relevant applied force, and in both settings the adhesive strength exceeds that of the tissue, causing the tissue to fail prior to achieving failure of the adhesive. The tensile strength has not been directly compared to different types of suture material. Numerous studies exist describing use of various fibrin-based tissue sealants in various procedures such as mastectomy,24,25 latissimus dorsi breast reconstruction,26,27 abdominal wall hernia repair,28 facelifts,29,30 as well as abdominoplasty.31 No strong consensus exists to suggest a definitive benefit of using fibrin-based sealants to reduce complications such as seroma32 in these various applications. The mechanism of action of fibrin sealants differs significantly from that of PTS and lysine-derived urethane surgical adhesive previously described in that it primarily functions as a hemostatic agent as opposed to strongly bonding tissue layers together to minimize dead space and maintain tissue-to-tissue contact during healing. In this study, it was found that the tissue adhesive achieved four times the number of attachment points that were achieved with PTS. In the abdominoplasty procedure, the tissue flap is pulled tight and mechanical fixation has been purported to help distribute that stress over multiple points instead of all the stress being concentrated on the main incision line. The ability to place more points of mechanical fixation with tissue adhesive theoretically reduces the stress at each point and could potentially reduce tissue irritation at each individual point, further facilitating patient comfort and healing. It is unknown how many of the tissue adhesive drops actually create an attachment point, just as there is no way to definitely ascertain whether all progressive tension sutures remain intact and do not pull through the tissue. The working assumption is that the increased number of adhesive drops creates more areas of adhesion, or disperses the flap adhesion points more consistently over the surface area of the flap. Whether or not these actual small areas of adhesion create the same tensile strength of a single suture has not been determined. In addition, it is known that many droplets can coalesce or smear together to form an anatomic barrier to tissue healing, possibly inadvertently increasing the risk of seroma. The tissue adhesive applicator was designed to minimize the risk of over-application, or pooling, by establishing a consistent grid pattern of droplets. The volume and spacing of the droplets were verified in preclinical studies to allow for natural tissue growth around the adhesive drops. It was found that the tissue adhesive could be applied in less time than it took to place PTS sutures, even when accounting for holding flap pressure for five minutes. Holding pressure for five minutes is not explicitly required by the product DFU. The average total time for flap adhesion with the tissue adhesive 5.9 minutes compared to 10.7 minutes to place PTS, which is statistically significant (P = 0.0004). It is important to note that the time to place PTS takes into account an efficiency that comes from many years of placing progressive tension sutures, and it is reasonable to assume that the time to place sutures may be greater for surgeons with less experience as there is a learning curve. The relative decrease in procedure time is a benefit to both the patient under anesthesia and the surgical team. The sequential method of patient enrollment was employed to represent a shift in the author’s clinical practice from PTS to tissue adhesive and allowed as much consistency as possible for each technique. Randomizing the patients would have required a separate patient consent and IRB approval process. While randomization would have been more robust, the burden of the study would have been increased for the limited number of patients studied. The study did not exclude patients with a history of preoperative abdominal liposuction, abdominal crylolipolysis, a history of massive weight loss or gastric bypass surgery, as these are patients who often are candidates for cosmetic abdominoplasty surgery. There was no statistical difference between the groups in terms of age, body mass Index, history of massive weight loss (each group had one patient who lost more than 150 pounds), or simultaneous procedures performed. However, a significant limitation to this study was the lack of randomization and the small patient number in each cohort For the purpose of this study, a visual and palpation exam was done to detect a clinical seroma during each follow-up visit. If there was no palpable or visible abnormality and no visible fluid wave, a seroma was not diagnosed. In the author’s practice, ultrasound is not used to detect seromas postoperatively. This study was designed to compare two techniques of abdominal flap dead space elimination without changing the author’s standard technique and postoperative protocol. The author does not attempt aspiration of seroma fluid that is not evident on physical examination. However, clinical examination can miss a small seroma. A follow-up study designed to include postoperative ultrasound evaluation of fluid collection in both cohorts would be very interesting and may impact future use tissue adhesive for drain-free abdominoplasty. For this study, the tissue adhesive units were purchased at $500/unit for the study patients. Currently the tissue adhesive costs $500/unit provided at least 5 units are purchased with each order, and individual price per unit is $600. Although the study was not powered to achieve statistical significance, it was noteworthy that one of the four complications in the PTS group was related to the progressive tension suture itself. The author has not encountered an area of fat necrosis around a PTS in the past, but this is obviously a potential complication if the suture encircles an area of adipose tissue and/or becomes infected. In the author’s opinion and past experience that the tissue adhesive placed too close to the incision line can also cause problems with product extrusion, similar to a superficial incisional suture abscess. It was also notable that none of the patients in either group experienced a seroma, despite both groups including a massive weight loss patient and all patients but one receiving liposuction. In the author’s practice, all patients are closed in a similar flexed table position, awakened from anesthesia and moved to the recovery bed flexed. Therefore, the two cohorts were not different in the amount of tension placed on the progressive tension sutures versus the adhesive drops due to other procedural variables. This study was done to compare sutures versus adhesive as a means to eliminate drain use, and the abdominoplasty technique was not varied