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RECRUITING
NCT06511414
NA

Effect of Duramesh™ on Hernia Formation After Ileostomy Closure, Randomized Controlled Trial

Sponsor: Northwestern University

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

106

Start Date

2024-01-03

Completion Date

2026-12

Last Updated

2024-07-22

Healthy Volunteers

No

Interventions

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

DEVICE

Control

standard closure of fascia

Locations (1)

Northwestern University Feinberg School of Medicine

Chicago, Illinois, United States