Gentrix® Surgical Matrix for Soft Tissue Reinforcement in Ventral Hernia Repair

Study Overview
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Brief Summary
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The purpose of this study is to collect additional safety data and demonstrate the performance of Integra Gentrix® Surgical Matrix for reinforcement of ventral hernia repairs.

Detailed Description
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Retrospective data will be collected and assessed for early post-operative surgical site events and complications in the immediate post-operative period of 90 days.

Official Title
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A Retrospective Analysis of the Use of Gentrix® Surgical Matrix for Soft Tissue Reinforcement in Ventral Hernia Repair

Conditions
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Ventral Hernia

Intervention / Treatment
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* Device: Retrospective chart review


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients between 22 years and 80 years old (inclusive) at time they underwent abdominal wall reconstruction utilizing Gentrix® Surgical Matrix as a reinforcement graft during the time period between November 1, 2017, and present (90 days prior to the start of the data collection).. Subject underwent abdominal wall reconstruction for a hernia(s) using Integra® Gentrix® Surgical Matrix. Exclusion Criteria: Subject has known allergy to porcine-derived products. Subject required use of Gentrix® device and a second non-Gentrix surgical mesh in the same plane or in different planes for single hernia e.g., Gentrix sublay and a synthetic device in the onlay position. Subject had active necrotizing fasciitis or any current known uncontrolled systemic infection. Subject had uncontrolled diabetes, defined as Hb1AC value >7% within 12 weeks prior to index procedure. Subject has been diagnosed with cirrhosis and/or ascites.

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 80 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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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Retrospective chart review|The retrospective chart review will include the full consecutive series of patients between 22 years and 80 years old who underwent abdominal wall reconstruction for achart hernia with Integra Gentrix® Surgical Matrix during the time period between November 1, 2017, and present (90 days prior to the start of data collection).|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of post-operative complications requiring procedural intervention within 90 days post index procedure | Percentage of subjects with a post-operative complications requiring procedural intervention within 90 days post index procedure | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of early post-operative complications (Surgical Site Occurrences (SSOs)) within 90 days post index procedure | Percentage of subjects with an early post-operative complications (Surgical Site Occurrences (SSOs)) within 90 days post index procedure | 90 days | 
| Incidence of Surgical Site Infections (SSIs) Post index procedure | Percentage of subjects with SSIs Post index procedure | 90 days | 
| Incidence of later post-operative complications after 90 days post index procedure | Percentage of subjects with a later post-operative complications after 90 days post index procedure | 1 year | 
| Incidence of hernia recurrence confirmed by clinical assessment | Percentage of subjects with a hernia recurrence confirmed by clinical assessment | 1 year | 
| Incidence of reoperation requirement due to index repair | Percentage of subjects with a reoperation requirement due to index repair | 1 year |