in any other way. This becomes important when considering that surgeons employ different methods and extent of flap undermining, there are various ways to remove sub-Scarpa’s fat, and some surgeons close the incision in a flat position and rely on progressive tension sutures to avoid flexing the patient. None of these other abdominoplasty technique variables were evaluated in this study. It is worthwhile to note again that no abdominal flap liposuction was performed, and no procedure commonly called “lipoabdominoplasty” was utilized, referring to sculpting the abdominal flap with liposuction techniques. It is not known if adding tumescent fluid to the abdominal flap increases the risk of postoperative seroma with lysine-derived urethane surgical adhesive. It is the author’s opinion that strict postoperative adherence to abdominal binder use contributed to the absence of seromas in all of the study patients. The limitations of the study are the small sample size and the fact that a single surgeon performed all of the procedures. This may lead to outcomes that may not be easily reproducible by other operators. Outcomes may not be replicated in other situations such as in lipoabdominoplasty procedures, closing the patient in the flat position with significant tension on the incision and relying on the adhesive glue to modulate the tension, or with postoperative management that does not include an abdominal binder or allows a more rapid increase in activity. However, the data still represents an important contribution to the growing body of evidence around drain-free abdominoplasty and use of synthetic surgical adhesives to eliminate dead space. In summary, lysine-derived urethane surgical adhesive may be a viable alternative to PTS in its ability to eliminate the need for drains. Furthermore, lysine-derived urethane surgical adhesive shows the added benefit of reducing the time required to achieve mechanical fixation of the flap and increasing the number of points of fixation, even when the time to apply pressure to allow the adhesive to set up is taken into account. CONCLUSION Fluid accumulation is a common complication after abdominoplasty procedures, and is typically managed by the placement of post-surgical drains. Progression tension sutures and lysine-derived urethane surgical adhesive are techniques to create mechanical fixation of the tissue flap and eliminate the need for post-surgical drains. In this study, it was shown that the lysine-derived urethane surgical adhesive without the use of drains did not increase the rate of seromas or other postoperative complications when compared to the author’s standard technique of progressive tension suture closure. Based on these results, the use of lysine-derived urethane surgical adhesive was found to be a safe and effective alternative to progressive tensions sutures for prevention of seroma formation in drain-free abdominoplasty procedures. Disclosures The author serves as a consultant to Cohera Medical, Inc. (Raleigh, NC). Funding The author received an educational grant from Cohera Medical, Inc. to help fund this study. The grant was used to purchase the surgical adhesive for the procedures and marketing. REFERENCES 1. Mohammad JA, Warnke PH, Stavraky W. Ultrasound in the diagnosis and management of fluid collection complications following abdominoplasty. Ann Plast Surg . 1998; 41( 5): 498- 502. Google Scholar CrossRef Search ADS PubMed  2. Hensel JM, Lehman JAJr, Tantri MP, Parker MG, Wagner DS, Topham NS. An outcomes analysis and satisfaction survey of 199 consecutive abdominoplasties. Ann Plast Surg . 2001; 46( 4): 357- 363. Google Scholar CrossRef Search ADS PubMed  3. van Uchelen JH, Werker PM, Kon M. Complications of abdominoplasty in 86 patients. Plast Reconstr Surg . 2001; 107( 7): 1869- 1873. Google Scholar CrossRef Search ADS PubMed  4. Kim J, Stevenson TR. Abdominoplasty, liposuction of the flanks, and obesity: analyzing risk factors for seroma formation. Plast Reconstr Surg . 2006; 117: 773- 779; discussion 780-781. Google Scholar CrossRef Search ADS PubMed  5. Stewart KJ, Stewart DA, Coghlan B, Harrison DH, Jones BM, Waterhouse N. Complications of 278 consecutive abdominoplasties. J Plast Reconstr Aesthet Surg . 2006; 59( 11): 1152- 1155. Google Scholar CrossRef Search ADS PubMed  6. Neaman KC, Armstrong SD, Baca ME, Albert M, Vander Woude DL, Renucci JD. Outcomes of traditional cosmetic abdominoplasty in a community setting: a retrospective analysis of 1008 patients. Plast Reconstr Surg . 2013; 131( 3): 403e- 410e. Google Scholar CrossRef Search ADS PubMed  7. Najera RM, Asheld W, Sayeed SM, Glickman LT. Comparison of seroma formation following abdominoplasty with or without liposuction. Plast Reconstr Surg . 2011; 127( 1): 417- 422. Google Scholar CrossRef Search ADS PubMed  8. Pollock H, Pollock T. Progressive tension sutures: a technique to reduce local complications in abdominoplasty. Plast Reconstr Surg . 2000; 105( 7): 2583- 2586; discussion 2587. Google Scholar CrossRef Search ADS PubMed  9. Pollock H, Pollock T. Reducing abdominoplasty complications. Aesthet Surg J . 2002; 22( 5): 475- 476. Google Scholar CrossRef Search ADS PubMed  10. Pollock T, Pollock H. Progressive tension sutures in abdominoplasty. Clin Plast Surg . 2004; 31( 4): 583- 589, vi. Google Scholar CrossRef Search ADS PubMed  11. Pollock TA, Pollock H. No-drain abdominoplasty with progressive tension sutures. Clin Plast Surg . 2010; 37( 3): 515- 524. Google Scholar CrossRef Search ADS PubMed  12. Trussler AP, Kurkjian TJ, Hatef DA, Farkas JP, Rohrich RJ. Refinements in abdominoplasty: a critical outcomes analysis over a 20-year period. Plast Reconstr Surg . 2010; 126( 3): 1063- 1074. Google Scholar CrossRef Search ADS PubMed  13. Pollock TA, Pollock H. Progressive tension sutures in abdominoplasty: a review of 597 consecutive cases. Aesthet Surg J . 2012; 32( 6): 729- 742. Google Scholar CrossRef Search ADS PubMed  14. Antonetti JW, Antonetti AR. Reducing seroma in outpatient abdominoplasty: analysis of 516 consecutive cases. Aesthet Surg J . 2010; 30( 3): 418- 425. Google Scholar CrossRef Search ADS PubMed  15. Khan UD. Risk of seroma with simultaneous liposuction and abdominoplasty and the role of progressive tension sutures. Aesthetic Plast Surg . 2008; 32( 1): 93- 99; discussion 100. Google Scholar CrossRef Search ADS PubMed  16. Sforza M, Husein R, Andjelkov K, Rozental-Fernandes PC, Zaccheddu R, Jovanovic M. Use of quilting sutures during abdominoplasty to prevent seroma formation: are they really effective? Aesthet Surg J . 2015; 35( 5): 574- 580. Google Scholar CrossRef Search ADS PubMed  17. Jabbour S, Awaida C, Mhawej R, Bassilios Habre S, Nasr M. Does the addition of progressive tension sutures to drains reduce seroma incidence after abdominoplasty? A systematic review and meta-analysis. Aesthet Surg J . 