Hernia Repair in Multiply Morbid Patients (RAM2P)

This study has been terminated.
(Stopped early)
Sponsor:
Information provided by (Responsible Party):
LifeCell
ClinicalTrials.gov Identifier:
NCT00930787
First received: June 29, 2009
Last updated: September 17, 2013
Last verified: September 2013
  Purpose

Support of a ventral hernia repair with a prosthetic mesh has been demonstrated to result in a diminished rate of hernia recurrence. The patient with co-morbidities undergoing hernia repair is at increased risk of wound related complications, which may be exacerbated by the choice of prosthetic mesh, and which are known to influence the ultimate rate of hernia recurrence. It is hypothesized that patients receiving a mesh of biologic origin may experience fewer wound related complications and hence at least an equal rate of hernia recurrence, compared to those receiving a synthetic mesh.


Condition Intervention Phase
Ventral Hernia
Device: Strattice Reconstructive Tissue Matrix (Hernia Repair)
Device: Proceed Surgical Mesh (Hernia repair)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Prospective, Randomized, Controlled, Single-Blinded Study of Strattice Reconstructive Tissue Matrix vs Proceed

Resource links provided by NLM:


Further study details as provided by LifeCell:

Primary Outcome Measures:
  • Incidence of Surgical Site Events (SSEs) [ Time Frame: Postoperative Day 30 ] [ Designated as safety issue: Yes ]

Enrollment: 23
Study Start Date: August 2009
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Strattice Reconstructive Tissue Matrix
Use of Strattice Reconstructive Tissue Matrix to support hernia repair
Device: Strattice Reconstructive Tissue Matrix (Hernia Repair)
Hernia repair will be performed, in an open fashion and defect will be closed or reduced in size using musculofascial centralization procedures to reestablish midline.
Active Comparator: Proceed Surgical Mesh
Use of Proceed Surgical Mesh to support hernia repair
Device: Proceed Surgical Mesh (Hernia repair)
Hernia repair will be performed, in an open fashion and defect will be closed or reduced in size using musculofascial centralization procedures to reestablish midline.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults of either gender
  • must have 2 or more co-morbidities

Exclusion Criteria:

  • local or systemic infection
  • expected survival of <24 months
  • non-ambulatory
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00930787

Locations
United States, Louisiana
Tulane University
New Orleans, Louisiana, United States, 70115
Louisiana Status University Health Sciences Center
New Orleans, Louisiana, United States, 70112
United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Boston Veterans Administration Healthcare System
West Roxbury, Massachusetts, United States, 02132
United States, Michigan
Hurley Medical Center
Flint, Michigan, United States, 48503
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Missouri
Truman Medical Center
Kansas City, Missouri, United States, 64108
United States, New York
Long Island Jewish - North Shore
Lake Success, New York, United States, 11042
United States, Ohio
University Hospital - Case Western
Cleveland, Ohio, United States, 44106
United States, Oregon
Oregon Health Sciences University
Portland, Oregon, United States, 97239
United States, Texas
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 70115
Scott & White Medical Center
Temple, Texas, United States, 76508
Sponsors and Collaborators
LifeCell
Investigators
Principal Investigator: Robert Martindale, MD Oregon Health and Science University
  More Information

No publications provided

Responsible Party: LifeCell
ClinicalTrials.gov Identifier: NCT00930787     History of Changes
Other Study ID Numbers: LFC2007.03.01
Study First Received: June 29, 2009
Results First Received: August 16, 2012
Last Updated: September 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by LifeCell:
hernia repair, surgical mesh, co-morbidities

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

ClinicalTrials.gov processed this record on September 30, 2014