Comparative Study of Biologic Mesh Versus Repair With Component Separation.

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2012

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.

Interventions

  • Device: XenMATRIX mesh
    • Use of XenMATRIX mesh in the repair of contaminated ventral hernia repair
  • Procedure: Open abdominal ventral hernia repair
    • Abdominal ventral hernia repair with native tissue

Arms, Groups and Cohorts

  • Experimental: XenMATRIX
    • Use of XenMATRIX mesh to repair hernia

Clinical Trial Outcome Measures

Primary Measures

  • The Incidence of Postoperative Hernia Recurrence
    • Time Frame: two years after surgery date

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University Hospitals Cleveland Medical Center
  • Collaborator
    • Bard Ltd
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Michael J. Rosen, MD., Principal Investigator, University Hospitals Cleveland Medical Center

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