Do Antibacterial Skin Sutures Reduce Surgical Site Infections After Elective Open Abdominal Surgery?—A Prospective, Randomized Controlled Single-Center Trial

Abstract

Background/Objectives: The general use of triclosan-coated suture material (TCSM) for wound closure to prevent surgical site infections (SSIs) remains controversial. There is no conclusive evidence in the literature to support this and recommendations by professional organizations are contradictory. Therefore, the main objective of the study was to evaluate the 30-day rate of surgical site infections (SSIs) after elective open abdominal surgery using triclosan-coated versus uncoated running sutures (NCSM) for skin closure. Methods: This prospective, randomized, double-blinded study enrolled patients scheduled for open elective abdominal surgery, intraoperatively assigned to either the use of triclosan-coated or non-coated sutures for skin closure. The follow up was 30 days after surgery to detect SSIs. Secondary endpoints were wound dehiscence and reoperation rate due to wound dehiscence within 30 days, all-cause 30-day mortality and length of hospital stay. Potential risk factors for poor wound healing were evaluated in multivariate analysis. Data were analyzed in an intention to treat analysis. Results: In total, 364 patients (171 males [47%]) were randomized, 182 in either group. Six underwent urgent reoperation prior to first visit and were excluded from analysis. In the full analysis set (FAS), 358 were analyzed. SSI within 30 days occurred in 22 [12.2%] patients in the control group compared to 32 [18%] in the study group. The risk difference was not statistically significant (5.8%; 95% confidence interval (CI) −1.6–13.2%; p = 0.128). The wound dehiscence rate within 30 days was 14 of 179 [7.8%] in the NCSM group vs. 19 of 178 [10.7%] in the TCSM group. The difference in re-operation rates due to wound dehiscence was 0 of 179 [2.8%] vs. 5 of 178 [2.8%] in either group and not statistically significant (p = 0.0706). Among all patients recruited, 8 died within 30 days after surgery. Three of them died before the first assessment of the primary endpoint on day 3 and were therefore excluded from the FAS. The 30-day mortality rate was 2 of 180 [1.1%] in the NCSM group vs. 3 of 178 [1.7%] in the TCSM group. The majority of SSIs occurred in the superficial layer of the wound in both study groups (8.9% vs. 9.6%). The median [inter quartile range (IQR)] length of hospital stay was 13 [9.0, 19.2] days in the NCSM group vs. 11 [9.0, 16.8] days in the TCSM group There was a tendency towards shorter hospitalization in the study group (0.72 days [6%]). Conclusions: Our prospective randomized controlled trial could not confirm the superiority of TCSM for skin closure after elective open abdominal surgery in terms of SSI rates in a 30-day follow up period. Therefore, based on our results, a general recommendation for its use in all surgical fields cannot be justified.