2017; 37( 4): 440- 447. Google Scholar PubMed  18. Di Martino M, Nahas FX, Barbosa MV, et al.   Seroma in lipoabdominoplasty and abdominoplasty: a comparative study using ultrasound. Plast Reconstr Surg . 2010; 126( 5): 1742- 1751. Google Scholar CrossRef Search ADS PubMed  19. Macias LH, Kwon E, Gould DJ, Spring MA, Stevens WG. Decrease in seroma rate after adopting progressive tension sutures without drains: a single surgery center experience of 451 abdominoplasties over 7 years. Aesthet Surg J . 2016; 36( 9): 1029- 1035. Google Scholar CrossRef Search ADS PubMed  20. Andrades P, Prado A, Danilla S, et al.   Progressive tension sutures in the prevention of postabdominoplasty seroma: a prospective, randomized, double-blind clinical trial. Plast Reconstr Surg . 2007; 120( 4): 935- 946; discussion 947. Google Scholar CrossRef Search ADS PubMed  21. Hunstad JP, Michaels J, Burns AJ, et al.   A prospective, randomized, multicenter trial assessing a novel lysine-derived urethane adhesive in a large flap surgical procedure without drains. Aesthetic Plast Surg . 2015; 39( 4): 616- 624. Google Scholar CrossRef Search ADS PubMed  22. de Castro EJ, Radwanski HN, Pitanguy I, Nahas F. Long-term ultrasonographic evaluation of midline aponeurotic plication during abdominoplasty. Plast Reconstr Surg . 2013; 132( 2): 333- 338. Google Scholar CrossRef Search ADS PubMed  23. Khan S, Teotia SS, Mullis WF, et al.   Do progressive tension sutures really decrease complications in abdominoplasty? Ann Plast Surg . 2006; 56( 1): 14- 20; discussion 20. Google Scholar CrossRef Search ADS PubMed  24. van Bastelaar J, Theunissen LLB, Snoeijs MGJ, Beets GL, Vissers YLJ. Flap fixation using tissue glue or sutures appears to reduce seroma aspiration after mastectomy for breast cancer. Clin Breast Cancer . 2017; 17( 4): 316- 321. Google Scholar CrossRef Search ADS PubMed  25. Conversano A, Mazouni C, Thomin A, et al.   Use of low-thrombin fibrin sealant glue after axillary lymphadenectomy for breast cancer to reduce hospital length and seroma. Clin Breast Cancer . 2017; 17( 4): 293- 297. Google Scholar CrossRef Search ADS PubMed  26. Hart AM, Duggal C, Pinell-White X, Losken A. A prospective randomized trial of the efficacy of fibrin glue, triamcinolone acetonide, and quilting sutures in seroma prevention after latissimus dorsi breast reconstruction. Plast Reconstr Surg . 2017; 139( 4): 854e- 863e. Google Scholar CrossRef Search ADS PubMed  27. Lee KT, Mun GH. Fibrin sealants and quilting suture for prevention of seroma formation following latissimus dorsi muscle harvest: a systematic review and meta-analysis. Aesthetic Plast Surg . 2015; 39( 3): 399- 409. Google Scholar CrossRef Search ADS PubMed  28. Azoury SC, Rodriguez-Unda N, Soares KC, et al.   The effect of TISSEEL fibrin sealant on seroma formation following complex abdominal wall hernia repair: a single institutional review and derived cost analysis. Hernia . 2015; 19( 6): 935- 942. Google Scholar CrossRef Search ADS PubMed  29. Giordano S, Koskivuo I, Suominen E, Veräjänkorva E. Tissue sealants may reduce haematoma and complications in face-lifts: a meta-analysis of comparative studies. J Plast Reconstr Aesthet Surg . 2017; 70( 3): 297- 306. Google Scholar CrossRef Search ADS PubMed  30. Oliver DW, Hamilton SA, Figle AA, Wood SH, Lamberty BG. A prospective, randomized, double-blind trial of the use of fibrin sealant for face lifts. Plast Reconstr Surg . 2001; 108( 7): 2101- 2105, discussion 2106. Google Scholar CrossRef Search ADS PubMed  31. Bercial ME, Sabino Neto M, Calil JA, Rossetto LA, Ferreira LM. Suction drains, quilting sutures, and fibrin sealant in the prevention of seroma formation in abdominoplasty: which is the best strategy? Aesthetic Plast Surg . 2012; 36( 2): 370- 373. Google Scholar CrossRef Search ADS PubMed  32. Janis JE, Khansa L, Khansa I. Strategies for postoperative seroma prevention: a systematic review. Plast Reconstr Surg . 2016; 138( 1): 240- 252. Google Scholar CrossRef Search ADS PubMed  © 2018 The American Society for Aesthetic Plastic Surgery, Inc. Reprints and permission: journals.permissions@oup.com This article is published and distributed under the terms of the Oxford University Press, Standard Journals Publication Model (https://academic.oup.com/journals/pages/about_us/legal/notices) http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Aesthetic Surgery Journal Oxford University Press

Use of a Lysine-Derived Urethane Surgical Adhesive as an Alternative to Progressive Tension Sutures in Abdominoplasty Patients: A Cohort Study

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© 2018 The American Society for Aesthetic Plastic Surgery, Inc. Reprints and permission: journals.permissions@oup.com
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1090-820X
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10.1093/asj/sjy094
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Abstract

Abstract Background Fluid accumulation is a common complication after abdominoplasty procedures, and is typically managed by the placement of post-surgical drains. Progressive tension sutures (PTS) have been shown to be an effective approach to reduce the dead space by point-wise mechanical fixation, allowing for drain-free procedures. Lysine-derived urethane surgical adhesive provides an alternative approach for mechanical fixation and reduction of dead space, and may reduce surgery time compared to PTS. Objectives This prospective, controlled, single center clinical study compared progressive tension suture wound closure technique without drains (control) to tissue adhesive wound closure technique without drains (test) during abdominoplasty surgery. The objective was to determine if lysine-derived urethane surgical adhesive is an effective alternative to PTS for drain-free abdominoplasty procedures. Methods Patients undergoing abdominoplasty who met the established inclusion/exclusion criteria were consented and enrolled in the study. Ten PTS (control) cases were performed, followed immediately by 10 tissue adhesive (test) cases. Results Surgeries were completed over an 8-month period. No statistical differences were identified between the two groups with regard to age, BMI, dissection surface area or flap weight. No clinical seroma formation was observed in either group. In the control (PTS) group, two patients developed small areas of dermal closure suture abscess requiring removal of suture material. One control patient developed drainage and fat necrosis thought to be related to PTS above the incision and later required a scar revision. One tissue adhesive patient developed hypertrophic scars of both her breast reduction and abdominoplasty scars requiring additional treatment. Conclusions