Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Medline Industries
cPTFEi s a mesh-like product designed to reduce associated post surgical complications.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Has a non-sterile abdominal wall defect (incisional hernia or fascial defect) and needs to be repaired
You may not be if
Non-pregnant, breast feeding or plans to become pregnant during the study; Using adequate birth control methods and agrees to continue using those methods for the duration of the study
Confirmation of incisional hernia or fascial defect by CT scan within 6 months Incisional hernia or facial defect has no necrotic tissue. Such as fascial dehiscence, evisceration, small or large bowel repair, stoma manipulation, small chronic abdominal skin wounds, bowel obstruction
Acceptable state of health and nutrition with pre-albumin levels of ≥ 15 mg/dL (0.15 g/L), serum albumin ≥ 2.0 g/dL (20 g/L). No abnormal pre-surgery laboratory values that, in the opinion of the Principal Investigator, place the subject at risk for the study.
For subjects with Diabetes Mellitus, HbA1C \<12%
BMI ≤ 40 kg/m²
Clareo Health | Safety Study of MotifMESH (cPTFE) in Abdominal Surgery
