Repair of Infected or Contaminated Hernias
- Conditions
- Hernia
- Interventions
- Device: LTM (Strattice Reconstructive Tissue Matrix)
- Registration Number
- NCT00617357
- Lead Sponsor
- LifeCell
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 83
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 LTM (Strattice Reconstructive Tissue Matrix) Strattice Reconstructive Tissue Matrix
- Primary Outcome Measures
Name Time Method Incidence of Wound Events Postoperatively up to 24 months Wound Events are defined as those events which occurred in the area of the hernia repair and the repair site, including seroma, hematoma, dehiscence, infection, abscess, fistula, and re-herniation.
- Secondary Outcome Measures
Name Time Method Activities Assessment Scale (AAS) 24 Months The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from "No difficulty" to "Not able to do it." The AAS has three subscales: sedentary activities (items 1-4); ambulatory activities (items 6-8); work/exercise activities (items 11-13). The AAS total and subscale scores are transformed to produce a range of 0-100, with higher values indicating greater functional activity.
Trial Locations
- Locations (15)
University of Missouri-Columbia Medical Center
🇺🇸Columbia, Missouri, United States
University of California-San Diego Medical Center
🇺🇸La Jolla, California, United States
Tulane University Medical Center
🇺🇸New Orleans, Louisiana, United States
University of Michigan Medical Center
🇺🇸Ann Arbor, Michigan, United States
University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States
Louisiana State University Health Sciences Center
🇺🇸New Orleans, Louisiana, United States
Washington University
🇺🇸St Louis, Missouri, United States
North Shore University Hospital-Long Island Jewish Health System
🇺🇸Manhasset, New York, United States
University of North Carolina Hospitals
🇺🇸Chapel Hill, North Carolina, United States
Oregon Health Sciences University
🇺🇸Portland, Oregon, United States
University of Texas - MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
University of Utah Medical Center
🇺🇸Salt Lake City, Utah, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Hospital of St Rafael
🇺🇸New Haven, Connecticut, United States
University Hospitals of Cleveland
🇺🇸Cleveland, Ohio, United States