Lysine-derived urethane surgical adhesive was applied in less time than PTS, even after accounting for holding pressure for 5 minutes. The tissue adhesive provided four times the number of attachment points compared to PTS, although the significance of this is not clear. Based on these results, the use of lysine-derived urethane surgical adhesive was found to be a safe and effective alternative to PTS to reduce seroma formation in drain-free abdominoplasty procedures. Level of Evidence: 2 Fluid accumulation is one of the most common complications after abdominoplasty procedures, and is typically managed by the placement of post-surgical drains. Reported rates of seroma formation with drains have varied widely from 5% to 43%1-7 bringing into question their effectiveness in minimizing fluid accumulation. Progressive tension sutures (PTS) have been shown to be an effective approach to reduce the dead space by point-wise mechanical fixation, allowing for drain-free procedures. The technique was first described by Pollock and Pollock in 2000,8 and since then, they have shown the ability of PTS to reduce complications and eliminate the need for drains in many patients studied.9-12 In their paper in 2012 with 597 cases, Pollock and Pollock reported a seroma rate of 0.1%.13 Many authors in addition to Pollock and Pollock have reported reduced fluid related complications with this technique as compared to drains.14-19 However, many surgeons remain reluctant to adopt PTS technique in lieu of fluid management with post-surgical drains. Some downsides of PTS, such as increased OR time, difficulty of placement and significant learning curve, and skin dimpling have been described in the literature.17,20 These, in addition to the time investment to master the technique, are potential barriers to wider utilization of PTS. Lysine-derived urethane surgical adhesive provides an alternative approach for mechanical fixation and may reduce surgery time compared to PTS. The technology has been previously shown as a safe and effective alternative to drains.21 The objective of this study was to determine if lysine-derived urethane surgical adhesive is a safe and effective alternative to PTS for drain-free abdominoplasty procedures by comparing progressive tension suture wound closure technique without drains (control) to tissue adhesive wound closure technique without drains (test) during abdominoplasty surgery. METHODS This clinical research protocol was submitted and approved by the Institutional Review Board at Kalispell Regional Healthcare. A single surgeon (M.S.) with 12 years of experience with drainless abdominoplasty surgery using progressive tension sutures performed all of the procedures Female patients undergoing abdominoplasty who met the established inclusion/exclusion criteria were consented and enrolled in the study. Exclusion criteria were age less than 18, body mass index greater than 35, and current tobacco use. A history of massive weight loss, previous abdominal liposuction or cryolipolysis treatments, or concomitant procedures, such as liposuction or breast surgery, were not exclusion criteria. Ten PTS (control) cases were performed, followed immediately by ten tissue adhesive (test) cases from June 2016 through February 2017. Drains were not used in any procedures. Patient demographic and comorbidity information was collected and recorded. Intraoperative data was collected such as the surface area of the abdominal wall dissection, abdominal flap weight, number of progressive tension sutures and tissue adhesive drops placed, time to place the sutures and drops, type of simultaneous procedures, and liposuction tumescence and aspiration volumes. Postoperative follow-up length and complications including seroma, hematoma, wound complications including suture abscesses, scar revisions, hypertrophic scarring, and any other complications requiring intervention were noted. The tissue adhesive used for this study was TissuGlu® Surgical Adhesive (Cohera Medical, Inc.®, Raleigh, NC). No differences in the author’s standard abdominoplasty markings were made between the cohorts, and care was taken to ensure that the surgical technique did not vary between patient groups with the exception of PTS versus tissue adhesive, including postoperative care and instructions. The area to be liposuctioned and the planned incision lines were infiltrated with a tumescent solution with lidocaine and epinephrine. Approximately a 1:1.5 ratio of aspirate to tumescent fluid for power-assisted liposuction was used. No abdominal flap liposuction was performed in any of the patients, but conservative direct excision of subscarpa’s fat was performed in patients with a thick abdominal flap. In both the tissue adhesive and the PTS technique, the umbilicus was circumscribed and the infraumbilical skin was elevated off the anterior abdominal fascia using electrocautery set on 50:50. The elevation was carried supra-umbilically in a narrower dissection over the rectus muscles superiorly to the xiphoid process. Perforators were either ligated with surgical clips or cautery for smaller vessels. All patients in this study had a rectus diastasis repair with a double-armed #2 PDO Quill (Surgical Specialties Corporation, Wyomissing, PA), as this has previously been shown to assist in long-term abdominal tightness when laxity is present.22 Once the rectus diastasis was repaired, anesthesia was asked to flex the patient into a moderate beach-chair position (approximately 45 degrees) and the lower excess tissue was excised after being tailor-tacked and marked. For all patients in the study, the original umbilicus site was completely excised and no vertical incisions were used in closure. Modifications were made as necessary to either the amount of flap to be excised, the supraumbilical dissection, or the degree of the OR table flexing to ensure closure would not be tight enough to create a “tenting” effect. Twenty cubic centimeters of 0.25% bupivacaine with epinephrine was injected into the rectus fascia for postoperative pain relief. The new location for the umbilicus was then marked approximately 1-2 cm above the umbilical stalk position to account for slightly more inferior advancement of the flap in the PTS group, and ½-1cm above the stalk in the tissue adhesive group. This is the author’s standard practice after having used both PTS and tissue adhesive in prior patients and estimating how much the flap will be advanced for incision closure. The new umbilical site skin and subcutaneous core of tissue was excised. Four 3-point tacking sutures (absorbable monofilament) were placed through the umbilical dermis, down to the fascia and pulled through the umbilical hole and tagged. These sutures were later sutured to the flap umbilical site dermis