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NCT06511414 · ClinicalTrials.gov registry record · NA
Effect of Duramesh™ on Hernia Formation After Ileostomy Closure, Randomized Controlled Trial
A NA study of Incisional Hernia and Ileostomy - Stoma, sponsored by Northwestern University.
- Recruiting
- Registry status
- NA
- Development phase
- 106
- Enrollment target
- 1
- Study location
NCT06511414: Recruiting NA study of Incisional Hernia and Ileostomy - Stoma, sponsored by Northwestern University.
NCT06511414 is a NA study of Incisional Hernia and Ileostomy - Stoma that is actively recruiting participants, run by Northwestern University. The registered enrollment target is 106 participants, below the 302-participant average among 5 other Incisional Hernia trials with a reported enrollment target (65% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06511414, a NA study of Incisional Hernia and Ileostomy - Stoma, is actively recruiting participants, sponsored by Northwestern University.
- RECRUITING
- Registry status
- NA
- Development phase
- 106 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
Compare hernia rates after ileostomy closure between Duramesh™ and standard monofilament closure
Conditions Studied
Interventions
- DEVICE duramesh
- DEVICE Control
Study Locations (1)
Illinois
- Northwestern University Feinberg School of Medicine - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 106 participants |
| Start Date | 2024-01-03 |
| Est. Completion | 2026-12 |
| Phase | NA |
What NCT06511414 shows while recruiting
NCT06511414 is an interventional study that assigns participants to a tested intervention. The registered 106 participants enrollment target is mid-sized for trials with a published cap, below the 302-participant average among 5 other Incisional Hernia trials with a reported enrollment target (65% lower).
The record links to 2 conditions, with Incisional Hernia appearing as the primary indexed condition, and to 2 interventions - of which duramesh is the first listed.
NCT06511414 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT06511414 about?
NCT06511414 is a clinical study titled "Effect of Duramesh™ on Hernia Formation After Ileostomy Closure, Randomized Controlled Trial". 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 a...
What is the current status of trial NCT06511414?
This trial is currently recruiting. It is a NA study. The enrollment target is 106 participants. The study started on 2024-01-03. Estimated completion is 2026-12.
What conditions does trial NCT06511414 study?
This clinical trial studies the following conditions: Incisional Hernia, Ileostomy - Stoma.
What interventions are being tested in trial NCT06511414?
The interventions under investigation include: duramesh (DEVICE), Control (DEVICE).
Who is sponsoring clinical trial NCT06511414?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06511414 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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