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

October 17, 2018 updated by: Lawson Health Research Institute
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.

Study Overview

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • London Health Sciences Centre - University Campus
      • London, Ontario, Canada, N6A 5W9
        • London Health Sciences Centre - Victoria Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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)
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Surgical Site Infection (SSI)
Time Frame: 30 days following operation

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
30 days following operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Need for Home Nursing Care (Home Care) related to Surgical Site Infection (SSI)
Time Frame: Up to 60 days post-operatively to encompass the treatment period required for the 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.
Up to 60 days post-operatively to encompass the treatment period required for the SSI.
Length of Stay in Hospital
Time Frame: Up to 60 days post-operatively to encompass the prolonged stay in hospital of some patients
Time from surgery to discharge from hospital.
Up to 60 days post-operatively to encompass the prolonged stay in hospital of some patients
Cost of Management of Surgical Site Infection (SSI)
Time Frame: Up to 60 days post-operatively to include the treatment period encompassed in the outpatient setting
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.
Up to 60 days post-operatively to include the treatment period encompassed in the outpatient setting
Number of Return Visits Related to Surgical Site Infection
Time Frame: Up to 60 days post-operatively to include the treatment period encompassed in the outpatient setting
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
Up to 60 days post-operatively to include the treatment period encompassed in the outpatient setting

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Potential Harm from PIMS therapy
Time Frame: Within the first 30 post-operative days
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.
Within the first 30 post-operative days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Michael Ott, MD, MSc, FRCSC, FACS, FASCRS, Division of General Surgery, Western University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2015

Primary Completion (ACTUAL)

March 6, 2017

Study Completion (ACTUAL)

September 1, 2017

Study Registration Dates

First Submitted

December 5, 2013

First Submitted That Met QC Criteria

December 9, 2013

First Posted (ESTIMATE)

December 10, 2013

Study Record Updates

Last Update Posted (ACTUAL)

October 19, 2018

Last Update Submitted That Met QC Criteria

October 17, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Postoperative Surgical Site Infections

Clinical Trials on Negative Pressure Wound Therapy

3
Subscribe