Feasibility of Permacol Use in Infected Fields

• Sponsor: Medtronic - MITG (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00820040
• Collaborator: (none)
• Enrollment: 10
• Locations: 3
• Arm: 1
• Duration (Months): 25
• Patients Per Site: 3.3
• Patients Per Site Per Month: 0.1

Study Details

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
• 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: Jul 1, 2009
• Actual Primary Completion Date: Aug 1, 2011
• Actual Study Completion Date: Aug 1, 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Hernia Recurrence or Surgical Site Infection Requiring Wound Opening [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 [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 [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 [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 [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

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

	Site	City	State	Country	Postal Code
1	University of Kentucky	Lexington	Kentucky	United States	40536
2	Albany Medical College	Albany	New York	United States	12208
3	Greenville Hospital System	Greenville	South Carolina	United States	29605

Sponsors and Collaborators

• Medtronic - MITG

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medtronic - MITG
• ClinicalTrials.gov Identifier: NCT00820040
• Other Study ID Numbers: Hern06R2
• First Posted: Jan 9, 2009
• Last Update Posted: Dec 9, 2020
• Last Verified: Nov 1, 2020

• Keywords provided by Medtronic - MITG: Hernia; Contaminated Field; Mesh Removal; infected mesh removal
• Additional relevant MeSH terms: Hernia

Study Results

Participant Flow

Recruitment Details	Subjects diagnosed with infected prosthetic mesh who were scheduled to undergo planned removal of the mesh were assessed for potential study eligibility. Subjects needed to fulfill all inclusion criteria and no exclusion criteria to be enrolled into the study.
Pre-assignment Detail	One subject was considered a screen failure due to undergoing chemotherapy for an active malignancy within a year prior to the screening visit.

Arm/Group Title	Permacol
Arm/Group Description	acellular porcine dermal collagen mesh: porcine mesh for hernia repair/ abdominal wall reconstruction after removal of infected prosthetic mesh
Period Title: Overall Study
STARTED	10
Safety Evaluable Population	8
Full Analysis Set	8
COMPLETED	7
NOT COMPLETED	3

Baseline Characteristics

Arm/Group Title	Permacol
Arm/Group Description	acellular porcine dermal collagen mesh: porcine mesh for hernia repair/ abdominal wall reconstruction after removal of infected prosthetic mesh
Overall Participants	8
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	58.0 (13.35)
Sex: Female, Male (Count of Participants)
Female	3 37.5%
Male	5 62.5%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	8 100%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	8 100%
Weight (lb) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [lb]	253.1 (55.92)
Height (inches) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [inches]	70.0 (5.58)
BMI (kg/m²) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m²]	36.91 (7.812)
Employment Status (participants) [Number]
Disability/Sick Leave	4 50%
Full Time	2 25%
Missing	2 25%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Hernia recurrence and Surgical Site Infection Requiring Wound Opening for one subject could not be assessed due to death unrelated to the study device. The subject died 19 days post-operatively and therefore primary endpoints assessed at 12 month visit were reported as missing.

Arm/Group Title	Permacol
Arm/Group Description	acellular porcine dermal collagen mesh: porcine mesh for hernia repair/ abdominal wall reconstruction after removal of infected prosthetic mesh
Measure Participants	8
No Hernia Recurrence or Surgical Site Infection Requiring Wound Opening	7 87.5%
Missing	1 12.5%

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Permacol
Arm/Group Description	acellular porcine dermal collagen mesh: porcine mesh for hernia repair/ abdominal wall reconstruction after removal of infected prosthetic mesh
Measure Participants	8
None Reported	8 100%
Reported	0 0%

3. Other Pre-specified Outcome

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

Outcome Measure Data

Analysis Population Description

At baseline eight subjects completed the questionnaire and at 12 months there were seven subjects who completed the questionnaire due to the death of one patient.

Arm/Group Title	Permacol
Arm/Group Description	acellular porcine dermal collagen mesh: porcine mesh for hernia repair/ abdominal wall reconstruction after removal of infected prosthetic mesh
Measure Participants	7
Physical Functioning	12.37 (16.292)
Role Physical	10.28 (7.271)
Bodily Pain	7.73 (14.194)
General Health	-0.57 (6.953)
Social Functioning	8.90 (10.270)
Role Emotional	11.14 (16.000)
Vitality	2.81 (14.715)
Mental Health	4.92 (9.027)
Physical Component Score	7.96 (10.167)
Mental Component Score	5.42 (8.769)

4. Other Pre-specified Outcome

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

Outcome Measure Data

Analysis Population Description

At baseline eight subjects completed the questionnaire and at 12 months there were seven subjects who completed the questionnaire due to the death of one patient.

