Safety Study of MotifMESH (cPTFE) in Abdominal Surgery

Completed · Not applicable

Conditions studied: Hernia

In brief

This study will monitor surgically repaired large abdominal hernias requiring condensed fenestrated polytetrafluoroethylene mesh (cPTFE).

Key facts

Study ID

NCT01364233

Run by

Medline Industries

People needed

10

Starts

2011-05-01

Expected to finish

2014-03-01

Last updated by the study team

2019-02-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Has a non-sterile abdominal wall defect (incisional hernia or fascial defect) and needs to be repaired

You may not qualify 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

Where it is running

• Division of Plastic Surgery — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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