Topical use of hyperoxygenated fatty acids decreases surgical site infection in patients following laparoscopic cholecystectomy. A randomized controlled trial

Abstract

Background: To date, the topically effect of hyperoxygenated fatty acids (HOFA) on the control of surgical site infection (SSI) is still unclear.

Objective: To assess the effect of topical application of a HOFA solution on the umbilical trocar site after laparoscopic cholecystectomy on SSI. The occurrence of trocar site incisional hernia (TSIH) was also analyzed.

Methods: A prospective, double-blind, randomized trial was conducted in patients undergoing laparoscopic cholecystectomy, who also presented at least one of the following associated risk factors for SSI and TSIH such as Body Mass Index (BMI) above 30 kg/m², Diabetes Mellitus (DM), age over 65 years and Chronic Obstructive Pulmonary Disease (COPD). Patients were randomly allocated to topical application of a HOFA solution (HOFA arm) or saline physiological solution (non-HOFA arm) during closure of the umbilical trocar site with a polypropylene mesh. SSI was the primary outcome. TSIH was also assessed as a secondary outcome.

Results: 103 patients were included, 51 (49.5%) in the HOFA group and 52 (50.5%) in the non-HOFA group. SSI rate was significantly lower in the HOFA group in comparison with the non-HOFA group (19.6% vs. 3.8%; p = 0.028). TSIH rates were similar in both groups (3.8% vs. 2%). Multivariate analyses showed that only HOFA decreased significantly SSI rate.

Conclusion: Topical application of a HOFA solution at the umbilical trocar site after laparoscopy cholecystectomy decreased SSI rate.

Keywords: Hyperoxygenated fatty acids; Laparoscopic cholecystectomy; Prevention; Surgical site infection; Trocar site incisional hernia.