Effect of Duramesh™ on Hernia Formation After Ileostomy Closure

May 22, 2026 updated by: Vitaliy Poylin, Northwestern University
Diverting ileostomy is frequently utilized to protect high-risk anastomoses, though it is not shown to reduce the leak rate it may reduce the severe consequences of an anastomotic leak. Ileostomy will be reversed with restoration of continuity in majority of patients. Stoma site incisional hernias after ileostomy closure are complex hernias that can be associated with abdominal pain, discomfort, and a diminished quality of life. Duramesh™ non-absorbable polypropylene suture is a hollow core, microporous, cylindrical suture made off in polypropylene filaments that are loosely braided and bonded to each other with heat and pressure. The Aim of this study is to evaluate Duramesh™ suture vs standard closure on rates of hernia formation after ileostomy closure.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

106

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
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University Feinberg School of Medicine

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • • Patients undergoing ileostomy closure after surgery for cancer All patients with a stoma (independent of diagnosis)

    • Age 18 or greater
    • Surgical oncology patient where routine radiologic surveillance for malignancy is planned
    • Patient accepts participation and gives informed consent

Exclusion Criteria:

  • • Pregnancy

    • Prior mesh hernia repair at laparotomy site
    • Life expectancy less than 1 years
    • Patient is unable / unwilling to provide informed consent
    • Patient is unable to comply with the protocol or proposed follow-up visits
    • Patient is enrolled in another hernia study
    • Non-English-speaking participants
    • Data from children will not analyzed in this study.
    • Cognitively Impaired Adults: Data from cognitively impaired adults will not analyzed in this study.
    • Adults Unable to Consent: Data from adults unable to consent will not analyzed in this study.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Duramesh
using duramesh suture for ileostomy fascial closure
Device: duramesh
Duramesh™ non-absorbable polypropylene suture is a hollow core, microporous, cylindrical suture made off in polypropylene filaments that are loosely braided and bonded to each other with heat and pressure
Active Comparator: Control
standard ileostomy fascial closure
Device: Control
standard closure of fascia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hernia rates
Time Frame: 1 year
Compare hernia rates after ileostomy closure between Duramesh™ and standard monofilament closure
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
infection rate
Time Frame: 1 year
Evaluate potential side effects including infections and need for re intervention associated with Duramesh™ vs standard closure
1 year

Collaborators and Investigators

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

Sponsor

Northwestern University

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 3, 2024

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

July 16, 2024

First Submitted That Met QC Criteria

July 16, 2024

First Posted (Actual)

July 22, 2024

Study Record Updates

Last Update Posted (Actual)

May 27, 2026

Last Update Submitted That Met QC Criteria

May 22, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU00220106

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.

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.

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