An interventional study of Repair of ventral hernia using biologic mesh and Repair of ventral hernia using suture repair or synthetic mesh in Ventral Hernia, sponsored by The University of Texas Health Science Center, Houston. Withdrawn at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-22.
Sponsored by The University of Texas Health Science Center, Houston · Not applicable, Interventional, and Treatment
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).
1,096 studies on the registry are indexed under Hernia; 132 are open to participants now.
Browse Hernia studies →The University of Texas Health Science Center, Houston is the lead sponsor of 880 studies on the registry; 209 are open to participants now.
Of its 170 completed or terminated interventional studies of FDA-regulated products, 140 (82%) have results posted.
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Exclusion Criteria:
Phasix mesh will be used in the repair of the hernia
Procedure: Repair of ventral hernia using biologic mesh
The hernia will be repaired with either synthetic mesh or suture repair, as determined by the operating surgeon.
Procedure: Repair of ventral hernia using suture repair or synthetic mesh
Ventral hernia will be repaired using biologic mesh
Ventral hernia will be repaired using the current treatment methods
Major complication free
A composite of hernia recurrence, reoperation, chronic wound complication, or death
Time frame: 2 years post-operative
Surgical site occurrences
Surgical site infection, seroma, hematoma, and skin dehiscence
Time frame: 90 days post-operative
Clavien-Dindo complication grade
Clavien-Dindo complication grade
Time frame: 90 days post-operative
Hospital duration
Days in hospital composed of post-operative length of stay and readmissions
Time frame: 90 days post-operative
Emergency room visits
Number of times ER was visited
Time frame: 90 days post-operative
Cost Analysis
Analysis of costs as performed from the healthcare perspective
Time frame: 2 years
Post-operative abdominal pain
Measured by the visual analogue scale (VAS)
Time frame: Day of consent and post-operatively at 1 month, 1 year and 2 years
Patient centered outcomes
Abdominal wall health status (AW-HS) measured through the modified activities assessment scale (mAAS)
Time frame: Day of consent and post-operatively at 1 month, 1 year and 2 years
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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The University of Texas Health Science Center, Houston