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


Phase 4
18 Years
N/A
Not Enrolling
Both
Ventral Hernia

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Incidence of postoperative wound events

Outcome Time Frame:

Postoperative Day 30

Safety Issue:

Yes

Principal Investigator

Robert Martindale, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Oregon Health and Science University

Authority:

United States: Institutional Review Board

Study ID:

LFC2007.03.01

NCT ID:

NCT00930787

Start Date:

August 2009

Completion Date:

May 2012

Related Keywords:

  • Ventral Hernia
  • hernia repair, surgical mesh, co-morbidities
  • Hernia
  • Hernia, Ventral

Name

Location
Mayo Clinic Rochester, Minnesota  55905
University of Texas - MD Anderson Cancer Center Houston, Texas  77030-4009
Hurley Medical Center Flint, Michigan  48503
Oregon Health Sciences University Portland, Oregon  
University of Maryland Baltimore, Maryland  21201
University of Maryland Medical Center Baltimore, Maryland  21201-1595
Truman Medical Center Kansas City, Missouri  64108
Tulane University New Orleans, Louisiana  70112-2699
Louisiana Status University Health Sciences Center New Orleans, Louisiana  70112
Boston Veterans Administration Healthcare System West Roxbury, Massachusetts  02132
Long Island Jewish - North Shore Lake Success, New York  11042
University Hospital - Case Western Cleveland, Ohio  44106
Scott & White Medical Center Temple, Texas  76508