OBJECTIVE
To compare wound complication rates after skin closure with staples versus subcuticular suture in obese gynecology patients undergoing laparotomy through midline vertical incision.
METHODS
In this randomized controlled trial, women with a body mass index (BMI) ≥ 30 kg/m2 undergoing surgery by a gynecologic oncologist through midline vertical incision were randomized to skin closure with staples or subcuticular 4-0 monofilament suture. The primary outcome was the rate of wound complication, defined as the presence of a wound breakdown, or infection, within eight weeks postoperatively. Secondary outcomes included operative time, Stony Brook scar cometic score, and patient satisfaction. A sample size of 162 was planned to detect a 50% reduction in wound complications. At planned interim review (n=82), there was no significant difference in primary outcome.
RESULTS
Between 2013 and 2016, 163 women were analyzed, including 84 who received staples and 79 suture. Women who received staples were older (mean age 59 vs. 57 years), had lower mean BMI (37.3 vs 38.9 kg/m2), and fewer benign indications for surgery (22 vs. 27). There were no differences in wound complication rates between staple versus suture skin closure [28 (33%) vs. 25 (32%), relative risk (RR) 1.05, 95% confidence interval (CI) 0.68–1.64]. Women with staples reported worse median cosmetic scores (4/5 vs. 5/5, P<0.001), darker scar color (37 (49%) vs. 13 (18%), RR 2.69, 95%CI 1.57–4.63), and more skin marks [30 (40%) vs. 3 (4%), RR 9.47, 95% CI 3.02–29.65] compared to women with suture closure. There was no group difference regarding satisfaction with their scar. Stepwise multivariate analysis revealed BMI (OR 1.13, 95% CI 1.07–1.20), maximum postoperative glucose (OR 1.01, 95% CI 1.00–1.01), and cigarette smoking (OR 4.96, 95% CI 1.32–18.71) were correlates of wound complication.
CONCLUSION
Closure of midline vertical skin incisions with subcuticular suture does not reduce surgical site wound complications compared to staples in obese gynecology patients.