An international pragmatic randomized controlled trial to compare a single-use negative-pressure dressing versus the surgeon's preference of dressing to reduce the incidence of surgical site infection following emergency laparotomy: the SUNRRISE trial protocol

Abstract

Background: Surgical site infection (SSI) is a common complication following emergency laparotomy occurring in around 25% of patients in UK practice. The use of single use negative pressure dressings (SUNPDs) for these wounds has been proposed as a prophylactic method of reducing the rate of SSI. Method: The Single Use Negative pRessure dressing for Reduction In Surgical site infection following Emergency laparotomy (SUNRRISE) study is an international, multicentre, pragmatic, phase III randomised controlled trial (RCT) with internal feasibility phase. The primary aim is to determine if a single use negative pressure dressing (SUNPD) reduces surgical site infection (SSI) at 30 days post-operatively. Patients will be randomised in a 1:1 ratio to either a SUNPD or to receive a dressing of the surgeon's preference. Outcome assessors will be blinded to treatment allocation. The primary outcome measure is SSI within 30 days of surgery as defined by the Centers for Disease Control criteria. A total of 840 patients will be required to detect a relative reduction of 40% in SSI rates (from 25% to 15%) with 90% power accounting for 20% attrition rate. Discussion: SUNRRISE is an international, multicentre RCT evaluating the prophylactic use of SUNPD in primary closed emergency laparotomy wounds for the reduction of SSI. Our hypothesis is that a SUNPD is superior to the surgeon's preference of dressing in reducing surgical site infections at 30 days. These findings may influence dressing choice following emergency abdominal surgery in the future.