Feasibility of Permacol Use in Infected Fields

NCT ID: NCT00820040

Last Updated: 2020-12-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2011-08-31

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

Conditions

Hernia

Keywords

Hernia; Contaminated Field; Mesh Removal; infected mesh removal

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Permacol

Group Type: EXPERIMENTAL

acellular porcine dermal collagen mesh

Intervention Type: DEVICE

porcine mesh for hernia repair/ abdominal wall reconstruction

Interventions

acellular porcine dermal collagen mesh

porcine mesh for hernia repair/ abdominal wall reconstruction

Intervention Type: DEVICE

Other Intervention Names

Permacol

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic - MITG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Roth, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

University of Kentucky

Lexington, Kentucky, United States

Albany Medical College

Albany, New York, United States

Greenville Hospital System

Greenville, South Carolina, United States

Countries

United States

Other Identifiers

Hern06R2

Identifier Type: -

Identifier Source: org_study_id