Post-market Study of the Biodesign Hernia Graft

Study Overview
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Brief Summary
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The purpose of this study is to collect data on the performance of the Biodesign® Hernia Graft when used to reinforce soft tissues during ventral hernia repair.

Detailed Description
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This multicenter, open-label, prospective clinical study will evaluate the performance of the Biodesign Hernia Graft to reinforce soft tissues during ventral hernia repair. This post-market study will enroll up to 95 patients at up to 10 clinical sites. Each clinical site will be limited to a maximum of 50 patients to ensure a variety of patients and surgical techniques are represented. There is no minimum enrollment number per site. This study has been designed as a multicenter, open-label, prospective study to collect data on the performance of the Biodesign Hernia Graft. The inclusion and exclusion criteria for this study have been selected based on the instructions outlined in the IFU so that the results from this study can provide data on the real-world use of the device.

Official Title
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Post-market Study of the Biodesign® Hernia Graft

Conditions
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Ventral Hernia

Intervention / Treatment
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* Device: Biodesign Hernia Graft


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Primary or recurrent ventral hernia in need of surgical repair utilizing a Biodesign Hernia Graft Exclusion Criteria: Known sensitivity to porcine material For the study, the following patients will also be excluded: Age < 18 years Unable or unwilling to provide informed consent Life expectancy of less than one year from the date of the index procedure Patients will be excluded from the study if they never receive a Biodesign Hernia Graft during their index procedure.

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Biodesign Hernia Graft|The Biodesign Hernia Graft is comprised of 8 layers of decellularized porcine small intestinal submucosa (SIS) that has been pressed-lyophilized (i.e., freeze-dried under vacuum pressure) to laminate the component sheets (i.e., layers) together. In addition, it is perforated and sewn with 4-0 Trisorb suture (polyglycolic acid (PGA); Samyang Corporation, Seoul, South Korea). The suture is distributed in a diamond pattern across the graft and along the periphery and is intended to mitigate delamination of the layers upon rehydration and/or manipulation during implantation. Being a completely biologic device, the Biodesign Hernia Graft is considered MR safe.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hernia recurrence | Hernia recurrence through 1-year follow-up | 1-year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device-, procedure-, and hernia-related adverse event rates | Summarize the adverse event rates for normal commercial use of the device (e.g., seroma and infection rates) | 2-year | 
| Hernia recurrence rate through 2-year follow-up | Assess the long-term success of the device in the reinforcement of hernia repairs through 2-year follow-up | 2-year | 
| Operative times | What was the operation time for the ventral hernia repair? | 2-year | 
| Hospital stay | Duration of hospital stay | 2-year | 
| Hospitalization times for related Serious Adverse Events (SAEs) | What was the hospitalization times for any related SAEs? | 2-year | 
| Patient-reported quality of life: questionaire | Patient-reported quality of life assessed by completion of a questionaire | 2-year |