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Feasibility of Permacol Use in Infected Fields

Primary Purpose

Hernia

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
acellular porcine dermal collagen mesh
Sponsored by
Medtronic - MITG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hernia focused on measuring Hernia, Contaminated Field, Mesh Removal, infected mesh removal

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Kentucky
  • Albany Medical College
  • Greenville Hospital System

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Permacol

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
January 7, 2009
Last Updated
November 15, 2020
Sponsor
Medtronic - MITG
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1. Study Identification

Unique Protocol Identification Number
NCT00820040
Brief Title
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

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Terminated
Why Stopped
Slow enrollment due to strict eligibility criteria
Study Start Date
July 2009 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic - MITG

4. Oversight

Data Monitoring Committee
No

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hernia
Keywords
Hernia, Contaminated Field, Mesh Removal, infected mesh removal

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Permacol
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
acellular porcine dermal collagen mesh
Other Intervention Name(s)
Permacol
Intervention Description
porcine mesh for hernia repair/ abdominal wall reconstruction
Primary Outcome Measure Information:
Title
Number of Participants With Hernia Recurrence or Surgical Site Infection Requiring Wound Opening
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Subjects Having Permacol Implants Removed or Debrided After Implantation
Description
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.
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Physical and Other Examinations
Description
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.
Time Frame
12-month post-procedure change from baseline
Title
Physical and Other Examinations
Description
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.
Time Frame
Baseline
Title
Physical and Other Examinations
Description
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.
Time Frame
12-month post-procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Roth, MD
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Albany Medical College
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Greenville Hospital System
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States

12. IPD Sharing Statement

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Feasibility of Permacol Use in Infected Fields

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