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

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

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.

Study Overview

• Status: Terminated
• Conditions: Ventral Hernia
• Intervention / Treatment: Device: XenMATRIX mesh; Procedure: Open abdominal ventral hernia repair

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.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Case Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: XenMATRIX; Use of XenMATRIX mesh to repair hernia	Device: XenMATRIX mesh; Use of XenMATRIX mesh in the repair of contaminated ventral hernia repair; Other Names: Davol Biologic mesh; Procedure: Open abdominal ventral hernia repair; Abdominal ventral hernia repair with native tissue; Other Names: Abdominal ventral hernia repair with native tissue

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University Hospitals Cleveland Medical Center
• Collaborators: Bard Ltd
• Investigators: Principal Investigator: Michael J. Rosen, MD., University Hospitals Cleveland Medical Center

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: February 11, 2011
• First Submitted That Met QC Criteria: February 11, 2011
• First Posted (Estimate): February 14, 2011

Study Record Updates

• Last Update Posted (Estimate): January 24, 2023
• Last Update Submitted That Met QC Criteria: January 3, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Infected ventral hernia; Contaminated incisional hernia
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Ventral
• Other Study ID Numbers: 11-10-23