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 Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Hernia
• Intervention: Device: acellular porcine dermal collagen mesh
• Enrollment: 10

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 Details	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
Reason Not Completed
Death	1
Sponsor terminated study	1
Screen failure	1

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 Number of Baseline Participants		8
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	8 participants
		58.0 (13.35)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	8 participants
	Female	3 37.5%
	Male	5 62.5%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	8 participants
	American Indian or Alaska Native	0 0.0%
	Asian	0 0.0%
	Native Hawaiian or Other Pacific Islander	0 0.0%
	Black or African American	0 0.0%
	White	8 100.0%
	More than one race	0 0.0%
	Unknown or Not Reported	0 0.0%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	8 participants
		8
Weight; Mean (Standard Deviation); Unit of measure: Lb
	Number Analyzed	8 participants
		253.1 (55.92)
Height; Mean (Standard Deviation); Unit of measure: Inches
	Number Analyzed	8 participants
		70.0 (5.58)
BMI; Mean (Standard Deviation); Unit of measure: Kg/m²
	Number Analyzed	8 participants
		36.91 (7.812)
Employment Status; Measure Type: Number; Unit of measure: Participants	Number Analyzed	8 participants
Disability/Sick Leave		4
Full Time		2
Missing		2

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
Overall Number of Participants Analyzed	8
Measure Type: Count of Participants; Unit of Measure: Participants
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
Overall Number of Participants Analyzed	8
Measure Type: Count of Participants; Unit of Measure: Participants
None Reported	8 100.0%
Reported	0 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
Overall Number of Participants Analyzed	7
Mean (Standard Deviation); Unit of Measure: score on a scale
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
Overall Number of Participants Analyzed	8
Mean (Standard Deviation); Unit of Measure: score on a scale
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
Overall Number of Participants Analyzed	7
Mean (Standard Deviation); Unit of Measure: score on a scale
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 (%)
Total	1/8 (12.50%)
Serious Adverse Events
	Permacol
	Affected / at Risk (%)	# Events
Total	4/8 (50.00%)
Cardiac disorders
Tachycardia † 1 [1]	1/8 (12.50%)	1
Cardiopulmonary Failure † 1 [2]	1/8 (12.50%)	1
Reproductive system and breast disorders
Left epididymal orchitis with scrotal edema † 1 [3]	1/8 (12.50%)	1
Skin and subcutaneous tissue disorders
Skin Rash † 1 [4]	1/8 (12.50%)	1
1 Term from vocabulary, MedDRA 12.1; † Indicates events were collected by systematic assessment; [1] Categorized as possibly related to Permacol™ surgical implant and procedure. The event resolved two days after onset and did not occur again throughout the study.; [2] Categorized as unknown relation to procedure and no relation to device.; [3] Categorized as not related to procedure or device and was ongoing at the time of study closure.; [4] Considered not related to procedure or device. It was later determined that the event was related to antibiotic medication.
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Permacol
	Affected / at Risk (%)	# Events
Total	7/8 (87.50%)
Blood and lymphatic system disorders
Anemia † 1	1/8 (12.50%)	1
Cardiac disorders
Atrial fibrillation † 1	1/8 (12.50%)	1
Tachycardia † 1	1/8 (12.50%)	1
Gastrointestinal disorders
Abdominal pain † 1	1/8 (12.50%)	1
Abdominal pain upper † 1	1/8 (12.50%)	1
Abdominal tenderness † 1	1/8 (12.50%)	1
Nausea † 1	1/8 (12.50%)	1
Oropharyngeal blistering † 1	1/8 (12.50%)	1
Vomiting † 1	2/8 (25.00%)	2
General disorders
Adverse drug reaction † 1	1/8 (12.50%)	1
Oedema peripheral † 1	1/8 (12.50%)	1
Pyrexia † 1	2/8 (25.00%)	2
Infections and infestations
Abdominal abscess † 1	1/8 (12.50%)	1
Onychomycosis † 1	1/8 (12.50%)	1
Staphylococcal infection † 1	1/8 (12.50%)	1
Injury, poisoning and procedural complications
Incision site pain † 1	1/8 (12.50%)	1
Postoperative ileus † 1	1/8 (12.50%)	1
Investigations
Blood pressure decreased † 1	1/8 (12.50%)	1
Metabolism and nutrition disorders
Dehydration † 1	1/8 (12.50%)	1
Decreased appetite † 1	1/8 (12.50%)	1
Hypokalaemia † 1	1/8 (12.50%)	1
Hypomagnesaemia † 1	1/8 (12.50%)	1
Hypophosphataemia † 1	1/8 (12.50%)	1
Nervous system disorders
Incontinence † 1	1/8 (12.50%)	1
Urinary incontinence † 1	1/8 (12.50%)	1
Psychiatric disorders
Agitation † 1	1/8 (12.50%)	1
Delirium † 1	1/8 (12.50%)	1
Renal and urinary disorders
Dysuria † 1	1/8 (12.50%)	1
Renal failure acute † 1	1/8 (12.50%)	1
Urinary tract infection † 1	1/8 (12.50%)	1
Respiratory, thoracic and mediastinal disorders
Respiratory disorder † 1	2/8 (25.00%)	2
Skin and subcutaneous tissue disorders
Ichthyosis † 1	1/8 (12.50%)	1
Vascular disorders
Hypertension † 1	1/8 (12.50%)	1
1 Term from vocabulary, MedDRA 12.1; † Indicates events were collected by systematic assessment

Limitations and 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.

Results Point of Contact

• Name/Title: Heather McManus
• Organization: Medtronic
• Phone: 2038213323
• EMail: heather.mcmanus@medtronic.com

• Responsible Party: Medtronic - MITG
• ClinicalTrials.gov Identifier: NCT00820040
• Other Study ID Numbers: Hern06R2
• First Submitted: January 7, 2009
• First Posted: January 9, 2009
• Results First Submitted: September 29, 2020
• Results First Posted: December 9, 2020
• Last Update Posted: December 9, 2020