Feasibility of Permacol Use in Infected Fields

• ClinicalTrials.gov Identifier: NCT00820040
• Recruitment Status: Terminated
• First Posted: January 9, 2009
• Results First Posted: December 9, 2020
• Last Update Posted: December 9, 2020
• Sponsor: Medtronic - MITG
• Information provided by (Responsible Party): Medtronic - MITG

Study Description

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

Condition or disease	Intervention/treatment	Phase
Hernia	Device: acellular porcine dermal collagen mesh	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: July 2009
• Actual Primary Completion Date: August 2011
• Actual Study Completion Date: August 2011

Arms and Interventions

Arm	Intervention/treatment
Experimental: Permacol	Device: acellular porcine dermal collagen mesh; porcine mesh for hernia repair/ abdominal wall reconstruction; Other Name: Permacol

Outcome Measures

Primary Outcome Measures :

1. Number of Participants With Hernia Recurrence or Surgical Site Infection Requiring Wound Opening [ Time Frame: 12 months ]
   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.

Secondary Outcome Measures :

1. Subjects Having Permacol Implants Removed or Debrided After Implantation [ Time Frame: 12 months ]
   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.

Other Outcome Measures:

1. Physical and Other Examinations [ Time Frame: 12-month post-procedure change from baseline ]
   The SF-12v2 Health Survey® (12-question short form health survey) measure eight domains of health related quality of life, which is then aggregated to provide summary measure of the respondent's physical and mental health. Results of 12-month abdominal CT examination are summarized as a change from the baseline. The SF-12v2 Health Survey® is broken into physical health and mental health. Physical health is determined by: physical functioning, role-playing, bodily pain and general health. Mental health is determined by: vitality, social functioning, role-emotional and mental health. The general population mean of the United States is 50. When analyzing the results, the mean values of the study subjects are taken and compared to the general United States population. Each 10 points represent one standard deviation. A measure of one standard deviation (10 points) below the population mean (50) indicates significant function impairment.
2. Physical and Other Examinations [ Time Frame: Baseline ]
   The SF-12v2 Health Survey® (12-question short form health survey) measure eight domains of health related quality of life, which is then aggregated to provide summary measure of the respondent's physical and mental health. Results of 12-month abdominal CT examination are summarized as a change from the baseline. The SF-12v2 Health Survey® is broken into physical health and mental health. Physical health is determined by: physical functioning, role-playing, bodily pain and general health. Mental health is determined by: vitality, social functioning, role-emotional and mental health. The general population mean of the United States is 50. When analyzing the results, the mean values of the study subjects are taken and compared to the general United States population. Each 10 points represent one standard deviation. A measure of one standard deviation (10 points) below the population mean (50) indicates significant function impairment.
3. Physical and Other Examinations [ Time Frame: 12-month post-procedure ]
   The SF-12v2 Health Survey® (12-question short form health survey) measure eight domains of health related quality of life, which is then aggregated to provide summary measure of the respondent's physical and mental health. Results of 12-month abdominal CT examination are summarized as a change from the baseline. The SF-12v2 Health Survey® is broken into physical health and mental health. Physical health is determined by: physical functioning, role-playing, bodily pain and general health. Mental health is determined by: vitality, social functioning, role-emotional and mental health. The general population mean of the United States is 50. When analyzing the results, the mean values of the study subjects are taken and compared to the general United States population. Each 10 points represent one standard deviation. A measure of one standard deviation (10 points) below the population mean (50) indicates significant function impairment.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Kentucky

University of Kentucky

Lexington, Kentucky, United States, 40536

United States, New York

Albany Medical College

Albany, New York, United States, 12208

United States, South Carolina

Greenville Hospital System

Greenville, South Carolina, United States, 29605

Sponsors and Collaborators

Medtronic - MITG

Investigators

• Principal Investigator: John Roth, MD; University of Kentucky

More Information

• Responsible Party: Medtronic - MITG
• ClinicalTrials.gov Identifier: NCT00820040
• Other Study ID Numbers: Hern06R2
• First Posted: January 9, 2009
• Results First Posted: December 9, 2020
• Last Update Posted: December 9, 2020
• Last Verified: November 2020

Keywords provided by Medtronic - MITG:

Hernia; Contaminated Field; Mesh Removal; infected mesh removal

Additional relevant MeSH terms:

Hernia; Pathological Conditions, Anatomical