Comparative Study of Biologic Mesh Versus Repair With Component Separation. (Davol)

University Hospitals (UH)

Status: Terminated

Conditions: Ventral Hernia

Treatments: Device: XenMATRIX mesh; Procedure: Open abdominal ventral hernia repair

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01295125

11-10-23

Details and patient eligibility

About

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.

Full 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.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Is an adult ≥ 18 years old of either gender
2. Will undergo a planned open abdominal incisional hernia repair
3. 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)
4. 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
5. 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
6. Has an estimated hernia size of ≥ 3cm to 20cm in maximal width by physical exam
7. Is considered a clean-contaminated or contaminated case per Surgical Site Infection Risk Guidelines
8. Is willing and able to return for all scheduled and required study visits
9. Is willing and able to provide written informed consent for study participation

Exclusion criteria

1. Has a defect that the surgeon cannot achieve primary fascial apposition and requires a bridge of mesh
2. Is a clean or dirty case per Surgical Site Infection Risk Guidelines
3. Has conditions that would adversely affect subject safety as per product labeling
4. Will undergo a laparoscopic hernia repair
5. Has a nidus of chronic colonization, such as chronic indwelling bladder catheter or significant amounts of non-removable infected mesh
6. Has conditions which preclude abdominal imaging at a standard imaging facility
7. Has an anticipated survival of < 24 months
8. Care plan is to perform a staged repair over 45 days
9. Is bedridden or otherwise non-ambulatory (i.e. is unable to independently transfer into and out of a wheelchair)
10. Is ASA class 4 or 5
11. BMI over 45
12. Is pregnant

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

XenMATRIX

Experimental group

Description:

Use of XenMATRIX mesh to repair hernia

Treatment:

Procedure: Open abdominal ventral hernia repair

Device: XenMATRIX mesh