TerminatedNCT00820040Updated Dec 9, 2020Results posted

Feasibility of Permacol Use in Infected Fields

A Phase 2 interventional study of acellular porcine dermal collagen mesh in Hernia, sponsored by Medtronic - MITG. Terminated at 3 sites in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2020-12-09.

Sponsored by Medtronic - MITG · Phase 2, Interventional, and Treatment

Why this study was terminated

Slow enrollment due to strict eligibility criteria

Phase: Phase 2
Study type: Interventional
Enrollment: 10
Allocation: Not applicable
Ages: 18 Years to 85 Years
Sex: All

Study 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

Conditions studied

Hernia

Browse trials for

Hernia 1,096

Keywords

Hernia
Contaminated Field
Mesh Removal
infected mesh removal

In context

Hernia

1,096 studies on the registry are indexed under Hernia; 132 are open to participants now.

This study's enrollment of 10 is below the median of 80 across 739 interventional studies indexed under Hernia.

Browse Hernia studies →

Lead sponsor

Medtronic - MITG is the lead sponsor of 176 studies on the registry; 5 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 17 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 85 Years
Sexes eligible: 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

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

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 10 participants (actual)

Study arms

Experimental
Permacol
Device: acellular porcine dermal collagen mesh

Interventions

Deviceacellular porcine dermal collagen mesh
porcine mesh for hernia repair/ abdominal wall reconstruction
Also known as: Permacol

What researchers measure

Primary outcomes

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.
Time frame: 12 months

Secondary outcomes

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.
Time frame: 12 months

Other outcomes

Physical and Other Examinations
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
Physical and Other Examinations
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
Physical and Other Examinations
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

Results

Posted Dec 9, 2020

Participant flow

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.

Participant flow — Overall Study
Milestone	Permacol
Started	10
Safety evaluable population	8
Full analysis set	8
Completed	7
Not completed	3
Withdrew: Death	1
Withdrew: Sponsor terminated study	1
Withdrew: Screen failure	1

Outcome measures

PrimaryNumber 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.

Time frame:: 12 months
Reported as:: Count of participants · Participants

Number of Participants With Hernia Recurrence or Surgical Site Infection Requiring Wound Opening
Participants	Permacol
No Hernia Recurrence or Surgical Site Infection Requiring Wound Opening	7
Missing	1

SecondarySubjects 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.

Time frame:: 12 months
Reported as:: Count of participants · Participants

Subjects Having Permacol Implants Removed or Debrided After Implantation
Participants	Permacol
None Reported	8
Reported	0

Other pre-specifiedPhysical and Other Examinations

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
Reported as:: Mean · score on a scale

Physical and Other Examinations
score on a scale	Permacol
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

Other pre-specifiedPhysical and Other Examinations

Time frame:: Baseline
Reported as:: Mean · score on a scale

Physical and Other Examinations
score on a scale	Permacol
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

Other pre-specifiedPhysical and Other Examinations

Time frame:: 12-month post-procedure
Reported as:: Mean · score on a scale

Physical and Other Examinations
score on a scale	Permacol
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

Collected over 12-months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Permacol	1/8 (12.5%)	4/8 (50%)	7/8 (87.5%)

Most frequent serious events

Most frequent serious events
Event	Permacol
Skin RashSkin and subcutaneous tissue disorders	1/8
TachycardiaCardiac disorders	1/8
Cardiopulmonary FailureCardiac disorders	1/8
Left epididymal orchitis with scrotal edemaReproductive system and breast disorders	1/8

Most frequent other events

Showing 10 of 33

Most frequent other events
Event	Permacol
VomitingGastrointestinal disorders	2/8
PyrexiaGeneral disorders	2/8
Respiratory disorderRespiratory, thoracic and mediastinal disorders	2/8
AnemiaBlood and lymphatic system disorders	1/8
Atrial fibrillationCardiac disorders	1/8
TachycardiaCardiac disorders	1/8
DehydrationMetabolism and nutrition disorders	1/8
Abdominal painGastrointestinal disorders	1/8
Abdominal pain upperGastrointestinal disorders	1/8
Abdominal tendernessGastrointestinal disorders	1/8

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Permacol
Mean	58.0 ± 13.35

Sex: Female, Male
Sex: Female, Male(Participants)	Permacol
Female	3
Male	5

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Permacol
American Indian or Alaska Native	0
Asian	0
Native Hawaiian or Other Pacific Islander	0
Black or African American	0
White	8
More than one race	0
Unknown or Not Reported	0

Region of Enrollment
Region of Enrollment(participants)	Permacol
United States	8

Weight
Weight(lb)	Permacol
Mean	253.1 ± 55.92

Height
Height(inches)	Permacol
Mean	70.0 ± 5.58

BMI
BMI(kg/m²)	Permacol
Mean	36.91 ± 7.812

Employment Status
Employment Status(participants)	Permacol
Disability/Sick Leave	4
Full Time	2
Missing	2

Study locations

3 sites

University of Kentucky
Lexington, Kentucky 40536, United States
Albany Medical College
Albany, New York 12208, United States
Greenville Hospital System
Greenville, South Carolina 29605, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Dec 9, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00820040
Lead sponsor: Medtronic - MITG
Responsible party: Sponsor
First posted: Jan 9, 2009
Start date: Jul 2009
Primary completion: Aug 2011
Completion: Aug 2011
Results posted: Dec 9, 2020
Last update: Dec 9, 2020

Study contacts

John Roth, MD

principal investigator · University of Kentucky

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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Feasibility of Permacol Use in Infected Fields

Study summary

Conditions studied

Browse trials for

Keywords

In context

Hernia

Lead sponsor

Who can participate

✓Inclusion criteria

✕Exclusion criteria

Study design

Study arms

Interventions

What researchers measure

Primary outcomes

Secondary outcomes

Other outcomes

Results

Participant flow

Outcome measures

Adverse events

Baseline characteristics

Study locations

Updates

Registry details

Key details

Study contacts

Oversight

Not currently enrolling

Follow this study

Discussion

Other studies in this condition

Other studies from this sponsor

Inclusion criteria

Exclusion criteria