Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2025-12-24 @ 6:35 PM
NCT ID:
NCT00617357
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00617357
Study Brief:
Protocol Section:
NCT00617357