Effect of Duramesh™ on Hernia Formation After Ileostomy Closure, Randomized Controlled Trial
NCT ID: NCT06511414
Last Updated: 2024-07-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
106 participants
INTERVENTIONAL
2024-01-03
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Duramesh
using duramesh suture for ileostomy fascial closure
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
Control
standard ileostomy fascial closure
Control
standard closure of fascia
Interventions
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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
Control
standard closure of fascia
Eligibility Criteria
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Inclusion Criteria
* Age 18 or greater
* Surgical oncology patient where routine radiologic surveillance for malignancy is planned
* Patient accepts participation and gives informed consent
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Northwestern University
OTHER
Responsible Party
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Vitaliy Poylin
Director, Section of Colon and Rectal Surgery
Locations
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Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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STU00220106
Identifier Type: -
Identifier Source: org_study_id
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