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Feasibility of Permacol Use in Infected Fields

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ClinicalTrials.gov Identifier: NCT00820040
Recruitment Status : Terminated (Slow enrollment due to strict eligibility criteria)
First Posted : January 9, 2009
Results First Posted : December 9, 2020
Last Update Posted : December 9, 2020
Sponsor:
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
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
Hide 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
Arm/Group Title Permacol
Hide 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
Hide 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
1.Primary Outcome
Title Number of Participants With Hernia Recurrence or Surgical Site Infection Requiring Wound Opening
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Permacol
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
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
Hide 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%)    
Hide 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.
Hide 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
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
Layout table for Results Point of Contact information
Name/Title: Heather McManus
Organization: Medtronic
Phone: 2038213323
EMail: heather.mcmanus@medtronic.com
Layout table for additonal information
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