Hernia Repair in Multiply Morbid Patients

Ventral Hernia Clinical Trial

— RAM2P  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00930787
• Other study ID #: LFC2007.03.01
• Status: Terminated
• Phase: Phase 4
• First received: June 29, 2009
• Last updated: September 17, 2013
• Start date: August 2009
• Est. completion date: May 2010

Study information

• Verified date: September 2013
• Source: LifeCell
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hernia
• Hernia, Ventral
• Ventral Hernia

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Maryland	Baltimore	Maryland
United States	University of Maryland Medical Center	Baltimore	Maryland
United States	University Hospital - Case Western	Cleveland	Ohio
United States	Hurley Medical Center	Flint	Michigan
United States	University of Texas - MD Anderson Cancer Center	Houston	Texas
United States	Truman Medical Center	Kansas City	Missouri
United States	Long Island Jewish - North Shore	Lake Success	New York
United States	Louisiana Status University Health Sciences Center	New Orleans	Louisiana
United States	Tulane University	New Orleans	Louisiana
United States	Oregon Health Sciences University	Portland	Oregon
United States	Mayo Clinic	Rochester	Minnesota
United States	Scott & White Medical Center	Temple	Texas
United States	Boston Veterans Administration Healthcare System	West Roxbury	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
LifeCell

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Surgical Site Events (SSEs)		Postoperative Day 30	Yes