Study Stopped
Stopped early
Hernia Repair in Multiply Morbid Patients
RAM2P
A Multicenter, Prospective, Randomized, Controlled, Single-Blinded Study of Strattice Reconstructive Tissue Matrix vs Proceed
1 other identifier
interventional
23
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Aug 2009
Shorter than P25 for phase_4
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 29, 2009
CompletedFirst Posted
Study publicly available on registry
June 30, 2009
CompletedStudy Start
First participant enrolled
August 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedResults Posted
Study results publicly available
November 20, 2013
CompletedNovember 20, 2013
September 1, 2013
9 months
June 29, 2009
August 16, 2012
September 17, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of Surgical Site Events (SSEs)
Postoperative Day 30
Study Arms (2)
Strattice Reconstructive Tissue Matrix
EXPERIMENTALUse of Strattice Reconstructive Tissue Matrix to support hernia repair
Proceed Surgical Mesh
ACTIVE COMPARATORUse of Proceed Surgical Mesh to support hernia repair
Interventions
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.
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 Criteria
You may qualify if:
- Adults of either gender
- must have 2 or more co-morbidities
You may not qualify if:
- local or systemic infection
- expected survival of \<24 months
- non-ambulatory
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- LifeCelllead
Study Sites (13)
Louisiana Status University Health Sciences Center
New Orleans, Louisiana, 70112, United States
Tulane University
New Orleans, Louisiana, 70115, United States
University of Maryland Medical Center
Baltimore, Maryland, 21201, United States
University of Maryland
Baltimore, Maryland, 21201, United States
Boston Veterans Administration Healthcare System
West Roxbury, Massachusetts, 02132, United States
Hurley Medical Center
Flint, Michigan, 48503, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Truman Medical Center
Kansas City, Missouri, 64108, United States
Long Island Jewish - North Shore
Lake Success, New York, 11042, United States
University Hospital - Case Western
Cleveland, Ohio, 44106, United States
Oregon Health Sciences University
Portland, Oregon, 97239, United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 70115, United States
Scott & White Medical Center
Temple, Texas, 76508, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr Michael Franz
- Organization
- LifeCell
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Martindale, MD
Oregon Health and Science University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 29, 2009
First Posted
June 30, 2009
Study Start
August 1, 2009
Primary Completion
May 1, 2010
Study Completion
May 1, 2010
Last Updated
November 20, 2013
Results First Posted
November 20, 2013
Record last verified: 2013-09