Comparative Study of Biologic Mesh Versus Repair With Component Separation.

Study Overview
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Brief Summary
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The purpose of this study is to compare open abdominal incisional hernia repair using XenMATRIX biologic mesh versus repair with their own tissue. This study will provide information in determining if a biological mesh is necessary to provide a sturdy repair for a ventral hernia.

Detailed Description
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This study will involve comparison of open abdominal incisional hernia repair with XenMATRIX biologic graft versus repair with native tissue. The current study seeks to evaluate XenMATRIXTM, an FDA approved biologic graft for repairing contaminated abdominal wall defects. This study will provide significant insight for the reconstructive surgeon and patient to determine whether a biologic graft is necessary for the reconstruction of a contaminated ventral hernia repair to provide a durable single staged repair.

Official Title
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Randomized Control Trial of Biologic Mesh (XenMATRIXTM) vs. Component Separation Alone in Contaminated Ventral Hernia Repair:a Pilot Study

Conditions
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Ventral Hernia

Intervention / Treatment
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* Device: XenMATRIX mesh
* Procedure: Open abdominal ventral hernia repair


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Is an adult ≥ 18 years old of either gender Will undergo a planned open abdominal incisional hernia repair Has a defect that can be repaired primarily without tension with myofascial advancement flaps and requires no more than 1 piece of surgical mesh (largest mesh size (19 x 35 cm) Contamination is known preoperatively, e.g. repair in the presence of a chronic wound, the presence of a stoma or in conjunction with a bowel resection, or such contaminations occurs intraoperatively, e.g. inadvertent enterotomy or opening of other hollow intra-abdominal viscus Infection is known due to local frank signs of incisional drainage, fistula formation or abdominal abscess following prior surgical abdominal surgery or presence of infected mesh Has an estimated hernia size of ≥ 3cm to 20cm in maximal width by physical exam Is considered a clean-contaminated or contaminated case per Surgical Site Infection Risk Guidelines Is willing and able to return for all scheduled and required study visits Is willing and able to provide written informed consent for study participation Exclusion Criteria: Has a defect that the surgeon cannot achieve primary fascial apposition and requires a bridge of mesh Is a clean or dirty case per Surgical Site Infection Risk Guidelines Has conditions that would adversely affect subject safety as per product labeling Will undergo a laparoscopic hernia repair Has a nidus of chronic colonization, such as chronic indwelling bladder catheter or significant amounts of non-removable infected mesh Has conditions which preclude abdominal imaging at a standard imaging facility Has an anticipated survival of < 24 months Care plan is to perform a staged repair over 45 days Is bedridden or otherwise non-ambulatory (i.e. is unable to independently transfer into and out of a wheelchair) Is ASA class 4 or 5 BMI over 45 Is pregnant

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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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: XenMATRIX<br>Use of XenMATRIX mesh to repair hernia | Device: XenMATRIX mesh<br>* Use of XenMATRIX mesh in the repair of contaminated ventral hernia repair<br>* Other names: Davol Biologic mesh;Procedure: Open abdominal ventral hernia repair<br>* Abdominal ventral hernia repair with native tissue<br>* Other names: Abdominal ventral hernia repair with native tissue;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Incidence of Postoperative Hernia Recurrence |  | two years after surgery date | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the Short-term Clinical Outcomes of Postoperative Wound Events |  | two years after surgery date | 
| Length of Hospital Stay | Participants will be followed for the duration of the hospital stay, an expected average of 1 week | Number of days up to 1 week | 
| Length of Resource Utilization |  | two years after surgery date | 
| Antibiotic Usage and Days |  | two years after surgery date | 
| Resumption of Activities of Daily Living |  | two years after surgery date | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infected ventral hernia, Contaminated incisional hernia