Randomized Prospective Study Comparing Conventional Subcuticular Skin Closure With Dermabond Skin Glue After Saphenous Vein Harvesting

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1 Randomized Prospective Study Comparing Conventional Subcuticular Skin Closure With Dermabond Skin Glue After Saphenous Vein Harvesting Bhuvaneswari Krishnamoorthy, BS,* Osman Najam, MBChB,* Ursalan A. Khan, MBChB, Paul Waterworth, FRCS (CTh), James E. Fildes, PhD, and Nizar Yonan, FRCS (CTh) Department of Cardiothoracic Surgery, and The Transplant Centre, University Hospital of South Manchester NHS Foundation Trust, and The School of Translational Medicine, Faculty of Human and Life Sciences, University of Manchester, Manchester, United Kingdom Background. Dermabond (Ethicon UK, Edinburgh, United Kingdom) is a topical skin adhesive used for surgical wound closure, with purported advantages over conventional sutures on cosmetic outcomes, cost benefits, and operative times. This study compared results of skin closure using Dermabond and subcuticular sutures after coronary artery bypass grafting (CABG). Methods. The study prospectively enrolled and randomized 106 patients who underwent CABG. The groups received closure with Dermabond skin glue or subcuticular sutures (n 53 each) after saphenous vein harvesting using the bridging technique. Wound closure time for the two methods was recorded. Cosmetic appearance was assessed using the Hollander, the Vancouver, and the visual analog scale. Patient satisfaction was recorded before discharge and at week 6. Results. There were no significant differences in the total operative time between the two groups (p 0.43). Closure time was significantly shorter in the Dermabond group (p 0.017). Patients in the Dermabond group also reported superior cosmetic outcome at weeks 1 (p < 0.001) and 6 (p 0.001) and improved patient satisfaction (p < 0.001). Conclusions. Dermabond has demonstrated superiority over traditional subcuticular skin sutures in terms of closure time, cosmetic appearance, and patient satisfaction. This technique provides a novel method of wound closure after CABG. (Ann Thorac Surg 2009;88: ) 2009 by The Society of Thoracic Surgeons Coronary artery bypass grafting (CABG) is one of the most commonly performed procedures in the cardiothoracic speciality [1]. Subcuticular suturing has been the traditional method of wound closure after vein harvesting. Although reliable and inexpensive, sutures may take longer to place, with the additional risk of needle stick injury to the surgeon and the operating staff [2]. The removal of the entire portion of the long saphenous vein may be required for multiple grafts, resulting in multiple incisions along the length of the leg. Complications from wound healing may often be protracted and costly, and are said to occur in 2% to 24% of cases [3, 4]. Despite numerous complications, including infection, dehiscence, and an unsightly scar, little attention has been paid to the leg wound in CABG operations and, in particular, the cosmetic appearance of the scar. Dermabond (2-octylcyanoacrylate; Ethicon UK, Edinburgh, United Kingdom) is a topical tissue adhesive that upon contact with a weak base forms a strong polymeric bond across opposed wound edges allowing the normal Accepted for publication June 18, *Both authors contributed equally. Address correspondence to Dr Fildes, The Transplant Centre, University Hospital of South Manchester NHS Foundation Trust, Manchester, M23 9LT, United Kingdom; james.fildes@manchester.ac.uk. healing process to occur. The use of 2-octylcyanoacrylate has been studied in various surgical specialities for primary wound closure. Benefit has been especially observed with use in laceration repair, plastic surgery, and oral and maxillofacial surgery [5 7]. This study evaluated the use of Dermabond after vein harvesting in CABG, and compared Dermabond with conventional subcuticular sutures in terms of cosmetic appearance of the scar, closure time of the two procedures, and eventual patient satisfaction. Material and Methods The Ethics Committee of the South Manchester Health Authority approved this investigation. Patients provided informed consent. Patients and Randomization The study prospectively enrolled 106 patients who underwent elective CABG at the University Hospital of South Manchester NHS Foundation Trust. A computerized randomization system was used to place patients into two groups of 53 each. Wound closure was with Dermabond skin glue in one group and with subcuticular sutures in the other by The Society of Thoracic Surgeons /09/$36.00 Published by Elsevier Inc doi: /j.athoracsur

