Abstract
BACKGROUND: Surgical site infections (SSIs) are the second most common form of nosocomial infection. Colorectal resections have high rates of SSIs secondary to the inherently contaminated intraluminal environment. Negative pressure wound therapy dressings have been used on primarily closed incisions to reduce surgical site infections in other surgical disciplines. No randomized control trials exist to support the use of negative pressure wound therapy following elective open colorectal resection to reduce surgical site infection. METHODS/DESIGN: In this single-center, superiority designed prospective randomized open blinded endpoint controlled trial, patients scheduled for a colorectal resection via a laparotomy will be considered eligible. Patients undergoing laparoscopic resection will be enrolled but only randomized and included if the operation is converted to an open procedure. Exclusion criteria are patients receiving an abdominoperineal resection or a palliative procedure, as well as pregnant patients and those with an adhesive allergy. After informed consent, 300 patients will be randomized to the use of a standard adhesive gauze dressing or to a negative pressure wound device. Patients will be followed in hospital and reassessed on post-operative day 30. The primary outcome measure is SSI within the first 30 post-operative days. Secondary outcomes include the length of hospital stay, the number of return visits related to a potential or actual SSI, cost, and the need for homecare. The primary endpoint analysis follows the intention-to-treat principle. DISCUSSION: NEPTUNE is the first randomized controlled trial to investigate the role of incisional negative pressure wound therapy in decreasing the rates of surgical site infections in the abdominal incisions of patients following an elective, open colorectal resection. This low-risk intervention may help decrease the morbidity and costs associated with the development of an SSI in our patients. TRIAL REGISTRATION: NCT02007018--clinicaltrials.gov; 5 December 2013.