Status:
COMPLETED
Repair of Infected or Contaminated Hernias
Lead Sponsor:
LifeCell
Conditions:
Hernia
Eligibility:
All Genders
18+ years
Phase:
NA
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. Thre...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
83 Patients enrolled
Trial Details
Trial ID
NCT00617357
Start Date
September 1 2007
End Date
December 1 2010
Last Update
December 1 2015
Active Locations (15)
Enter a location and click search to find clinical trials sorted by distance.
1
University of California-San Diego Medical Center
La Jolla, California, United States
2
Hospital of St Rafael
New Haven, Connecticut, United States
3
Louisiana State University Health Sciences Center
New Orleans, Louisiana, United States, 70121
4
Tulane University Medical Center
New Orleans, Louisiana, United States