Feasibility of Permacol Use in Infected Fields

Stopped early · Phase 2

Conditions studied: Hernia

In brief

This pilot study is to examine the feasibility of using Permacol Surgical Implant in the repair of abdominal wall defects after removal of infected prosthetic mesh

Key facts

Study ID

NCT00820040

Run by

Medtronic - MITG

People needed

10

Starts

2009-07-01

Expected to finish

2011-08-01

Last updated by the study team

2020-12-09

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Have given written Informed Consent
• Be 18-85 years of age (inclusive)
• Have prosthetic mesh that is in proximity to an infected wound that has failed conservative management for at least 3 months, with mesh exposure and a draining wound, or that is in proximity to an abscess that requires operative intervention.
• Have a wound characterized by purulent discharge, positive gram stain or positive culture to document infection
• Be a candidate for surgical removal of infected mesh placed for repair of ventral/incisional hernias and concomitant abdominal wall reconstruction
• Have an ASA Score ≤3
• Have a body mass index (BMI) between 16.5 and 40 inclusive
• Be a candidate for anticipated primary approximation of skin/wound
• Have a life expectancy of at least 18 months
• Be willing to allow biopsy of implant if secondary wound opening is performed or spontaneous implant exposure occurs

You may not qualify if…

• Have loss of abdominal domain such that the operation would be impractical or would adversely effect respiratory or cardiovascular function to an unacceptable degree
• Have an enterocutaneous fistula in proximity to wound/mesh
• Be a candidate for emergency surgery that would make giving valid Informed Consent impractical
• Be currently taking part in another clinical study that conflicts with the current study
• Have known allergy to porcine collagen products
• Have active generalized peritonitis or intraperitoneal sepsis
• Have active necrotizing fasciitis
• Have active abdominal compartment syndrome
• Have active untreated metabolic or systemic illness
• Report unintentional weight loss >10% of body weight in the previous 90 days
• Have known collagen metabolism disorder.(e.g., Ehlers-Danlos syndrome)
• Have known altered immune response (e.g., HIV or other immunodeficiency disorder))
• Have chronic renal failure
• Have known active malignancy present
• Have history of systemic chemotherapy within previous 1 year
• Have lifetime history of radiation to the abdomen, pelvis or thorax
• Have inguinal or groin hernia as primary diagnosis
• Be currently pregnant or planning to become pregnant during study period
• Be unable to give valid informed consent or comply with required follow- up schedule
• Suffer from mental capacity sufficiently severe to make informed consent unobtainable

Where it is running

• University of Kentucky — Lexington, Kentucky, United States
• Albany Medical College — Albany, New York, United States
• Greenville Hospital System — Greenville, South Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.