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

EXPERIMENTAL: Negative Pressure Wound Therapy

This group will receive the usual care of surgical wound AND Negative Pressure Wound Therapy (NPWT). The Prevena™ Incision Management System (PIMS) is placed in a sterile fashion over the closed surgical site prior to leaving the operating room. The PIMS is to remain in place until the completion of therapy at five days.

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 Names:

• Prevena™ Incision Management System (PIMS) (Kinetic Concepts Inc. (KCI)

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.

ACTIVE_COMPARATOR: Usual Care of Surgical Wound

This group will receive the usual care of a surgical wound.

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.

Postoperative Surgical Site Infection (SSI)

Postoperative surgical site infection (SSI), as defined by the following CDC (Centre for Disease Control) criteria:

Infection occurring within the first 30 post-operative days with at least one of the following:

1. Purulent drainage from the incision
2. Organisms isolated from an aseptically obtained culture of fluid or tissue from the incision

3. At least one of the following signs/symptoms of infection

   • Pain or tenderness
   • Localized swelling
   • Redness
   • Heat AND incision is deliberately opened by a surgeon (unless incision is culture negative)
4. Diagnosis of SSI by the surgeon or attending physician

Need for Home Nursing Care (Home Care) related to Surgical Site Infection (SSI)

The need for home care will be determined by the surgical team after the identification of an SSI, and will be recorded by the study team. The duration of home care requirements will be determined at the time of post-operative clinic visits, as the home care process requires ongoing written communication with the surgeon for the duration of therapy, and this communication is concurrently occurring at the time of clinic visits.

Length of Stay in Hospital

Time from surgery to discharge from hospital.

Cost of Management of Surgical Site Infection (SSI)

The cost of each SSI will be determined using the hospital case-costing dataset for inpatient care, clinic visits, and emergency department visits, and the standardized time and materials costs available from the Community Care Access Centre for home care.

Number of Return Visits Related to Surgical Site Infection

A return visit related to SSI will include any visit to the emergency department, outpatient surgical clinic, or requirement for admission to hospital that is deemed by the primary surgeon or study team to be due to a) signs or symptoms of SSI requiring assessment; b) development of an SSI requiring management; or c) ongoing care of a known SSI

Potential Harm from PIMS therapy

Allergy/sensitivity or local cutaneous reaction to PIMS or components will be defined as erythema, rash, pruritis, urticaria, contusion, maceration, first degree burn (if device gets too warm) or any other concerning skin changes at the surgical site determined by the primary surgeon NOT to be related to the surgery or a SSI. We will also be looking for unforeseen potential sources of harm that although very unlikely, have never been demonstrated with the use of this device.