A Randomized Clinical Trial Comparing a New Coaptive Film ...
A Randomized Clinical Trial Comparing a New Coaptive Film Device Versus Subcuticular Closure of Linear Incisions
Carolyn L. Kerrigan, MD and Thom L. Walsh, MSc
Introduction: Multiple techniques for wound closure are available. The ideal wound closure should be achieved quickly with minimal patient discomfort and an optimal scar. The purpose of this study was to compare traditional subcuticular wound closure (SC) with a new unique film device (SteriStrip-S = SSS). We tested three hypotheses: 1) SSS is faster, thus saving operative time, compared to SC; 2) SSS is as comfortable for patients as SC; 3) SSS results in superior scars compared to SC.
Methods: Patients undergoing bilateral Wise pattern breast reduction (BBR) or an abdominal procedure, TRAM or abdominoplasty (ABD), were eligible for participation. Study subjects initially recruited were excluded if their surgeon determined that SSS would not adequately approximate the wound margins. The study design resulted in random assignment of incisions to SSS or SC. Each patient in the study had “paired” incisions such that incisions in similar anatomic regions were closed with alternate techniques (Figure 1). This allowed each patient to serve as their own control and minimize the confounding factor of systemic influence on final scar appearance. The main outcome measures were time taken to close the superficial portion of the wound, patient comfort and scar quality. Closure time was recorded intraoperatively, with a stopwatch, in minutes and seconds. The level of training of the surgeon performing both the deep dermal and superficial closure was recorded for analysis as a potential confounder. In order to derive meaningful estimates of potential savings in operating room time, the time data was extrapolated to represent a complete procedure using either SSS or SC. Patient self-assessment of comfort was recorded at 7-12 days postoperatively using a 10 cm VAS. At 6-9 months postoperatively scars will be evaluated by study subjects, photographed and rated by an expert panel. Statistical Analysis: Student T-tests were used to compare the main outcome measures.
Results: From February 2006 until May 2007 32 patients have consented to participate, had surgery and completed the postoperative comfort survey (Figure 2). Patient recruitment is ongoing.
Time: 45 BBR incisions segments were closed by SSS and 45 by SC. 17 abdominal incision segments were closed by SSS and 17 by SC. Mean time for closure of BBR incisions by SSS and SC was 1.9 min (sd = 1.2) and 5.5 min (sd = 2.8) respectively. This difference was statistically significant, p>0.00001. Mean time for closure of ABD incisions was 5.0 min (sd = 1.6) and 10.1 min (sd = 2.7) respectively. This difference was statistically significant, p>0.00001. Extrapolating these results to surgical case length, a BBR incision closed entirely by SSS, would save 20.1 minutes of operative time (11.8 vs 31.9) compared to SC closure. Likewise, a typical ABD incision closed entirely with SSS would save 10.4 minutes of operative time (9.9 vs 20.3) compared to SC closure (Figure 3).
Patient Comfort: To date, 32 patients have rated their comfort level. The mean comfort scores for SSS and SC were 6.84 (sd = 2.2) and 7.60 (sd = 1.8) out of 10 on the VAS (Figure 4). This difference was not statistically significant, p = 0.2057. Comfort level between breast and abdominal incision sites was not different for either closure technique. The results of the 6 month scar evaluations will be reported in a separate paper.
Conclusions: SSS permits faster wound closure than SC and patients report no statistical difference in comfort. Use of SSS offers a time efficient alternative to SC for the closure of long linear incisions such as found with Wise pattern breast reductions and abdominoplasty, panniculectomy or TRAM flap donor sites.
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