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Suture

Duramesh™ for Hernia Prevention

N/A
Recruiting
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients undergoing ileostomy closure after surgery for cancer
All patients with a stoma (independent of diagnosis)
Must not have
Data from children will not be analyzed in this study
Prior mesh hernia repair at laparotomy site
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group

Summary

This trial is comparing two types of sutures to see which one is better at reducing hernia formation after closing an ileostomy. The ileostomy is a common procedure to protect high-risk surgical

Who is the study for?
This trial is for patients who have had an ileostomy, a type of surgery that creates an opening in the abdomen to divert waste. It's specifically for those facing stoma site incisional hernias after their ileostomies are closed. Participants should not currently have any other conditions that would interfere with the study.
What is being tested?
The study is testing whether using Duramesh™, a special non-absorbable suture material, can reduce the rate of hernia formation compared to standard suturing techniques after ileostomy closure. Patients will be randomly assigned to either receive Duramesh™ or standard closure.
What are the potential side effects?
Potential side effects may include typical surgical complications such as pain at the suture site, infection, inflammation, and allergic reactions specific to the materials used in Duramesh™.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am having my ileostomy closed after cancer surgery.
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I have a stoma.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am an adult participating in this study.
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I had a mesh repair for a hernia at my previous surgery site.
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I do not have cognitive impairment.
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I can follow the study plan and attend all appointments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
hernia rates
Secondary study objectives
infection rate

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: DurameshExperimental Treatment1 Intervention
using duramesh suture for ileostomy fascial closure
Group II: ControlActive Control1 Intervention
standard ileostomy fascial closure

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor
1,647 Previous Clinical Trials
958,546 Total Patients Enrolled
~58 spots leftby Dec 2025
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