Hernia Repair in Multiply Morbid Patients (RAM2P)

September 17, 2013 updated by: LifeCell

A Multicenter, Prospective, Randomized, Controlled, Single-Blinded Study of Strattice Reconstructive Tissue Matrix vs Proceed

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

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

Exclusion Criteria:

  • local or systemic infection
  • expected survival of <24 months
  • non-ambulatory

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of Surgical Site Events (SSEs)
Time Frame: Postoperative Day 30
Postoperative Day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LifeCell

Investigators

  • Principal Investigator: Robert Martindale, MD, Oregon Health and Science University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

June 29, 2009

First Submitted That Met QC Criteria

June 29, 2009

First Posted (Estimate)

June 30, 2009

Study Record Updates

Last Update Posted (Estimate)

November 20, 2013

Last Update Submitted That Met QC Criteria

September 17, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LFC2007.03.01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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