during umbilical closure. This is done in addition to telescoping a long umbilical stalk down in order to create a concave umbilicus. In the Tissue Adhesive group, the adhesive was applied in a grid pattern on the fascia per the product instructions (Figure 1) and the flap was carefully lifted, advanced inferiorly, and placed down to avoid smearing the grid. Care was taken to not overlap drops, and not drip any of the tissue adhesive on the incision-line tissue. The drop application was stopped approximately 2 cm above the incision line to avoid accidental extrusion of the tissue adhesive product if it is placed too close to the skin incision (which the author has previously experienced in the past, similar to a suture abscess). Uniform pressure was applied to the entire abdomen for 5 minutes to ensure good tissue to tissue contact and prevent flap movement during early curing. In the PTS group, 2-0 Polysorb (Covidien/Medtronic, Minneapolis, MN) quilting sutures were placed in a progressive fashion, anchoring the flap fascia to abdominal wall fascia (Figure 2). The PTS sutures were placed in 2-3 points above the umbilicus and 2-3 points below the umbilicus in the midsaggital plane while providing aggressive inferior advancement of the abdominal flap. Additional lateral quilting sutures were placed in the infraumbilical region; usually 5 to 6 sutures per side, on average totaling 16 to 17 sutures. In both study groups, three 3-point Polysorb sutures were used to close the central incision Scarpa’s fascia to the rectus fascia in order to eliminate dead space and prevent the incision line from migrating superiorly. The fascia and skin incision was then closed in a layered fashion as standard of care. Dressings and an abdominal binder were placed, and patients from both groups were moved over to the recovery bed in a flexed position and not allowed to lie flat. All patients were instructed to sleep in a flexed position and ambulate slightly hunched for one week. All patients were also required to wear an abdominal binder for 6 weeks and were allowed to return to full activity and exercise after 6 weeks. Every postoperative visit included an examination standing and supine to evaluate for a clinical seroma, defined as a palpable fluid collection or visible fluid wave. Figure 1. View largeDownload slide Progressive tension suture pattern. Figure 1. View largeDownload slide Progressive tension suture pattern. Figure 2. View largeDownload slide Tissue adhesive application pattern. Figure 2. View largeDownload slide Tissue adhesive application pattern. RESULTS All statistical analysis was performed using Minitab v.17. The 2-sample t test was used for all continuous data (age, BMI, placement time, and number of fixation points) and the Fisher’s exact test was used for all attribute data (massive weight loss, and liposuction) due to the small sample size. The patient demographics of the two groups showed no significant differences in age with a mean PTS group patient age of 46.9 years (range, 32-58 years) and a mean Tissue Adhesive group age of 43.2 years (range, 24-55 years) with a P value of 0.38 (Table 1). The mean BMI also showed no significant differences, with the PTS group being 26.2 kg/m2 and the Tissue Adhesive group being 26.1 kg/m2 with a P value of 0.96. No significant differences between the groups were found in the number of patients who had previously experienced massive weight loss (MWL) defined as >15% of total body weight. One patient in each group had experienced MWL of greater than 150 pounds, 5 years prior in the PTS group, and 7 years prior in the Tissue Adhesive group. A list of comorbidities and past abdominal procedures for both cohorts is reported in Table 4. In both patient groups, all patients were female and all patients received one or more simultaneous procedures such as breast reduction, breast augmentation, fat grafting, and liposuction (areas included flanks, hips, back, buttocks, and lower extremities). One patient in the Tissue Adhesive group had tumescence infiltrated and power-assisted liposuction of the lower abdominal flap to be used as donor fat for transfer, and this part of the abdominal flap was subsequently resected during the abdominoplasty. Liposuction was the most common simultaneous procedure performed, occurring in all but one patient in the PTS group and all patients in the Tissue Adhesive group. Postoperative follow-up ranged from 13 to 20 months (mean, 16.6 months). Figures 3-7 represent PTS and tissue adhesive patient photos at different stages of the healing process. Table 1. Patient Demographics   PTS group  Tissue adhesive group  P value  Number of patients  10  10  N/A  Gender  10 female; 0 male  10 female, 0 male  N/A  Mean age (years)  46.9 (range, 32-58)  43.2 (range, 24-55)  0.38  Mean BMI (kg/m2)  26.2 (range, 21.2-33.3)  26.1 (range, 19.9-33.1)  0.96  MWL (>15%)  10%  10%  1  Simultaneous liposuction  90%  100%  1    PTS group  Tissue adhesive group  P value  Number of patients  10  10  N/A  Gender  10 female; 0 male  10 female, 0 male  N/A  Mean age (years)  46.9 (range, 32-58)  43.2 (range, 24-55)  0.38  Mean BMI (kg/m2)  26.2 (range, 21.2-33.3)  26.1 (range, 19.9-33.1)  0.96  MWL (>15%)  10%  10%  1  Simultaneous liposuction  90%  100%  1  View Large Table 1. Patient Demographics   PTS group  Tissue adhesive group  P value  Number of patients  10  10  N/A  Gender  10 female; 0 male  10 female, 0 male  N/A  Mean age (years)  46.9 (range, 32-58)  43.2 (range, 24-55)  0.38  Mean BMI (kg/m2)  26.2 (range, 21.2-33.3)  26.1 (range, 19.9-33.1)  0.96  MWL (>15%)  10%  10%  1  Simultaneous liposuction  90%  100%  1    PTS group  Tissue adhesive group  P value  Number of patients  10  10  N/A  Gender  10 female; 0 male  10 female, 0 male  N/A  Mean age (years)  46.9 (range, 32-58)  43.2 (range, 24-55)  0.38  Mean BMI (kg/m2)  26.2 (range, 21.2-33.3)  26.1 (range, 19.9-33.1)  0.96  MWL (>15%)  10%  10%  1  Simultaneous liposuction  90%  100%  1  View Large Figure 3. View largeDownload slide (A, C, E) Preoperative and (B, D, F) 2-month postoperative photographs of a 39-year-old woman who underwent abdominoplasty with progressive tension sutures, back and flank liposuction. Figure 3. View largeDownload slide (A, C, E) Preoperative and (B, D, F) 2-month postoperative photographs of a 39-year-old woman who underwent abdominoplasty with progressive tension sutures, back and flank liposuction. Figure 4. View largeDownload slide (A, C, E) Preoperative and (B, D, F) 2-month postoperative photographs of a 33-year-old woman who underwent abdominoplasty with tissue adhesive, breast reduction, and flank liposuction. Figure 4. View largeDownload slide (A, C, E) Preoperative and (B, D, F) 2-month postoperative photographs of a 33-year-old woman who underwent abdominoplasty