2 1446 KRISHNAMOORTHY ET AL Ann Thorac Surg SKIN CLOSURE USING DERMABOND 2009;88: Fig 1. The Hollander scale was used to assess the scar site on day 7. The subcuticular sutures in this patient show step-off borders, contour irregularities, margin separation, edge inversion, and excessive distortion. depending on branch size. Care was taken not to damage the saphenous nerve and its branches. In the suture group (n 53), continuous subcuticular and subcutaneous sutures were used (monofilament synthetic absorbable Biosyn 3 0; Covidien PLC, Dublin, Ireland), the wound was dressed with Mepore dressing (Mölnlycke Health Care, Manchester, United Kingdom), and a pressure bandage was applied for 48 hours. In the Dermabond group (n 53), the wound was closed with subcutaneous sutures, skin approximated, and the skin glue applied. Dermabond was applied in two layers over the edges of the skin after complete drying. A gap of a few seconds occurred between the application of the two layers. A pressure bandage and Steri-Strips (3M, St Paul, MN) were applied to hold the edges together for 24 hours. Demographic data were collected, including gender, age, race, body mass index, preoperative medication, and presence of diabetes or peripheral vascular disease. Clinical variables included incidence of wound complications, cosmetic results, and patient satisfaction early and late after the operation. The study was powered to have 53 patients in each randomized group (106 in total), with 80% power to detect differences in the total cosmetic score (ranging from 0 to 6) of 1.1 or more between the groups. This assumed a common standard deviation of two and a conventional 5% significance level, where values of p 0.05 were considered significant. Surgical Technique Our center has adopted the minimally invasive vein harvesting (bridging) technique as the primary method for CABG, because evidence has suggested it is beneficial in reducing wound-related problems [8, 9]. Skin incisions of 2 to 3 cm were made over the long saphenous vein during open vein harvesting. Intermittent gaps of approximately 6 to 7 cm were left between these incisions. The vein was exposed and dissected through tunnels using West and Langenbeck retractors and Metzenbaum scissors. Titanium clips were used for the side branches, Wound Assessment The Hollander wound evaluation grading scale was used for the first 7 days postoperatively and the Vancouver Scar Scale at 6 weeks. The Hollander Wound Registry is a validated tool for standardization of wound surveillance with grading of 6 clinical cosmetic categories, including step-off borders, contour irregularities, scar width, excessive inflammation, edge inversion, and overall cosmetic appearance [10]. For each category, a score of 0 or 1 was assigned, and the total score from the 6 categories was combined and recorded. A score greater than 0 reflected suboptimal cosmesis. The Vancouver Scar Scale assesses 4 categories, including vascularity, pigmentation, pliability, and height of scar, with increasing scores reflecting more severe disfigurement [11]. The total score ranges between 0 and 14, whereby a score of 0 reflects normal skin. Two surgeons independent of the study who were blinded to the type of skin closure rated photographs at the same time points using a visual analog scale evaluating cosmetic appearance and the previously validated Hollander wound evaluation scale. A patient satisfaction score modified from the Patient and Observer Scar Assessment Scale [11] and the visual analog scale [12] was used at discharge and at 6 weeks postoperatively. The patients rated their satisfaction of cosmetic outcome on a horizontal Fig 2. The cosmetic appearance of the scar on day 7 was assessed using the Hollander wound evaluation grading scale. Categories, which included step-off borders, contour irregularities, scar width, excessive inflammation, edge inversion, and overall cosmetic appearance, were assigned a score of 0 or 1. The scores were combined, and a total score exceeding 0 reflects suboptimal cosmesis. Dermabond provided significantly (p 0.001, Fisher exact test) better cosmesis compared with subcuticular sutures. No patients in the suture group scored 0.

