Negative pressure wound therapy use to decrease surgical nosocomial events in colorectal resections (NEPTUNE): study protocol for a randomized controlled trial

• Published in: Current controlled trials in cardiovascular medicine Vol. 16; no. 1; p. 322
• Main Authors: Chadi, Sami A, Vogt, Kelly N, Knowles, Sarah, Murphy, Patrick B, Van Koughnett, Julie Ann, Brackstone, Muriel, Ott, Michael C
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 30.07.2015; BioMed Central
• Subjects: Adhesives; Analysis; Antibiotics; Clinical Protocols; Clinical trials; Colon - surgery; Colorectal surgery; Cross Infection - diagnosis; Cross Infection - economics; Cross Infection - microbiology; Cross Infection - prevention & control; Digestive System Surgical Procedures - adverse effects; Digestive System Surgical Procedures - economics; Health aspects; Home Care Services; Hospital Costs; Hospitals; Humans; Infection; Infection control; Intention to Treat Analysis; Intervention; Laparoscopy; Laparotomy; Length of Stay; Medical equipment and supplies industry; Medical test kit industry; Morbidity; Negative-Pressure Wound Therapy - adverse effects; Negative-Pressure Wound Therapy - economics; Nosocomial infections; Ontario; Orthopedics; Patient Readmission; Patients; Pregnant women; Prospective Studies; Recovery (Medical); Rectum - surgery; Research Design; Risk Factors; Study Protocol; Surgery; Surgical Wound Infection - diagnosis; Surgical Wound Infection - economics; Surgical Wound Infection - microbiology; Surgical Wound Infection - prevention & control; Time Factors; Trauma; Treatment Outcome; Wound healing; Ontario; United States; United States > US
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-015-0817-8

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. 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. 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. NCT02007018--clinicaltrials.gov; 5 December 2013.