with tissue adhesive, breast reduction, and flank liposuction. Figure 5. View largeDownload slide (A, C, E) Preoperative and (B, D, F) 12-month postoperative photographs of a 38-year-old woman who underwent abdominoplasty with tissue adhesive and flank liposuction. Figure 5. View largeDownload slide (A, C, E) Preoperative and (B, D, F) 12-month postoperative photographs of a 38-year-old woman who underwent abdominoplasty with tissue adhesive and flank liposuction. Figure 6. View largeDownload slide (A, C, E) Preoperative and (B, D, F) 2-month postoperative photographs of a 50-year-old woman who underwent abdominoplasty with tissue adhesive, flank, and lower extremity liposuction. Figure 6. View largeDownload slide (A, C, E) Preoperative and (B, D, F) 2-month postoperative photographs of a 50-year-old woman who underwent abdominoplasty with tissue adhesive, flank, and lower extremity liposuction. Figure 7. View largeDownload slide (A, C, E) Preoperative and (B, D, F) 15-month postoperative photographs of a 34-year-old woman who underwent abdominoplasty with progressive tension sutures and flank liposuction. Figure 7. View largeDownload slide (A, C, E) Preoperative and (B, D, F) 15-month postoperative photographs of a 34-year-old woman who underwent abdominoplasty with progressive tension sutures and flank liposuction. The objective of this study was to determine if lysine-derived urethane surgical adhesive is a safe and effective alternative to PTS for drain-free abdominoplasty procedures. In order to fulfill this objective, the pertinent measures examined in both patient groups were: the mean time to place the PTS sutures versus Tissue Adhesive drops, the mean number of fixation points in each group, and patient complications. The average time to place PTS in the control group was 10.7 minutes (range, 7-18 minutes) and the average number of sutures placed was 16.6 (range, 12-22 sutures) (Table 2). In the test group, the average time to place the tissue adhesive was 0.9 minutes (range, 0.5-3.0 minutes) plus 5 minutes of holding pressure, for an average tissue adhesive total application time of 5.9 minutes (range, 5.5-8.0 minutes), and the average number of drops applied was 69.6 (range, 63-78 drops), P values < 0.001 (Table 2). Table 2. Results   PTS group  Tissue adhesive group  P value  Number of patients  10  10  N/A  Mean time to place (min) including pressure  10.7 (range, 7.0-18.0)  5.9 (range, 5.5-8.0)  <0.001  Mean no. points of fixation  16.6 (range, 12.0-22.0)  69.6 (range, 63.0-78.0)  <0.001    PTS group  Tissue adhesive group  P value  Number of patients  10  10  N/A  Mean time to place (min) including pressure  10.7 (range, 7.0-18.0)  5.9 (range, 5.5-8.0)  <0.001  Mean no. points of fixation  16.6 (range, 12.0-22.0)  69.6 (range, 63.0-78.0)  <0.001  View Large Table 2. Results   PTS group  Tissue adhesive group  P value  Number of patients  10  10  N/A  Mean time to place (min) including pressure  10.7 (range, 7.0-18.0)  5.9 (range, 5.5-8.0)  <0.001  Mean no. points of fixation  16.6 (range, 12.0-22.0)  69.6 (range, 63.0-78.0)  <0.001    PTS group  Tissue adhesive group  P value  Number of patients  10  10  N/A  Mean time to place (min) including pressure  10.7 (range, 7.0-18.0)  5.9 (range, 5.5-8.0)  <0.001  Mean no. points of fixation  16.6 (range, 12.0-22.0)  69.6 (range, 63.0-78.0)  <0.001  View Large Major and minor complications were recorded in each group, which were defined as any postoperative issue during follow-up that required intervention of any kind. There were no major complications in either group, and there were no clinically evident seromas in either group. In the PTS group, four patients experienced minor complications (Table 3). One patient received a series of steroid injections to small areas of hypertrophic scar tissue, and three patients exhibited complications related to sutures. Two patients had small areas of superficial incisional suture abscess that required removal of suture material to resolve, and this was not related to the progressive tensions sutures. One control (PTS) patient developed drainage and fat necrosis related to a PTS located above the incision and later required a scar revision. No patients had any postoperative dimpling related to PTS. In the Tissue Adhesive group, three patients experienced minor complications. One patient experienced postoperative atelectasis related to anesthesia and/or postoperative pain control, one patient experienced a skin rash from a topical incision sealant, and one patient developed hypertrophic scars of both her mastopexy and abdominoplasty incisions requiring steroid injections and eventual scar revisions. None of these complications was thought to be related to the use of the tissue adhesive. Table 3. Complications   PTS group  Tissue adhesive group  Number of patients  10  10  Seroma  0 (0%)  0 (0%)  Wound complication requiring local wound care  1 (10%)  0 (0%)  Hematoma  0 (0%)  0 (0%)  Scar treatment—Kenalog and scar revision  1 (10%)  1 (10%)  Superficial incisional suture abscess  2 (20%)  0 (0%)  Postoperative atelectasis  0 (0%)  1 (10%)  Postoperative skin rash  0 (0%)  1 (10%)  Total minor complications  4 (40%)  3 (30%)  Total major complications  0 (0%)  0 (0%)    PTS group  Tissue adhesive group  Number of patients  10  10  Seroma  0 (0%)  0 (0%)  Wound complication requiring local wound care  1 (10%)  0 (0%)  Hematoma  0 (0%)  0 (0%)  Scar treatment—Kenalog and scar revision  1 (10%)  1 (10%)  Superficial incisional suture abscess  2 (20%)  0 (0%)  Postoperative atelectasis  0 (0%)  1 (10%)  Postoperative skin rash  0 (0%)  1 (10%)  Total minor complications  4 (40%)  3 (30%)  Total major complications  0 (0%)  0 (0%)  View Large Table 3. Complications   PTS group  Tissue adhesive group  Number of patients  10  10  Seroma  0 (0%)  0 (0%)  Wound complication requiring local wound care  1 (10%)  0 (0%)  Hematoma  0 (0%)  0 (0%)  Scar treatment—Kenalog and scar revision  1 (10%)  1 (10%)  Superficial incisional suture abscess  2 (20%)  0 (0%)  Postoperative atelectasis  0 (0%)  1 (10%)  Postoperative skin rash  0 (0%)  1 (10%)  Total minor complications  4 (40%)  3 (30%)  Total major complications  0 (0%)  0 (0%)    PTS group  Tissue adhesive group  Number of patients  10  10  Seroma  0 (0%)  0 (0%)  Wound complication requiring local wound care  1 (10%)  0 (0%)  Hematoma  0 (0%)  0 (0%)  Scar treatment—Kenalog and scar revision  1 (10%)  1 (10%)  Superficial incisional suture abscess  2 (20%)  0 (0%)  Postoperative atelectasis  0 (0%)  1 (10%)  Postoperative skin rash  0 (0%)  1 (10%)  Total minor complications  4 (40%)  3 (30%)  Total major complications  0 (0%)  0 (0%)  View Large Table 4. Patient Comorbidities and Past Abdominal Procedures   PTS group  Tissue adhesive group  Previous abdominal