Clinical trial NCT00820040: Feasibility of Permacol Use in Infected Fields
Official title: To Examine the Feasibility of Using Permacol® Surgical Implant in the Repair of Abdominal Wall Defects After Removal of Chronic Infect Prosthetic Mesh
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Hernia
Keywords: Hernia
Contaminated Field
Mesh Removal
infected mesh removal
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2009-01-09
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Hernia Recurrence or Surgical Site Infection Requiring Wound Opening
timeFrame: 12 months
Secondary outcomes:
measure: Subjects Having Permacol Implants Removed or Debrided After Implantation
timeFrame: 12 months
Other outcomes:
measure: Physical and Other Examinations
timeFrame: 12-month post-procedure change from baseline
measure: Physical and Other Examinations
timeFrame: Baseline
measure: Physical and Other Examinations
timeFrame: 12-month post-procedure
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Albany
country: United States
facility: Albany Medical College
state: New York
city: Greenville
country: United States
facility: Greenville Hospital System
state: South Carolina
Study officials:
affiliation: University of Kentucky
name: John Roth, MD
role: PRINCIPAL_INVESTIGATOR
References: