Repair of Infected or Contaminated Hernias (RICH)

LifeCell

Status

Completed

Conditions

Hernia

Treatments

Device: LTM (Strattice Reconstructive Tissue Matrix)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00617357

LFC2007.02.01

Details and patient eligibility

About

This is a prospective, multicenter, interventional, observational, open label, single arm, longitudinal evaluation of ventral incisional hernia repair using LTM in contaminated or infected sites. Three interim analyses are planned to examine the incidence of surgical site events, postoperative resumption of activities and hernia recurrence.

Enrollment

83 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.