cryolipolysis  2  0  Previous abdominal liposuction  2  1  Past smoking history  3  1  Hypertension  0  1  Asthma  2  1  Inflammatory bowel disease  1  0  Polycystic ovarian syndrome  0  1  History of gastric bypass surgery  1  1  Previous cesarean section  4  3  Previous hysterectomy  3  4  Previous appendectomy  3  2  Previous cholecystectomy  1  1  Previous bladder reconstruction  1  1  Remote history of lung cancer  0  1    PTS group  Tissue adhesive group  Previous abdominal cryolipolysis  2  0  Previous abdominal liposuction  2  1  Past smoking history  3  1  Hypertension  0  1  Asthma  2  1  Inflammatory bowel disease  1  0  Polycystic ovarian syndrome  0  1  History of gastric bypass surgery  1  1  Previous cesarean section  4  3  Previous hysterectomy  3  4  Previous appendectomy  3  2  Previous cholecystectomy  1  1  Previous bladder reconstruction  1  1  Remote history of lung cancer  0  1  View Large Table 4. Patient Comorbidities and Past Abdominal Procedures   PTS group  Tissue adhesive group  Previous abdominal cryolipolysis  2  0  Previous abdominal liposuction  2  1  Past smoking history  3  1  Hypertension  0  1  Asthma  2  1  Inflammatory bowel disease  1  0  Polycystic ovarian syndrome  0  1  History of gastric bypass surgery  1  1  Previous cesarean section  4  3  Previous hysterectomy  3  4  Previous appendectomy  3  2  Previous cholecystectomy  1  1  Previous bladder reconstruction  1  1  Remote history of lung cancer  0  1    PTS group  Tissue adhesive group  Previous abdominal cryolipolysis  2  0  Previous abdominal liposuction  2  1  Past smoking history  3  1  Hypertension  0  1  Asthma  2  1  Inflammatory bowel disease  1  0  Polycystic ovarian syndrome  0  1  History of gastric bypass surgery  1  1  Previous cesarean section  4  3  Previous hysterectomy  3  4  Previous appendectomy  3  2  Previous cholecystectomy  1  1  Previous bladder reconstruction  1  1  Remote history of lung cancer  0  1  View Large DISCUSSION In this study, lysine-derived urethane surgical adhesive was shown to be a viable alternative to PTS to eliminate the need for drains in abdominoplasty procedures. The proposed mechanisms of action of PTS are to eliminate dead space, reduce shear forces between tissue layers, and distribute tension along the entire flap as opposed to all tension on the incision line alone.8,23 Lysine-derived urethane surgical adhesive provides mechanical fixation and secures the undermined tissue flap to the abdomen prior to closure.21 This fixation is meant to eliminate dead space and the need for post-surgical drains to manage fluid during patient recovery. A level 1 randomized human study of 130 patients demonstrated the safety and efficacy of the lysine-derived urethane surgical adhesive as an alternative to drains in patients undergoing abdominoplasty surgery.21 The tissue adhesive studied has been tested for tension and shear strength with clinically relevant applied force, and in both settings the adhesive strength exceeds that of the tissue, causing the tissue to fail prior to achieving failure of the adhesive. The tensile strength has not been directly compared to different types of suture material. Numerous studies exist describing use of various fibrin-based tissue sealants in various procedures such as mastectomy,24,25 latissimus dorsi breast reconstruction,26,27 abdominal wall hernia repair,28 facelifts,29,30 as well as abdominoplasty.31 No strong consensus exists to suggest a definitive benefit of using fibrin-based sealants to reduce complications such as seroma32 in these various applications. The mechanism of action of fibrin sealants differs significantly from that of PTS and lysine-derived urethane surgical adhesive previously described in that it primarily functions as a hemostatic agent as opposed to strongly bonding tissue layers together to minimize dead space and maintain tissue-to-tissue contact during healing. In this study, it was found that the tissue adhesive achieved four times the number of attachment points that were achieved with PTS. In the abdominoplasty procedure, the tissue flap is pulled tight and mechanical fixation has been purported to help distribute that stress over multiple points instead of all the stress being concentrated on the main incision line. The ability to place more points of mechanical fixation with tissue adhesive theoretically reduces the stress at each point and could potentially reduce tissue irritation at each individual point, further facilitating patient comfort and healing. It is unknown how many of the tissue adhesive drops actually create an attachment point, just as there is no way to definitely ascertain whether all progressive tension sutures remain intact and do not pull through the tissue. The working assumption is that the increased number of adhesive drops creates more areas of adhesion, or disperses the flap adhesion points more consistently over the surface area of the flap. Whether or not these actual small areas of adhesion create the same tensile strength of a single suture has not been determined. In addition, it is known that many droplets can coalesce or smear together to form an anatomic barrier to tissue healing, possibly inadvertently increasing the risk of seroma. The tissue adhesive applicator was designed to minimize the risk of over-application, or pooling, by establishing a consistent grid pattern of droplets. The volume and spacing of the droplets were verified in preclinical studies to allow for natural tissue growth around the adhesive drops. It was found that the tissue adhesive could be applied in less time than it took to place PTS sutures, even when accounting for holding flap pressure for five minutes. Holding pressure for five minutes is not explicitly required by the product DFU. The average total time for flap adhesion with the tissue adhesive 5.9 minutes compared to 10.7 minutes to place PTS, which is statistically significant (P = 0.0004). It is important to note that the time to place PTS takes into account an efficiency that comes from many years of placing progressive tension sutures, and it is reasonable to assume that the time to place sutures may be greater for surgeons with less experience as there is a learning curve. The relative decrease in procedure time is a benefit to both the patient under anesthesia and the surgical team. The sequential method of patient enrollment was employed to represent a shift in the author’s clinical practice from PTS to tissue adhesive and allowed as much consistency as possible for each technique. Randomizing the patients would have required a separate patient consent and IRB approval process. While randomization would have been more robust, the burden of the study would have been increased for the limited number of patients studied. The