Phasix Mesh Use in Complex Open Ventral Hernias Study

Not Applicable

Withdrawn

• Conditions: Ventral Hernia
• Interventions: Procedure: Repair of ventral hernia using biologic mesh; Procedure: Repair of ventral hernia using suture repair or synthetic mesh

• Registration Number: NCT04580524
• Lead Sponsor: The University of Texas Health Science Center, Houston

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-02
• Study First Submitted QC: 2020-10-02
• Study First Posted: 2020-10-08
• Study Start: 2021-04
• Primary Completion: 2021-04
• Study Completion: 2021-04
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-20
• Last Update Posted: 2023-06-22

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Adult patients (18 years or older) with a complex ventral hernia scheduled for repair

Exclusion Criteria

• Patients likely to die within 3 years (cirrhosis, terminal cancer, surgeon judgement)
• Unlikely to follow-up (live out of state, unable to be reached by phone or email)
• Non-English and non-Spanish speakers
• Pregnant or breast-feeding patients
• Allergies/hypersensitivities to tetracycline hydrochloride and kanamycin sulfate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Phasix Mesh	Repair of ventral hernia using biologic mesh	Phasix mesh will be used in the repair of the hernia
Current Care	Repair of ventral hernia using suture repair or synthetic mesh	The hernia will be repaired with either synthetic mesh or suture repair, as determined by the operating surgeon.

Primary Outcome Measures

Name	Time	Method
Major complication free	2 years post-operative	A composite of hernia recurrence, reoperation, chronic wound complication, or death

Secondary Outcome Measures

Name	Time	Method
Surgical site occurrences	90 days post-operative	Surgical site infection, seroma, hematoma, and skin dehiscence
Hospital duration	90 days post-operative	Days in hospital composed of post-operative length of stay and readmissions
Post-operative abdominal pain	Day of consent and post-operatively at 1 month, 1 year and 2 years	Measured by the visual analogue scale (VAS)
Clavien-Dindo complication grade	90 days post-operative	Clavien-Dindo complication grade
Emergency room visits	90 days post-operative	Number of times ER was visited
Cost Analysis	2 years	Analysis of costs as performed from the healthcare perspective
Patient centered outcomes	Day of consent and post-operatively at 1 month, 1 year and 2 years	Abdominal wall health status (AW-HS) measured through the modified activities assessment scale (mAAS)

Trial Locations

Locations (2)

Lyndon B. Johnson General Hospital; 🇺🇸 Houston, Texas, United States

Memorial Hermann Hospital-Texas Medical Center; 🇺🇸 Houston, Texas, United States