Feasibility of Permacol Use in Infected Fields

Study Overview
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Brief Summary
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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

Official Title
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To Examine the Feasibility of Using Permacol® Surgical Implant in the Repair of Abdominal Wall Defects After Removal of Chronic Infect Prosthetic Mesh

Conditions
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Hernia

Intervention / Treatment
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* Device: acellular porcine dermal collagen mesh


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Permacol<br> | Device: acellular porcine dermal collagen mesh<br>* porcine mesh for hernia repair/ abdominal wall reconstruction<br>* Other names: Permacol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Hernia Recurrence or Surgical Site Infection Requiring Wound Opening | The primary objective of this study was hernia recurrence or surgical site infection as assessed by a CT scan 12 months following surgery.Hernia recurrence was defined as any abnormal abdominal protrusion, as assessed by 12 month CT. Surgical site infection requiring wound opening was defined as abscess formation or drainage that required surgical wound opening. Wound opening was defined as surgical entry into the wound. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjects Having Permacol Implants Removed or Debrided After Implantation | The secondary objective of this study was the incidence of Permacol™ surgical implant removal or debridement. Removal was defined as complete surgical excision of the implant. Debridement was defined as debridement or lavage of ≥10% of the visible implant surface area as subjectively assessed by the operating surgeon. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hernia, Contaminated Field, Mesh Removal, infected mesh removal