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Hernia Repair in Multiply Morbid Patients (RAM2P)

Primary Purpose

Ventral Hernia

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Strattice Reconstructive Tissue Matrix (Hernia Repair)
Proceed Surgical Mesh (Hernia repair)
Sponsored by
LifeCell
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ventral Hernia focused on measuring hernia repair, surgical mesh, co-morbidities

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Louisiana Status University Health Sciences Center
  • Tulane University
  • University of Maryland Medical Center
  • University of Maryland
  • Boston Veterans Administration Healthcare System
  • Hurley Medical Center
  • Mayo Clinic
  • Truman Medical Center
  • Long Island Jewish - North Shore
  • University Hospital - Case Western
  • Oregon Health Sciences University
  • University of Texas - MD Anderson Cancer Center
  • Scott & White Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Strattice Reconstructive Tissue Matrix

Proceed Surgical Mesh

Arm Description

Use of Strattice Reconstructive Tissue Matrix to support hernia repair

Use of Proceed Surgical Mesh to support hernia repair

Outcomes

Primary Outcome Measures

Incidence of Surgical Site Events (SSEs)

Secondary Outcome Measures

Full Information

First Posted
June 29, 2009
Last Updated
September 17, 2013
Sponsor
LifeCell
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1. Study Identification

Unique Protocol Identification Number
NCT00930787
Brief Title
Hernia Repair in Multiply Morbid Patients
Acronym
RAM2P
Official Title
A Multicenter, Prospective, Randomized, Controlled, Single-Blinded Study of Strattice Reconstructive Tissue Matrix vs Proceed
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Terminated
Why Stopped
Stopped early
Study Start Date
August 2009 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LifeCell

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventral Hernia
Keywords
hernia repair, surgical mesh, co-morbidities

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Strattice Reconstructive Tissue Matrix
Arm Type
Experimental
Arm Description
Use of Strattice Reconstructive Tissue Matrix to support hernia repair
Arm Title
Proceed Surgical Mesh
Arm Type
Active Comparator
Arm Description
Use of Proceed Surgical Mesh to support hernia repair
Intervention Type
Device
Intervention Name(s)
Strattice Reconstructive Tissue Matrix (Hernia Repair)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Proceed Surgical Mesh (Hernia repair)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of Surgical Site Events (SSEs)
Time Frame
Postoperative Day 30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Martindale, MD
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Louisiana Status University Health Sciences Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Tulane University
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Boston Veterans Administration Healthcare System
City
West Roxbury
State/Province
Massachusetts
ZIP/Postal Code
02132
Country
United States
Facility Name
Hurley Medical Center
City
Flint
State/Province
Michigan
ZIP/Postal Code
48503
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Truman Medical Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Long Island Jewish - North Shore
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
University Hospital - Case Western
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Oregon Health Sciences University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
University of Texas - MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
70115
Country
United States
Facility Name
Scott & White Medical Center
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States

12. IPD Sharing Statement

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Hernia Repair in Multiply Morbid Patients

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