3 Ann Thorac Surg KRISHNAMOORTHY ET AL 2009;88: SKIN CLOSURE USING DERMABOND 1447 closure by an operating theater technician not involved in the study who used a digital timer. The scar site was also inspected for any signs of inflammation, hematoma, or exudation. Results Of the 106 patients enrolled in the study, men comprised 77.4% of the suture group and 84.9% of the Dermabond group. We identified and excluded an additional 12 patients who required emergency CABG, redo procedures, those with varicose veins as assessed by a thorough history and physical examination, small or thin legs, and those with a superficial long saphenous vein after randomization. The exclusion criteria were designed to eliminate patients who had increased risk of vein harvesting failure during CABG. The small number of women studied reflects the gender differences in the incidence of coronary artery disease. After risk stratification of patient demographics, no significance was noted between the suture and Dermabond groups. Cosmetic Appearance All wounds were evaluated on day 7 postoperatively by 2 surgeons using the Hollander scale, where assessment of step-off borders, contour irregularities, margin separation, edge inversion, and excessive distortion were recorded. All patients in the Dermabond group scored 0, whereas in the suture group, 32.1% scored 1, 41.5% scored 2, 22.6% scored 3, and 3.8% scored 4 (p 0.001; Fig 1). No patients in the suture group scored 0 (Fig 2). There were no significant interobserver differences between the 2 surgeons (p 0.45). Fig 3. The appearance of the scar after saphenous vein harvesting using traditional subcuticular sutures is shown at (A) 1 week and (B) 6 weeks. Closure with Dermabond is shown at (C) 1 week and (D) 6 weeks. line scale of 100 mm. The color, size, thickness, pliability, and visibility were assessed, as well as overall satisfaction with the scar compared with normal skin. Patients were also asked to rate whether the scar was painful or pruritic. Closure time of the two procedures was calculated from the time vein harvesting was complete to skin Fig 4. Closure time was significantly (p 0.017) shorter for Dermabond compared with sutures. Closure time was calculated from the time vein harvesting was complete to the end of skin closure. Error bars show 95% confidence interval.

4 1448 KRISHNAMOORTHY ET AL Ann Thorac Surg SKIN CLOSURE USING DERMABOND 2009;88: At 6 weeks, cosmetic appearance was compared between the two groups using the Vancouver scale and analyzed using the Fisher exact test. The Dermabond group scored significantly better in cosmetic appearance (p 0.001; Fig 3). The postoperative analysis of skin pigmentation in the Dermabond group at 6 weeks displayed less visibility of the scar site (Fig 3). Hyperpigmentation was noted in all patients in the subcuticular suture group. This was verified by a team of surgeons and cosmetic nurses, with no significant interobserver variation (p 0.13). Comparative analysis of the two groups did not display any significant differences in the incidence of inflammation, hematoma, or exudation from the incision site (p 0.39), with 6 patients in the suture group and 5 in the Dermabond group in total showing signs of inflammation, hematoma, or exudation. Operative Times According to a Mann-Whitney analysis, no significant differences in total operative time (p 0.43) or time taken for long saphenous vein harvesting (p 0.99) were noted between the two groups. The median operative time for both groups was 45 minutes. Skin closure time was significantly shorter in the Dermabond group (p 0.017, Fig 4). The median closure time in the Dermabond group was 10 minutes 45 seconds compared with 13 minutes 20 seconds in the suture group. The absolute time to closure in the Dermabond group was 10 minutes 24 seconds, compared with 15 minutes 9 seconds in the suture group. Patient Satisfaction Patient satisfaction was assessed upon discharge and at 6 weeks. There was no difference between the two groups at discharge (p 0.99). At 6 weeks, however, patients in the Dermabond group reported significantly greater satisfaction with the scar compared with the suture group (p 0.001). The color and visibility of the scar at 6 weeks were superior to conventional subcuticular sutures. No significant differences were noted in satisfaction with scar size (p 0.67). Comment A trend is emerging for the use of Dermabond in head, neck and pediatric surgery, with benefits of ease of use, formation of a flexible water-resistant barrier, and decreased operative times [13, 14]. These benefits are yet to transpire into cardiothoracic surgery, and wound closure in most CABG patients is currently by the traditional method of subcuticular suturing. However, impaired wound