Randomized Controlled Trial of Prophylactic Negative-Pressure Wound Therapy at Ostomy Closure for the Prevention of Delayed Wound Healing and Surgical Site Infection in Patients with Ulcerative Colitis.

Background/aims: Although negative-pressure wound therapy (NPWT) is likely advantageous for wound healing, the efficacy and safety of its prophylactic use remain unclear for digestive surgery. We performed a prospective randomized controlled study to evaluate the efficacy and safety of this procedure during ileostomy closure.

Methods: We conducted a prospective, randomized study between November 2014 and September 2015. Patients with ulcerative colitis scheduled to undergo ileostomy closure with purse-string suture (PSS) were randomly divided into groups with or without NPWT. The primary endpoint was complete wound healing. The secondary endpoints were incidences of wound complications.

Results: A total of 31 patients with PSS alone and 28 patients with PSS + NPWT were enrolled. Wound infection was observed in 1 patient in the PSS-alone condition and 3 patients in the PSS + NPWT condition (p = 0.76). The mean duration of complete wound healing was 37.6 ± 11.7 days in the PSS-alone condition and 33.5 ± 10.0 days in the PSS + NPWT condition (p = 0.18).

Conclusion: Although no adverse effects were observed in this series, the efficacy of PSS + NPWT was not confirmed. Further clarification of the indication of prophylactic NPWT and its efficacy must be obtained, and the efficacy and safety of NPWT in different dirty/infected surgeries should be evaluated.