Abstract
BACKGROUND: The aim of this study was to assess the usefulness of protective negative-pressure wound therapy (NPWT) in the reduction of wound healing complications (WHC) and surgical site infections (SSI) after diverting ileostomy closure in patients who underwent surgery for colorectal cancer. METHODS: In this prospective randomized clinical trial in a tertiary academic surgical center, patients who had colorectal cancer surgery with protective loop ileostomy and were scheduled to undergo ileostomy closure with primary wound closure from January 2016 to December 2018 were randomized to be treated with or without NPWT. The primary endpoint was the incidence of WHC. Secondary endpoints were incidence of SSI, length of postoperative hospital stay (LOS), and length of complete wound healing (CWH) time. RESULTS: We enrolled 35 patients NPWT (24 males [68.6%]; mean age 61.6 ± 11.3 years), with NPWT and 36 patients (20 males [55.6%]; mean age 62.4 ± 11.3 years) with only primary wound closure (control group). WHC was observed in 11 patients (30.6%) in the control group and 3 (8.57%) in the NPWT group (p = 0.020). Patients in the NPWT group had a significantly lower incidence of SSI (2 [5.71%] vs. 8 [22.2%] in the control group; p = 0.046) as well as significantly shorter median CWH (7 [7-7] days vs. 7 [7-15.5] days, p = 0.030). There was no difference in median LOS between groups (3 [2.5-5] days in the control group vs. 4 [2-4] days in the NPWT group; p = 0.072). CONCLUSIONS: Prophylactic postoperative NPWT after diverting ileostomy closure in colorectal cancer patients reduces the incidence of WRC and SSI. CLINICAL TRIAL REGISTRATION: clinicaltrials.gov (NCT04088162).