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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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83 participants in 1 patient group

1

Experimental group

Description:

Strattice Reconstructive Tissue Matrix

Treatment:

Device: LTM (Strattice Reconstructive Tissue Matrix)