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

18 Years
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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:


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:


Principal Investigator

Kamal Itani, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Boston VA Healthcare System


United States: Institutional Review Board

Study ID:




Start Date:

September 2007

Completion Date:

December 2010

Related Keywords:

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



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