NCT06511414

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 106 (estimated)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Incisional Hernia
• Ileostomy - Stoma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-01-03
• Primary completion: 2025-12-01
• Completion: 2026-12-01
• First posted: 2024-07-22
• Last updated: 2024-07-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study