Feasibility of Permacol Use in Infected Fields

Medtronic

Status and phase

Terminated

Phase 2

Conditions

Hernia

Treatments

Device: acellular porcine dermal collagen mesh

Study type

Interventional

Funder types

Industry

Identifiers

NCT00820040

Hern06R2

Details and patient eligibility

About

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

Enrollment

10 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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