Comparative Study of Biologic Mesh Versus Repair With Component Separation.

Not Applicable

Terminated

Interventions: Device: XenMATRIX mesh
Procedure: Open abdominal ventral hernia repair

Brief Summary: 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: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
XenMATRIX	Open abdominal ventral hernia repair	Use of XenMATRIX mesh to repair hernia
XenMATRIX	XenMATRIX mesh	Use of XenMATRIX mesh to repair hernia

Primary Outcome Measures

Name	Time	Method
The Incidence of Postoperative Hernia Recurrence	two years after surgery date

Secondary Outcome Measures

Name	Time	Method
Length of Hospital Stay	Number of days up to 1 week	Participants will be followed for the duration of the hospital stay, an expected average of 1 week
Compare the Short-term Clinical Outcomes of Postoperative Wound Events	two years after surgery date
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