Phasix Mesh Use in Complex Open Ventral Hernias Study

Study Overview
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Brief Summary
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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).

Official Title
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Poly-4-hydroxybutyrate Mesh Versus Current Care of Complex Open Ventral Hernias: A Multi-Center Randomized Controlled Trial

Conditions
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Ventral Hernia

Intervention / Treatment
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* Procedure: Repair of ventral hernia using biologic mesh
* Procedure: Repair of ventral hernia using suture repair or synthetic mesh


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Phasix Mesh<br>Phasix mesh will be used in the repair of the hernia | Procedure: Repair of ventral hernia using biologic mesh<br>* Ventral hernia will be repaired using biologic mesh<br>|
| Active Comparator: Current Care<br>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<br>* Ventral hernia will be repaired using the current treatment methods<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major complication free | A composite of hernia recurrence, reoperation, chronic wound complication, or death | 2 years post-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical site occurrences | Surgical site infection, seroma, hematoma, and skin dehiscence | 90 days post-operative | 
| Clavien-Dindo complication grade | Clavien-Dindo complication grade | 90 days post-operative | 
| Hospital duration | Days in hospital composed of post-operative length of stay and readmissions | 90 days post-operative | 
| Emergency room visits | Number of times ER was visited | 90 days post-operative | 
| Cost Analysis | Analysis of costs as performed from the healthcare perspective | 2 years | 
| Post-operative abdominal pain | Measured by the visual analogue scale (VAS) | 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) | Day of consent and post-operatively at 1 month, 1 year and 2 years |