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

Lawson Health Research Institute

Status: Completed

Conditions: Postoperative Surgical Site Infections

Treatments: Other: Usual Care of Surgical Wound; Device: Negative Pressure Wound Therapy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02007018

NEPTUNE

Details and patient eligibility

About

The purpose of this study is to determine, in patients who undergo an elective colorectal resection through a midline laparotomy incision, whether the use of negative pressure wound therapy (NPWT) applied to the site of the laparotomy compared to standard care alone, reduces the incidence of surgical site infection (SSI) in the first 30 days postoperatively. The investigators hypothesize that the use of NPWT will reduce the rate of postoperative SSI, as well as decrease the need for Nursing Home Care for SSI, length of hospital stay and return visits related to SSI.

Full description

The proposed trial will be pragmatic in nature whereby the investigators are trying to simulate usual circumstances to inform their everyday clinical decisions on the utility of negative pressure wound therapy (NPWT). A prospective randomized open label blind endpoint (PROBE) trial design was chosen. All patients scheduled to undergo elective colorectal resections (CRR) at London Health Sciences Centre (LHSC) will be identified at the time of a pre-operative clinic visit with one of the 13 surgeons performing CRR at their institution. Included patients will be randomized to receive either usual care or usual care plus NPWT. All patients will be followed for 30 post-operative days to identify the development of an SSI and other secondary outcomes. Given the nature of the intervention, the surgeon and patients cannot be blinded to the intervention. Outcome assessors and statisticians will be blinded to the patient's allocated group.

Enrollment: 300 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years
• Planned elective colorectal resection (those that occur as a scheduled operation in the surgeons' planned operative list)

Exclusion criteria

• Palliative colorectal resection where predicted remaining lifespan is likely less than 30 days
• Abdominoperineal resection or pelvic exenteration
• Known allergy/sensitivity to adhesive
• Cases in which there is a suspicion of bowel perforation
• Pregnancy

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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300 participants in 2 patient groups

Negative Pressure Wound Therapy

Experimental group

Description:

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.

Treatment:

Device: Negative Pressure Wound Therapy

Other: Usual Care of Surgical Wound

Usual Care of Surgical Wound

Active Comparator group

Description:

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

Treatment:

Other: Usual Care of Surgical Wound