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A Multicenter, Prospective, Observational Evaluation of Repair of Infected or Contaminated Hernias (RICH) Using LTM


N/A
18 Years
N/A
Not Enrolling
Both
Hernia

Thank you

Trial Information

A Multicenter, Prospective, Observational Evaluation of Repair of Infected or Contaminated Hernias (RICH) Using LTM


Inclusion Criteria:



- is an adult ≥18 years old.

- has need of open abdominal incisional repair of a contaminated or infected site

- has an estimated hernia size of >9cm2 by physical exam

Exclusion Criteria:

- has a nidus of chronic colonization

- has a systemic infection at the time of repair.

- has chronic conditions: hepatic cirrhosis (w/ or w/o ascites); renal failure w/ hemo-
or peritoneal dialysis; incomplete resection of malignant disease; or defined
collagen disorder.

- requires chronic immunosuppressive therapy, including steroids or cytotoxic agents.

- is bedridden or otherwise non-ambulatory.

- is ASA Class 4 or 5.

- has a BMI >40.

- has conditions that would adversely affect subject safety, as per product labeling,
including sensitivities to pork or porcine products.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence of surgical site events

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

Kamal Itani, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Boston VA Healthcare System

Authority:

United States: Institutional Review Board

Study ID:

LFC2007.02.01

NCT ID:

NCT00617357

Start Date:

September 2007

Completion Date:

December 2010

Related Keywords:

  • Hernia
  • incisional hernia
  • abdominal hernia repair
  • Ventral incisional hernia repair
  • Hernia

Name

Location
Baylor College of Medicine Houston, Texas  77030
University of Texas - MD Anderson Cancer Center Houston, Texas  77030-4009
University Hospitals of Cleveland Cleveland, Ohio  44106
Tulane University Medical Center New Orleans, Louisiana  70112
University of Michigan Medical Center Ann Arbor, Michigan  48104-0914
Oregon Health Sciences University Portland, Oregon  
Louisiana State University Health Sciences Center Shreveport, Louisiana  71130
Washington University St. Louis, Missouri  63110
University of North Carolina Hospitals Chapel Hill, North Carolina  27599
University of Maryland Medical Center Baltimore, Maryland  21201-1595
University of Utah Medical Center Salt Lake City, Utah  84132
University of California-San Diego Medical Center La Jolla, California  
Hospital of St Rafael New Haven, Connecticut  
University of Missouri-Columbia Medical Center Columbia, Missouri  
North Shore University Hospital-Long Island Jewish Health System Manhasset, New York  11030