Prophylactic NPWT to Reduce SSI in Colorectal Surgery

November 19, 2020 updated by: joel bauer, Icahn School of Medicine at Mount Sinai

Prophylactic Negative Pressure Wound Therapy to Reduce Surgical Site Infections in Elective Clean-Contaminated Colon Resections

The purpose of this study is to see if the Negative Pressure Wound Therapy (NPWT) system is effective and safe for the prevention of superficial and deep incisional surgical site infections (SSI) in high risk patients within 30 days after elective colorectal surgery. It has been shown that patients with an IBD, patients undergoing a reoperation or patients with certain comorbidities are at a higher risk of developing an SSI. The NPWT device is a wound dressing with a vacuum system that can be placed over abdominal wounds. The study will include up to 400 patients at this single site, where these high risk patients will be randomized to receive either one of two arms. The first arm involves the placement of the NPWT device in the immediate postoperative period over abdominal wounds after clean/contaminated colorectal surgical procedures. The device would then be left on for 5 days. The second arm would be standard of care and would entail routine postoperative protocols. Subjects will then be seen once at a 30 day (± 7 days) follow-up visit to assess for the development of SSIs.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

7

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

  • United States
    • New York
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai

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 to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ages 18-80
  • patients who will undergo an open or laparoscopic-assisted clean/contaminated colorectal surgical procedure.
  • Patients must either have an inflammatory bowel disease, undergoing reoperation within 30 days, or have two or more of the following risk factors: presence of an ostomy, type II diabetes, BMI greater than 30, immunosuppression, malnutrition, current smoker, chronic kidney disease (creatinine > 1.2), and disseminated cancer.

Exclusion Criteria:

  • patients currently enrolled in another interventional clinical trial,
  • patients with a BMI less than 20, patients with a current abdominal abscess or infection (including a known urinary tract infection),
  • patients allergic to or hypersensitive to silver, patients planning to undergo a second colorectal surgical procedure (e.g., colostomy or ileostomy takedown) or any other general surgery in less than 30 days of index-surgery,
  • any patient in which the planned surgery would include: i) placement of a stoma in the principal incision; ii) placement of a drain into the supra-peritoneal fascia space that emerges through the principal incision; iv) placement of a drain into the intraperitoneal space that emerges through the principal incision; and v) supplementation of any of the irrigation fluid with antibiotic or antiseptic drugs,
  • patients with healing disorders,
  • pregnant women,
  • prisoners, or
  • any patient that is deemed unsuitable for the study by the Principal Investigator or the operating surgeon/Co-Investigator.

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
This group will receive the negative pressure wound therapy device.
Device: Prevena
The NPWT device is a wound dressing with a vacuum system that can be placed over abdominal wounds, placed in the immediate postoperative period over abdominal wounds after clean/contaminated colorectal surgical procedures.
Other Names:
  • Negative pressure wound therapy device
No Intervention: Standard of Care
This group will not receive the device and their surgery and clinical course will proceed as if they were not part of the study. They will receive the standard of care wound dressings.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Surgical Site Infection
Time Frame: 37 days
Any type of Surgical site infection as defined by the CDC developed within the follow-up period.
37 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of Hospital Stay
Time Frame: average of 7 days
average of 7 days
Number of Serious Adverse Events
Time Frame: up to 37 days
Number of serious adverse events developed within the follow-up period
up to 37 days

Collaborators and Investigators

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

Sponsor

Icahn School of Medicine at Mount Sinai

Collaborators

Kinetic Concepts, Inc.

Investigators

  • Principal Investigator: Joel Bauer, MD, Icahn School of Medicine at Mount Sinai

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)

August 13, 2018

Primary Completion (Actual)

January 28, 2019

Study Completion (Actual)

January 28, 2019

Study Registration Dates

First Submitted

September 5, 2018

First Submitted That Met QC Criteria

September 5, 2018

First Posted (Actual)

September 7, 2018

Study Record Updates

Last Update Posted (Actual)

December 17, 2020

Last Update Submitted That Met QC Criteria

November 19, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCO 18-0703

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

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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