Feasibility of Permacol Use in Infected Fields

NCT00820040 | Terminated Phase 2 Results

• 1 other identifier: Hern06R2
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 3

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

Conditions

Hernia

Keywords

Hernia; Contaminated Field; Mesh Removal; infected mesh removal

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (1)

• Subjects Having Permacol Implants Removed or Debrided After Implantation

  12 months

Other Outcomes (3)

• Physical and Other Examinations

  12-month post-procedure change from baseline

• Physical and Other Examinations

  Baseline

• Physical and Other Examinations

  12-month post-procedure

Study Arms (1)

Permacol

EXPERIMENTAL

Device: acellular porcine dermal collagen mesh

Interventions

acellular porcine dermal collagen mesh DEVICE

porcine mesh for hernia repair/ abdominal wall reconstruction

Also known as: Permacol

Permacol

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic - MITG: lead

Study Sites (3)

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Albany Medical College

Albany, New York, 12208, United States

Location

Greenville Hospital System

Greenville, South Carolina, 29605, United States

Location

MeSH Terms

Conditions

Hernia

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Heather McManus
• Organization: Medtronic

heather.mcmanus@medtronic.com

2038213323

Study Officials

• John Roth, MD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2009
• First Posted: January 9, 2009
• Study Start: July 1, 2009
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: December 9, 2020
• Results First Posted: December 9, 2020

Record last verified: 2020-11

Locations

US (3)