A Randomized Controlled Trial Exploring the Ability of Negative Pressure Wound Therapy (NPWT) to Reduce Colorectal Surgical Site Infections (SSI)

April 26, 2021 updated by: Gary Groot, University of Saskatchewan
The study will explore the ability of negative pressure wound therapy (Prevena dressing) to reduce post operative superficial surgical site infection rate in elective colorectal surgery. Half of the participants will receive Prevena dressing on closed incision immediately after the operation while other half will receive conventional surgical dressing.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The trial will commence with recruitment of participants after an assessment of their potential eligibility. Those recruited in the trial will sign informed consent either on the day of surgery or during the PAC appointment, before any study-related activities are performed.

Perioperative measures will include bowel preparation with Fleet Phospho-soda, preoperative shaving with electric clippers 1 hour before the operation, and intravenous prophylactic antibiotic administered 30 minutes before the incision, and repeated in OR if the operation lasts more than 3 hours, and discontinued within 24 h after the operation. In all procedures, chlorhexidine solution will be applied to the skin to achieve preoperative skin antisepsis, and the usual reusable or disposable surgical gowns, drapes, and gloving will be used. The type of surgical procedure will be a colorectal resection for any malignant or benign condition of the colon, rectum or anal canal via a laparotomy wound. The type of incision will either be a vertical midline or transverse abdominal incision. Laparotomy wound will be closed primarily as a mass closure technique utilizing polydioxanone (PDS) or Nylon suture. Skin and subcutaneous tissues will be approximated using stainless-steel staples.

During the surgery, assessment of eligibility (including wound classification) will be completed, and if eligible, the participant will be randomized to one of the two treatment arms - group A (conventional dressing) or group B (Prevena dressing). The randomization scheme is described later in the protocol. After the surgical wound is closed, the assigned dressing - conventional dressing (Mepore) or Prevena dressing - will be applied.

For participants in group A (conventional dressing) the wound will be inspected on an as needed basis during postoperative days 1-6 to assess for SSI (where day 0 = day of surgery). On postoperative day 7, the dressing will be removed. If the participant is in hospital, the wound care nurse or study staff will remove the dressing and examine the wound for SSI. If the participant was discharged before postoperative day 7, the home care nurse or the participant's physician will remove the dressing. The patient will have been sent home with a Post-Op Day 7 follow-up form, and will have been instructed to provide the form to the home care nurse or their physician to complete for the assessment for SSI.

For participants randomized to group B (Prevena dressing), the wound care nurse or study staff will inspect the dressing daily during postoperative days 1-6 (where day 0 = day of surgery) to assess for proper functioning of the Prevena dressing. If the participant is discharged before postoperative day 7, the wound care nurse or study staff will contact the participant daily to check for proper functioning of the Prevena dressing. On postoperative day 7, the Prevena dressing will be removed. If the participant is in hospital, the wound care nurse or study staff (residents or Surgeons) will remove the dressing and assess the wound for SSI. If the participant was discharged before postoperative day 7, the home care nurse or the participant's physician will remove the dressing. The patient will have been sent home with a Post-Op Day 7 follow-up form, and will have been instructed to provide the form to the home care nurse or their physician to complete for signs of SSI.

If SSI is suspected, the participant will be advised to visit the clinic for assessment of SSI by the study team. In case it is not possible for the participant to visit the clinic for assessment of SSI by the study team, the participants will have been sent home with a SSI Confirmation form to be completed by the participant's physician.

The wound care nurse or study staff will conduct post-discharge follow-up on postoperative days 14 (± 2 days) and 21 (± 2 days) by telephoning the family physician or the participant to check whether there are signs of SSI. If SSI is suspected, the participant will be advised to visit the clinic for assessment of SSI by the study team. If not possible, the participant will be instructed to ask their physician to complete the SSI Confirmation form.

On postoperative day 30 (± 7 days), the participant will be seen in the clinic by the treating surgeon as a part of the treatment and follow-up plan, and the wound will be assessed for SSI. For participants who are not able to come to the clinic, the study team will contact the participant or the family physician by telephone to check whether there are signs of SSI. If SSI is suspected, the participant will be advised to visit the clinic for assessment of SSI by the study team. If not possible, the participant will be instructed to ask their physician to complete the SSI Confirmation form.

As described above, each participant will have up to 12 study visits (11 scheduled visits, including the day of surgery, plus one clinic visit if there is suspicion of SSI). At any point, however, once SSI is confirmed, the participant will undergo no further study visits.

Study Type

Interventional

Enrollment (Actual)

126

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

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • St. Paul's Hospital, 1081 Burrard Street, C310
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 0W8
        • Royal University Hospital
      • Saskatoon, Saskatchewan, Canada, S7M 0Z9
        • St. Paul's Hospital

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:

  1. Age equal or greater than 18 years
  2. Patient undergoing colorectal resective surgery for any reason (benign or malignant) such as diverticular disease, colorectal cancer or inflammatory bowel disease through a laparotomy wound
  3. Class II surgical wound
  4. Laparoscopically assisted colorectal procedure

Exclusion Criteria:

  1. Patient requires emergent or urgent operation
  2. Patient has advanced colorectal malignancy associated with peritoneal carcinomatosis
  3. Class III or IV surgical wound
  4. Laparoscopic surgery involving intracorporeal colorectal resection and anastomosis
  5. Patient has a previous disfigured midline laparotomy surgical scar requiring wide excision of skin, subcutaneous tissue, fascia and muscle

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Prevena Dressing
This group will receive prevena dressing after the elective colorectal surgery
Device: Prevena Dressing
Prevena dressing will be applied to the closed surgical wound after the elective colorectal surgery to evaluate its ability to reduce surgical site infections.
No Intervention: Conventional dressing
This group will receive conventional dressing after the elective colorectal surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence/Absence of superficial surgical site infection
Time Frame: Postoperative day 30.
Primary outcome of interest will be the presence and/or absence of superficial surgical site infection at postoperative day 30.
Postoperative day 30.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence/Absence of intervention related side effects
Time Frame: Postoperative day 30.
The secondary outcome will be any side effects related to the intervention.
Postoperative day 30.

Collaborators and Investigators

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

Sponsor

University of Saskatchewan

Collaborators

Kinetic Concepts, Inc.
Saskatoon Health Region

Investigators

  • Principal Investigator: Gary Groot, University of Saskatchewan

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.

General Publications

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)

November 1, 2015

Primary Completion (Actual)

December 7, 2020

Study Completion (Actual)

December 7, 2020

Study Registration Dates

First Submitted

January 22, 2015

First Submitted That Met QC Criteria

January 22, 2015

First Posted (Estimate)

January 28, 2015

Study Record Updates

Last Update Posted (Actual)

April 28, 2021

Last Update Submitted That Met QC Criteria

April 26, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-259

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.

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