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

NCT02348034 | Completed DMC

• 1 other identifier: 14-259
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Surgical Wound Infection

Keywords

Surgical Site Infection (SSI); Negative Pressure Wound Therapy (NPWT)

Outcome Measures

Primary Outcomes (1)

• Presence/Absence of superficial surgical site infection

  Primary outcome of interest will be the presence and/or absence of superficial surgical site infection at postoperative day 30.

  Postoperative day 30.

Secondary Outcomes (1)

• Presence/Absence of intervention related side effects

  Postoperative day 30.

Study Arms (2)

Prevena Dressing

EXPERIMENTAL

This group will receive prevena dressing after the elective colorectal surgery

Device: Prevena Dressing

Conventional dressing

NO INTERVENTION

This group will receive conventional dressing after the elective colorectal surgery

Interventions

Prevena Dressing DEVICE

Prevena dressing will be applied to the closed surgical wound after the elective colorectal surgery to evaluate its ability to reduce surgical site infections.

Prevena Dressing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age equal or greater than 18 years
• 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
• Class II surgical wound
• Laparoscopically assisted colorectal procedure

You may not qualify if:

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

Sponsors & Collaborators

• University of Saskatchewan: lead
• Kinetic Concepts, Inc.: collaborator
• Saskatoon Health Region: collaborator

Study Sites (3)

St. Paul's Hospital, 1081 Burrard Street, C310

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

St. Paul's Hospital

Saskatoon, Saskatchewan, S7M 0Z9, Canada

Location

Royal University Hospital

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

Related Publications (35)

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  BACKGROUND

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• Guidance for Industry. Chronic Cutaneous Ulcer and Burn Wounds-Developing Products for Treatment (Draft Guidance). Rockville,MD, U.S. Department of Health and Human Services, 2000, p. 15

  BACKGROUND

• Surgical Site Infection (SSI) Event. Centers for Disease Control, 2015

  BACKGROUND

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gary Groot

  University of Saskatchewan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: January 22, 2015
• First Posted: January 28, 2015
• Study Start: November 1, 2015
• Primary Completion: December 7, 2020
• Study Completion: December 7, 2020
• Last Updated: April 28, 2021

Record last verified: 2021-04

Locations

CA (3)