Feasibility of Permacol Use in Infected Fields (NCT00820040) | Clinical Trial Compass
TerminatedPhase 2
Feasibility of Permacol Use in Infected Fields
Stopped: Slow enrollment due to strict eligibility criteria
United States10 participantsStarted 2009-07
Plain-language summary
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
Who can participate
Age range18 Years – 85 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
Number of Participants With Hernia Recurrence or Surgical Site Infection Requiring Wound Opening