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OpenTrials
Active, Not Recruiting

NCT Number: NCT06511414

Effect of Duramesh™ on Hernia Formation After Ileostomy Closure

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Incisional Hernia Hernia Ileostomy - Stoma Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

duramesh

Device

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

Control

Device

standard closure of fascia

Primary outcomes

  1. hernia rates

    Time frame: 1 year

    Compare hernia rates after ileostomy closure between Duramesh™ and standard monofilament closure

Secondary outcomes

  1. infection rate

    Time frame: 1 year

    Evaluate potential side effects including infections and need for re intervention associated with Duramesh™ vs standard closure

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 22, 2024
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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