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

This study has been completed.
Sponsor:
Collaborator:
C. R. Bard
Information provided by (Responsible Party):
Michael J. Rosen, MD., University Hospitals of Cleveland
ClinicalTrials.gov Identifier:
NCT01295125
First received: February 11, 2011
Last updated: June 25, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Ventral Hernia
Device: XenMATRIX mesh
Procedure: Open abdominal ventral hernia repair
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Randomized Control Trial of Biologic Mesh (XenMATRIXTM) vs. Component Separation Alone in Contaminated Ventral Hernia Repair:a Pilot Study

Resource links provided by NLM:


Further study details as provided by University Hospitals of Cleveland:

Primary Outcome Measures:
  • The incidence of postoperative hernia recurrence [ Time Frame: two years after surgery date ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Compare the short-term clinical outcomes of postoperative wound events [ Time Frame: two years after surgery date ] [ Designated as safety issue: No ]
  • Length of hospital stay [ Time Frame: Number of days up to 1 week ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Antibiotic usage and days [ Time Frame: two years after surgery date ] [ Designated as safety issue: No ]
  • Resumption of Activities of Daily Living [ Time Frame: two years after surgery date ] [ Designated as safety issue: No ]

Enrollment: 9
Study Start Date: January 2011
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Davol Biologic mesh
Active Comparator: Native tissue
Repair with participants native tissue
Procedure: Open abdominal ventral hernia repair
Abdominal ventral hernia repair with native tissue
Other Name: Abdominal ventral hernia repair with native tissue

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01295125

Locations
United States, Ohio
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
Michael J. Rosen, MD.
C. R. Bard
Investigators
Principal Investigator: Michael J. Rosen, MD. University Hospitals of Cleveland Case Medical Center
  More Information

No publications provided

Responsible Party: Michael J. Rosen, MD., Principal Investigator, University Hospitals of Cleveland
ClinicalTrials.gov Identifier: NCT01295125     History of Changes
Other Study ID Numbers: 11-10-23
Study First Received: February 11, 2011
Last Updated: June 25, 2012
Health Authority: United States: Institutional Review Board
United States: Federal Government
United States: Food and Drug Administration

Keywords provided by University Hospitals of Cleveland:
Infected ventral hernia
Contaminated incisional hernia

Additional relevant MeSH terms:
Hernia
Hernia, Ventral
Pathological Conditions, Anatomical
Hernia, Abdominal

ClinicalTrials.gov processed this record on April 17, 2014