healing may contribute to an increased likelihood of infection, poor cosmetic appearance, prolonged hospital stay, and patient dissatisfaction. In our study, the use of Dermabond reduced wound closure time during CABG, resulting in better cosmetic appearance and higher patient satisfaction compared with subcuticular sutures. Reduction in wound closure time with Dermabond may provide significant benefit without affecting aesthetic outcomes. This has been previously noted with long incisions [5]. Prolonged exposure during surgical wound closure increases the likelihood of postoperative infections. Use of Dermabond reduces this exposure, and hence the risk. The ease of use and lack of intricacy with tissue adhesives compared with suturing may be beneficial in reducing operative time during CABG. Although data on the cost-effectiveness of Dermabond is lacking, reduction in the overall costs associated with tissue adhesives has been reported due to lower costs of surgeons, consumption of less material during the procedure, and absence of repeat appointments when nonabsorbable sutures are used [15]. Tissue adhesives produce comparable cosmetic outcomes to standard wound closure techniques in traumatic lacerations and incisional surgical wounds [16] as well as after plastic surgery procedures [17]. Our study provides data suggesting Dermabond use results in better cosmesis after CABG compared with traditional subcuticular sutures. Cosmetic appearance of a scar depends largely on surgical proficiency, where a long period of learning is required for the surgeon to achieve optimal cosmesis in wound closure [18]. However, the time required to obtain competency for the use of tissue adhesives is considerably shorter [19] and may help explain the superior results observed in this study. Furthermore, these findings indicate that Dermabond should be used as the primary method of wound closure. Dermabond use also resulted in improved patient satisfaction with the scar 6 weeks postoperatively compared with subcuticular sutures. This superiority has been previously reported in other surgical procedures [20]. Other patient benefits include being able to shower almost immediately after the procedure [20]. Furthermore, the risk of allergic reactions associated with sutures is reduced, and no suture needles are required [21]. Tissue adhesives have gained favor for their quick and painless closure of lacerations, thus reducing the need for a local anesthetic. In addition, Dermabond sloughs off the incision site in 5 to 10 days; therefore, unlike with nonabsorbable sutures, the patient is not required to return to the hospital [22]. Formation of suture sinuses due to infected suture material has also been reported with the use of absorbable [23] and nonabsorbable [24] sutures. These present a significant problem postoperatively, persisting over several months and producing a seropurulent discharge, which may be avoided with the use of Dermabond. No significant differences were demonstrated in the incidence of inflammation, hematoma, or exudation from the incision site with either closure method. This is in keeping with the literature, where previous studies demonstrate either a decrease [7, 25] or no difference [26, 27] in the incidence of postoperative infections with Dermabond. Complications after CABG, such as superficial and deep wound infections, wound dehiscence, and cellulitis [28, 29], restrict patient mobility and increase rehospitalization and are associated with increased direct and indirect costs [30]. In severe cases, the loss of limbs has also been reported [31]. Dermabond creates a physical antimicrobial barrier that may be advantageous in preventing wound infection [7, 25]. The findings of our study

5 Ann Thorac Surg KRISHNAMOORTHY ET AL 2009;88: SKIN CLOSURE USING DERMABOND indicate that both methods are comparable in the incidence of wound complications such as inflammation and hematoma. In conclusion, the benefits of using tissue adhesives in wound closure after vein harvesting for CABG are not fully appreciated. Dermabond may help reduce operative time, increase patient satisfaction, and improve cosmetic appearance compared with traditional suturing. It may also assist in reducing the overall costs and produce comparative infection risk. Disclosures and Freedom of Investigation Dermabond was provided free of charge as a donation from Ethicon Inc, United Kingdom. All aspects of this study, including but not limited to design of the study, methods used, outcome variables, analysis of data, and production of the written report, were under the direct control of the investigators, with no input (financial or otherwise) from any sources, including Ethicon Inc. 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