Surgipler Skin Stapler versus Trulon Polyamide Suture in Post-surgical Open Abdominal Wound Closure: A Randomised Clinical Trial

Abstract

Introduction: Surgical wound closure is the process of closing incised skin to facilitate rapid wound healing with a low risk of complications and an appealing cosmetic outcome. The method and material for wound closure are influenced by the type of surgery, the anatomical site of the wound, and the length of the incision. It must serve both functional and aesthetic purposes with fewer complications. Aim: To compare the rate of Surgical Site Infection (SSI) between skin staplers and polyamide sutures among patients undergoing open abdominal surgeries. Materials and Methods: The present study was a singlecentre, prospective, two-arm, parallel-group, randomised (1:1) clinical study conducted at the Department of General Surgery, IPGMER-SSKM Hospital, Kolkata, West Bengal, India, between July 19, 2022, and January 31, 2023. A total of 134 eligible adult patients (18-70 years) undergoing open abdominal surgeries were screened, enrolled, and randomised to the Surgipler skin stapler (n=67) and Trulon polyamide suture (n=67). Patients were followed up for 84 days. The primary objective was to compare the rate of SSI between the two groups. The secondary objectives were evaluation of wound complications, postoperative pain, patient satisfaction, cosmetic appearance of the wound, time taken for skin closure, ease of use, and safety of the two interventions. The statistical analysis was performed using the Analysis of Variance (ANOVA) test for continuous variables. A p-value <0.05 was considered significant. Results: The Surgipler skin stapler performed better than the Trulon polyamide suture in postoperative wound closure of open abdominal surgeries, based on the percentage of SSI (2.98% vs. 4.47%), skin closure time (387.99±116.40 vs. 578.57±139.22 seconds), patient satisfaction score (4.20±0.53 vs. 2.69±0.57), the overall Patient and Observers Scar Assessment Scale (POSAS) observers score (1.17±0.39 vs. 2.44±0.69), and the overall POSAS patient score (1.24±0.47 vs. 2.50±0.76) at the end of the study. All parameters had a statistically significant p-value <0.0001. Conclusion: The present study concludes that the Surgipler skin stapler performed better than the Trulon polyamide suture in postoperative wound closure in open abdominal surgeries.

Keywords

• cosmetic appearance
• patient and observers scar assessment scale
• patient satisfaction
• surgical site infection
• wound complication