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 @ 4:47 PM
Ignite Modification Date:
2025-12-24 @ 4:47 PM
NCT ID:
NCT01594450
Eligibility Criteria:
Inclusion Criteria:
* wound infection related to a synthetic non-absorbable mesh for at least 15 days duration
* incisional abdominal hernia with an abcess or fistula, without the presence of a synthetic non-absorbable mesh
* incisional abdominal hernias smaller than 20 centimeter in the 2 largest diameters
* incisional abdominal hernias requiring a surgical procedure
* incisional abdominal hernias amenable to repair with a single biological mesh
* age over 18 years
Exclusion Criteria:
* non-infected incisional abdominal hernia
* history of biological mesh placement
* incisional abdominal hernia in contaminated, but non infected field (stoma presence, violation of gastrointestinal tract)
* incisional abdominal hernia larger than 20 x 20 cm
* BMI ≥ 40 kg/m2
* ASA score 4 and 5
* immunosuppression (including steroid and cytotoxic therapy)
* chronic disease such as cirrhosis, renal insufficiency with renal dialysis, malignant disease, known collagen disorder
* life expectancy under than 36 months
* allergy to one of the biological mesh components
* pregnancy or breastfeeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01594450
Study Brief:
Protocol Section:
NCT01594450