HerniaPhase 2NCT00820040

Feasibility of Permacol Use in Infected Fields

A Phase 2 study testing acellular porcine dermal collagen mesh in people with Hernia, run by Medtronic - MITG at 3 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial 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 Read more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Hernia
What is being tested?: acellular porcine dermal collagen mesh
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 3 sitesUnited States
Study dates: Jul 2009to Aug 2011
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Show all 10Show fewer

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

Who cannot join

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

Show all 20Show fewer

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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

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

Other trials in United States

About this study

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

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: Hernia
Being tested: acellular porcine dermal collagen mesh
Keywords: Hernia, Contaminated Field, Mesh Removal, infected mesh removal
Medical subject headings: Hernia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

acellular porcine dermal collagen meshDevice
Also called Permacol
porcine mesh for hernia repair/ abdominal wall reconstruction

Study groups in NCT00820040
Study group	Role	What they receive
Permacol	Experimental	Not described Receives: Device: acellular porcine dermal collagen mesh

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 12 months

Secondary outcomes (1)

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.
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2009Aug 2011

First posted9 Jan 2009 (estimated)
Study startJul 2009
Primary completionAug 2011
Study completionAug 2011

Why it stopped: Slow enrollment due to strict eligibility criteria

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HerniaStudies of the same condition, open and under way.
More trials run by Medtronic - MITGThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

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

IDs, dates and publications

ClinicalTrials.gov ID: NCT00820040
Sponsor's protocol ID: Hern06R2
Status last verified: Nov 2020
First submitted: 7 Jan 2009
Last updated: 9 Dec 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingObservational study
Assessment of GORE® SYNECOR Biomaterial in Focused Patient Populations and Long-Term Application
Hernia, Ventral, Hernia Incisional
Recruiting
Primary Sac Abandonment and Distal Sac Fixation vs Complete Sac Dissection for Inguinoscrotal Hernias
Seroma, Inguinal Hernias
Active, not recruiting
Fetoscopic Endoluminal Tracheal Occlusion in Severe Left Congenital Diaphragmatic Hernia
Congenital Diaphragmatic Hernia, Pulmonary Hypoplasia
Recruiting
Comparing Two Laparoscopic Techniques for Hernia Repair in Children
Inguinal Hernia
Not yet recruiting
Cortical Surface Functional Changes After Lever Positioning Manipulation for Lumbar Disc Herniation
Lumbar Disc Herniation

All Hernia trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00820040
Acronym / sponsor ID: Hern06R2
Conditions: Hernia
Keywords: Hernia, Contaminated Field, Mesh Removal, infected mesh removal
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Slow enrollment due to strict eligibility criteria
Enrolment: 10 participants (actual)
Lead sponsor: Medtronic - MITGIndustry (pharma, biotech, devices)
Study start: Jul 2009
Primary completion: Aug 2011 (actual)
Study completion: Aug 2011 (actual)
First posted: 9 Jan 2009 (estimated)
Results: Posted 9 Dec 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Permacol	Experimental	Device: acellular porcine dermal collagen mesh

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

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

Key exclusion criteria (20 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
acellular porcine dermal collagen meshAlso: Permacolporcine mesh for hernia repair/ abdominal wall reconstruction	Device	Permacol

Primary outcome

Number of Participants With Hernia Recurrence or Surgical Site Infection Requiring Wound Opening
Time frame: 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.

1 secondary outcome

Subjects Having Permacol Implants Removed or Debrided After Implantation
Time frame: 12 months

Results and safety

Results posted to the registry on 9 Dec 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Permacol	10	7

Primary outcome: Number of Participants With Hernia Recurrence or Surgical Site Infection Requiring Wound Opening

Time frame: 12 months. Count of participants. Unit: Participants

Measure	Permacol n = 8
No Hernia Recurrence or Surgical Site Infection Requiring Wound Opening	7
Missing	1

Population analysed: 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.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 12-months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Permacol	4 of 8 (50%)	7 of 8 (87.5%)	1 of 8

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hernia

Active, not recruitingObservational study
Assessment of GORE® SYNECOR Biomaterial in Focused Patient Populations and Long-Term Application
Hernia, Ventral, Hernia Incisional
Recruiting
Primary Sac Abandonment and Distal Sac Fixation vs Complete Sac Dissection for Inguinoscrotal Hernias
Seroma, Inguinal Hernias
Active, not recruiting
Fetoscopic Endoluminal Tracheal Occlusion in Severe Left Congenital Diaphragmatic Hernia
Congenital Diaphragmatic Hernia, Pulmonary Hypoplasia
Recruiting
Comparing Two Laparoscopic Techniques for Hernia Repair in Children
Inguinal Hernia
Not yet recruiting
Cortical Surface Functional Changes After Lever Positioning Manipulation for Lumbar Disc Herniation
Lumbar Disc Herniation

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

John Roth, MD principal investigator

University of Kentucky

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing acellular porcine dermal collagen mesh in people with Hernia, run by Medtronic - MITG at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 9 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Hernia Recurrence or Surgical Site Infection Requiring Wound Opening (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00820040.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2020.