Loading clinical trials...
Loading clinical trials...
Poly-4-hydroxybutyrate Mesh Versus Current Care of Complex Open Ventral Hernias: A Multi-Center Randomized Controlled Trial
The purpose of this study is to compare clinical and patient centered outcomes of biosynthetic poly-4-hydroybutyrate meshes versus current care (synthetic polypropylene mesh or suture) for complex ventral hernia repair. The primary outcome for this study will be patients who are major complication free at 2 years postoperative. This will be a composite of hernia recurrence, reoperation, chronic wound complication, or death. Secondary outcomes include: surgical site occurences such as surgical site infection, seroma, hematoma and skin dehiscence within 90 days postoperative, emergency room visits withing 90 days postoperative, days in hospital up to 90 days postoperative, abdominal pain, and change in patient centered outcomes measured through the modified activities assessment scale (mAAS).
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Lyndon B. Johnson General Hospital
Houston, Texas, United States
Memorial Hermann Hospital-Texas Medical Center
Houston, Texas, United States
Start Date
April 1, 2021
Primary Completion Date
April 1, 2021
Completion Date
April 1, 2021
Last Updated
June 22, 2023
Repair of ventral hernia using biologic mesh
PROCEDURE
Repair of ventral hernia using suture repair or synthetic mesh
PROCEDURE
Lead Sponsor
The University of Texas Health Science Center, Houston
NCT07451483
NCT07422584
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05142618