Negative Pressure Wound Therapy Use to Decrease Surgical Nosocomial Events in Colorectal Resections

NACompletedINTERVENTIONAL
Enrollment

300

Participants

Timeline

Start Date

January 1, 2015

Primary Completion Date

March 6, 2017

Study Completion Date

September 1, 2017

Conditions
Postoperative Surgical Site Infections
Interventions
DEVICE

Negative Pressure Wound Therapy

Prevena™ Incision Management System (PIMS) (Kinetic Concepts Inc. (KCI), San Antonio, TX) is an incisional vacuum assisted closure (PIMS) device intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy The PIMS applies continuous pressure to the closed surgical site at 125 mm Hg and is attached to a 45 mL canister for collection of exudate.

OTHER

Usual Care of Surgical Wound

Patients will receive pre-operative antibiotics consisting of 1g cefazolin (or in the case of an allergy, an alternative e.g. ciprofloxacin/vancomycin) and 500 mg metronidazole given intravenously within the 30 minute prior to beginning the operative procedure. In cases extending \> 4 hours, a second dose of each of the antibiotics will be administered. Hair at the operative site will be removed, if required, immediately prior to the skin incision using electric clippers. The abdomen will be prepped using 2% Chlorhexidiene solution (or 10% povidone if allergic). After closure of the skin, the surgical wound will be covered with a sterile adhesive dressing (Tegaderm), which will remain in place until the morning of post-operative day (POD)#2, unless saturated, in which case it is standard practice to change the dressing if the physician is in agreement. On POD#2, the surgical team will remove the initial dressing and daily dressing changes with standard gauze will be initiated.

Trial Locations (2)

N6A 5A5

London Health Sciences Centre - University Campus, London

N6A 5W9

London Health Sciences Centre - Victoria Campus, London

All Listed Sponsors
collaborator

Kinetic Concepts, Inc.

INDUSTRY

lead

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

NCT02007018 - Negative Pressure Wound Therapy Use to Decrease Surgical Nosocomial Events in Colorectal Resections | Biotech Hunter | Biotech Hunter