Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02348034
Recruitment Status : Recruiting
First Posted : January 28, 2015
Last Update Posted : November 21, 2017
Sponsor:
Collaborators:
Kinetic Concepts, Inc.
Saskatoon Health Region
Information provided by (Responsible Party):
Gary Groot, University of Saskatchewan

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.

Condition or disease Intervention/treatment Phase
Surgical Wound Infection Device: Prevena Dressing Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 398 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Randomized Controlled Trial Exploring the Ability of Negative Pressure Wound Therapy (NPWT) to Reduce Colorectal Surgical Site Infections (SSI)
Actual Study Start Date : November 2015
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Presence/Absence of intervention related side effects [ Time Frame: Postoperative day 30. ]
    The secondary outcome will be any side effects related to the intervention.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02348034


Contacts
Layout table for location contacts
Contact: Gary Groot 306-227-8675 gag511@mail.usask.ca
Contact: Shrijal Bhavsar 306-381-9636 Shrijal.Bhavsar@usask.ca

Locations
Layout table for location information
Canada, Saskatchewan
St. Paul's Hospital Recruiting
Saskatoon, Saskatchewan, Canada, S7M 0Z9
Contact: Gary Groot    (306) 653-3366    gag511@mail.usask.ca   
Contact: Shrijal Bhavsar    (306) 381-9636    Shrijal.Bhavsar@usask.ca   
Principal Investigator: Gary Groot         
Royal University Hospital Recruiting
Saskatoon, Saskatchewan, Canada, S7N 0W8
Contact: Gary Groot    (306) 653-3366    gag511@mail.usask.ca   
Contact: Shrijal Bhavsar    (306) 381-9636    Shrijal.Bhavsar@usask.ca   
Principal Investigator: Gary Groot         
Sponsors and Collaborators
University of Saskatchewan
Kinetic Concepts, Inc.
Saskatoon Health Region
Investigators
Layout table for investigator information
Principal Investigator: Gary Groot University of Saskatchewan

Publications:
Measures displayed on Hospital Compare. 2013. Available at: http://www.medicare.gov/hospitalcompare/ Data/Measures-Displayed.html. Accessed March 22, 2013
Measures displayed on Hospital Compare. 2013. Available at: ttp://www.medicare.gov/hospitalcompare /Data/Measures-Displayed.html. Accessed March 22, 2013.
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
Surgical Site Infection (SSI) Event. Centers for Disease Control, 2015

Layout table for additonal information
Responsible Party: Gary Groot, M.D., University of Saskatchewan
ClinicalTrials.gov Identifier: NCT02348034     History of Changes
Other Study ID Numbers: 14-259
First Posted: January 28, 2015    Key Record Dates
Last Update Posted: November 21, 2017
Last Verified: November 2017

Keywords provided by Gary Groot, University of Saskatchewan:
Surgical Site Infection (SSI)
Negative Pressure Wound Therapy (NPWT)

Additional relevant MeSH terms:
Layout table for MeSH terms
Infection
Communicable Diseases
Wounds and Injuries
Surgical Wound Infection
Wound Infection
Surgical Wound
Postoperative Complications
Pathologic Processes