Comparative Study of Biologic Mesh Versus Repair With Component Separation.

NCT ID: NCT01295125

Last Updated: 2023-01-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2012-05-31

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.

Conditions

Ventral Hernia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

XenMATRIX

Use of XenMATRIX mesh to repair hernia

Group Type: EXPERIMENTAL

XenMATRIX mesh

Intervention Type: DEVICE

Use of XenMATRIX mesh in the repair of contaminated ventral hernia repair

Open abdominal ventral hernia repair

Intervention Type: PROCEDURE

Abdominal ventral hernia repair with native tissue

Interventions

XenMATRIX mesh

Use of XenMATRIX mesh in the repair of contaminated ventral hernia repair

Intervention Type: DEVICE

Open abdominal ventral hernia repair

Abdominal ventral hernia repair with native tissue

Intervention Type: PROCEDURE

Other Intervention Names

Davol Biologic mesh; Abdominal ventral hernia repair with native tissue

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bard Ltd

INDUSTRY

Sponsor Role: collaborator

University Hospitals Cleveland Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael J. Rosen, MD.

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland Medical Center

Locations

University Hospitals Case Medical Center

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

11-10-23

Identifier Type: -

Identifier Source: org_study_id