study did not exclude patients with a history of preoperative abdominal liposuction, abdominal crylolipolysis, a history of massive weight loss or gastric bypass surgery, as these are patients who often are candidates for cosmetic abdominoplasty surgery. There was no statistical difference between the groups in terms of age, body mass Index, history of massive weight loss (each group had one patient who lost more than 150 pounds), or simultaneous procedures performed. However, a significant limitation to this study was the lack of randomization and the small patient number in each cohort For the purpose of this study, a visual and palpation exam was done to detect a clinical seroma during each follow-up visit. If there was no palpable or visible abnormality and no visible fluid wave, a seroma was not diagnosed. In the author’s practice, ultrasound is not used to detect seromas postoperatively. This study was designed to compare two techniques of abdominal flap dead space elimination without changing the author’s standard technique and postoperative protocol. The author does not attempt aspiration of seroma fluid that is not evident on physical examination. However, clinical examination can miss a small seroma. A follow-up study designed to include postoperative ultrasound evaluation of fluid collection in both cohorts would be very interesting and may impact future use tissue adhesive for drain-free abdominoplasty. For this study, the tissue adhesive units were purchased at $500/unit for the study patients. Currently the tissue adhesive costs $500/unit provided at least 5 units are purchased with each order, and individual price per unit is $600. Although the study was not powered to achieve statistical significance, it was noteworthy that one of the four complications in the PTS group was related to the progressive tension suture itself. The author has not encountered an area of fat necrosis around a PTS in the past, but this is obviously a potential complication if the suture encircles an area of adipose tissue and/or becomes infected. In the author’s opinion and past experience that the tissue adhesive placed too close to the incision line can also cause problems with product extrusion, similar to a superficial incisional suture abscess. It was also notable that none of the patients in either group experienced a seroma, despite both groups including a massive weight loss patient and all patients but one receiving liposuction. In the author’s practice, all patients are closed in a similar flexed table position, awakened from anesthesia and moved to the recovery bed flexed. Therefore, the two cohorts were not different in the amount of tension placed on the progressive tension sutures versus the adhesive drops due to other procedural variables. This study was done to compare sutures versus adhesive as a means to eliminate drain use, and the abdominoplasty technique was not varied in any other way. This becomes important when considering that surgeons employ different methods and extent of flap undermining, there are various ways to remove sub-Scarpa’s fat, and some surgeons close the incision in a flat position and rely on progressive tension sutures to avoid flexing the patient. None of these other abdominoplasty technique variables were evaluated in this study. It is worthwhile to note again that no abdominal flap liposuction was performed, and no procedure commonly called “lipoabdominoplasty” was utilized, referring to sculpting the abdominal flap with liposuction techniques. It is not known if adding tumescent fluid to the abdominal flap increases the risk of postoperative seroma with lysine-derived urethane surgical adhesive. It is the author’s opinion that strict postoperative adherence to abdominal binder use contributed to the absence of seromas in all of the study patients. The limitations of the study are the small sample size and the fact that a single surgeon performed all of the procedures. This may lead to outcomes that may not be easily reproducible by other operators. Outcomes may not be replicated in other situations such as in lipoabdominoplasty procedures, closing the patient in the flat position with significant tension on the incision and relying on the adhesive glue to modulate the tension, or with postoperative management that does not include an abdominal binder or allows a more rapid increase in activity. However, the data still represents an important contribution to the growing body of evidence around drain-free abdominoplasty and use of synthetic surgical adhesives to eliminate dead space. In summary, lysine-derived urethane surgical adhesive may be a viable alternative to PTS in its ability to eliminate the need for drains. Furthermore, lysine-derived urethane surgical adhesive shows the added benefit of reducing the time required to achieve mechanical fixation of the flap and increasing the number of points of fixation, even when the time to apply pressure to allow the adhesive to set up is taken into account. CONCLUSION Fluid accumulation is a common complication after abdominoplasty procedures, and is typically managed by the placement of post-surgical drains. Progression tension sutures and lysine-derived urethane surgical adhesive are techniques to create mechanical fixation of the tissue flap and eliminate the need for post-surgical drains. In this study, it was shown that the lysine-derived urethane surgical adhesive without the use of drains did not increase the rate of seromas or other postoperative complications when compared to the author’s standard technique of progressive tension suture closure. Based on these results, the use of lysine-derived urethane surgical adhesive was found to be a safe and effective alternative to progressive tensions sutures for prevention of seroma formation in drain-free abdominoplasty procedures. Disclosures The author serves as a consultant to Cohera Medical, Inc. (Raleigh, NC). Funding The author received an educational grant from Cohera Medical, Inc. to help fund this study. The grant was used to purchase the surgical adhesive for the procedures and marketing. REFERENCES 1. Mohammad JA, Warnke PH, Stavraky W. Ultrasound in the diagnosis and management of fluid collection complications following abdominoplasty. Ann Plast Surg . 1998; 41( 5): 498- 502. 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Reprints and permission: journals.permissions@oup.com This article is published and distributed under the terms of the Oxford University Press, Standard Journals Publication Model (https://academic.oup.com/journals/pages/about_us/legal/notices)

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Aesthetic Surgery JournalOxford University Press

Published: Apr 7, 2018

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