Phasix Mesh Use in Complex Open Ventral Hernias Study

The University of Texas System (UT)

Status: Withdrawn

Conditions: Ventral Hernia

Treatments: Procedure: Repair of ventral hernia using suture repair or synthetic mesh; Procedure: Repair of ventral hernia using biologic mesh

Study type: Interventional

Funder types: Other

Identifiers

NCT04580524

HSC-MS-20-0655

Details and patient eligibility

About

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).

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups

Phasix Mesh

Active Comparator group

Description:

Phasix mesh will be used in the repair of the hernia

Treatment:

Procedure: Repair of ventral hernia using biologic mesh

Current Care

Active Comparator group

Description:

The hernia will be repaired with either synthetic mesh or suture repair, as determined by the operating surgeon.

Treatment:

Procedure: Repair of ventral hernia using suture repair or synthetic mesh