Arm/Group Title	Permacol
Arm/Group Description	acellular porcine dermal collagen mesh: porcine mesh for hernia repair/ abdominal wall reconstruction after removal of infected prosthetic mesh
Measure Participants	8
Physical Functioning	37.39 (10.304)
Role Physical	37.36 (7.417)
Bodily Pain	39.69 (12.754)
General Health	44.52 (13.225)
Social Functioning	41.34 (12.352)
Role Emotional	35.49 (14.437)
Vitality	47.84 (11.075)
Mental Health	46.28 (10.814)
Physical Component Score	39.18 (8.947)
Mental Component Score	44.61 (9.849)

5. Other Pre-specified Outcome

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

Outcome Measure Data

Analysis Population Description

At baseline eight subjects completed the questionnaire and at 12 months there were seven subjects who completed the questionnaire due to the death of one patient.

Arm/Group Title	Permacol
Arm/Group Description	acellular porcine dermal collagen mesh: porcine mesh for hernia repair/ abdominal wall reconstruction after removal of infected prosthetic mesh
Measure Participants	7
Physical Functioning	49.19 (11.130)
Role Physical	47.19 (12.422)
Bodily Pain	47.42 (12.134)
General Health	45.48 (12.223)
Social Functioning	50.55 (9.895)
Role Emotional	46.63 (16.00)
Vitality	50.47 (10.514)
Mental Health	51.92 (12.581)
Physical Component Score	46.96 (7.822)
Mental Component Score	50.58 (12.289)

Adverse Events

Time Frame	12-months
Adverse Event Reporting Description	All adverse events (AEs) were coded using the Medical Dictionary of Regulatory Activities (MedDRA) Version 12.1. AEs with a definite, possible, or unable to determine relationship are considered to be related to Permacol™ surgical implant.
Arm/Group Title	Permacol
Arm/Group Description	acellular porcine dermal collagen mesh: porcine mesh for hernia repair/ abdominal wall reconstruction after removal of infected prosthetic mesh
All Cause Mortality
	Permacol
	Affected / at Risk (%)	# Events
Total	1/8 (12.5%)
Serious Adverse Events
	Permacol
	Affected / at Risk (%)	# Events
Total	4/8 (50%)
Cardiac disorders
Tachycardia	1/8 (12.5%)	1
Cardiopulmonary Failure	1/8 (12.5%)	1
Reproductive system and breast disorders
Left epididymal orchitis with scrotal edema	1/8 (12.5%)	1
Skin and subcutaneous tissue disorders
Skin Rash	1/8 (12.5%)	1
Other (Not Including Serious) Adverse Events
	Permacol
	Affected / at Risk (%)	# Events
Total	7/8 (87.5%)
Blood and lymphatic system disorders
Anemia	1/8 (12.5%)	1
Cardiac disorders
Atrial fibrillation	1/8 (12.5%)	1
Tachycardia	1/8 (12.5%)	1
Gastrointestinal disorders
Abdominal pain	1/8 (12.5%)	1
Abdominal pain upper	1/8 (12.5%)	1
Abdominal tenderness	1/8 (12.5%)	1
Nausea	1/8 (12.5%)	1
Oropharyngeal blistering	1/8 (12.5%)	1
Vomiting	2/8 (25%)	2
General disorders
Adverse drug reaction	1/8 (12.5%)	1
Oedema peripheral	1/8 (12.5%)	1
Pyrexia	2/8 (25%)	2
Infections and infestations
Abdominal abscess	1/8 (12.5%)	1
Onychomycosis	1/8 (12.5%)	1
Staphylococcal infection	1/8 (12.5%)	1
Injury, poisoning and procedural complications
Incision site pain	1/8 (12.5%)	1
Postoperative ileus	1/8 (12.5%)	1
Investigations
Blood pressure decreased	1/8 (12.5%)	1
Metabolism and nutrition disorders
Dehydration	1/8 (12.5%)	1
Decreased appetite	1/8 (12.5%)	1
Hypokalaemia	1/8 (12.5%)	1
Hypomagnesaemia	1/8 (12.5%)	1
Hypophosphataemia	1/8 (12.5%)	1
Nervous system disorders
Incontinence	1/8 (12.5%)	1
Urinary incontinence	1/8 (12.5%)	1
Psychiatric disorders
Agitation	1/8 (12.5%)	1
Delirium	1/8 (12.5%)	1
Renal and urinary disorders
Dysuria	1/8 (12.5%)	1
Renal failure acute	1/8 (12.5%)	1
Urinary tract infection	1/8 (12.5%)	1
Respiratory, thoracic and mediastinal disorders
Respiratory disorder	2/8 (25%)	2
Skin and subcutaneous tissue disorders
Ichthyosis	1/8 (12.5%)	1
Vascular disorders
Hypertension	1/8 (12.5%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.