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Antimicrobial Hernia Repair Device Clinical Study (AMEX)

Primary Purpose

Ventral Hernia, Incisional Hernia

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Cook® Antimicrobial Hernia Repair Device
Sponsored by
Cook Group Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ventral Hernia

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient presents with a ventral or incisional hernia that is to be surgically corrected using open repair technique

Exclusion Criteria:

  • Body Mass Index (BMI) < 25.
  • Body weight < 45 kg
  • Glycosylated Hemoglobin (Hgb A1c) > 10%
  • Albumin < 2.5 g/dL or pre-albumin < 5.0 mg/dL
  • Renal insufficiency, as determined by an estimated glomerular filtration rate (GFR) < 60 mL/min/1.73 m2
  • Known allergies to study device components
  • Other relevant exclusion criteria apply

Sites / Locations

  • St. Paul's Hospital
  • Queen Elizabeth II Health Sciences Centre
  • Salford Royal Hospital
  • Royal Liverpool Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hernia Repair

Arm Description

Surgical repair for hernia with implantation of the Cook® Antimicrobial Hernia Repair Device.

Outcomes

Primary Outcome Measures

Incidence of Surgical Site Infection

Secondary Outcome Measures

Incidence of procedural or post-operative adverse events related to the study device or procedure (i.e., Permanence of hernia repair, as determined by hernia recurrence).

Full Information

First Posted
March 24, 2015
Last Updated
February 14, 2018
Sponsor
Cook Group Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT02401334
Brief Title
Antimicrobial Hernia Repair Device Clinical Study
Acronym
AMEX
Official Title
Feasibility Study of the Antimicrobial Hernia Repair Device for Repair of Ventral or Incisional Hernia
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
January 25, 2018 (Actual)
Study Completion Date
January 25, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cook Group Incorporated

4. Oversight

5. Study Description

Brief Summary
This prospective clinical study will evaluate the safety and efficacy of the Cook® Antimicrobial Hernia Repair Device containing an antimicrobial to reinforce soft tissue during ventral or incisional hernia repair in clean-contaminated, contaminated, and dirty-infected (i.e., Class II, Class III, and Class IV) surgical fields. Up to 30 patients will be treated with the Cook® Antimicrobial Hernia Repair Device and patients will be followed for 12 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventral Hernia, Incisional Hernia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hernia Repair
Arm Type
Experimental
Arm Description
Surgical repair for hernia with implantation of the Cook® Antimicrobial Hernia Repair Device.
Intervention Type
Device
Intervention Name(s)
Cook® Antimicrobial Hernia Repair Device
Intervention Description
Device containing an antimicrobial to reinforce soft tissue during ventral or incisional hernia repair in clean-contaminated, contaminated, and dirty-infected
Primary Outcome Measure Information:
Title
Incidence of Surgical Site Infection
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Incidence of procedural or post-operative adverse events related to the study device or procedure (i.e., Permanence of hernia repair, as determined by hernia recurrence).
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient presents with a ventral or incisional hernia that is to be surgically corrected using open repair technique Exclusion Criteria: Body Mass Index (BMI) < 25. Body weight < 45 kg Glycosylated Hemoglobin (Hgb A1c) > 10% Albumin < 2.5 g/dL or pre-albumin < 5.0 mg/dL Renal insufficiency, as determined by an estimated glomerular filtration rate (GFR) < 60 mL/min/1.73 m2 Known allergies to study device components Other relevant exclusion criteria apply
Facility Information:
Facility Name
St. Paul's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada
Facility Name
Queen Elizabeth II Health Sciences Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Facility Name
Salford Royal Hospital
City
Salford
State/Province
England
ZIP/Postal Code
M68HD
Country
United Kingdom
Facility Name
Royal Liverpool Hospital
City
Liverpool
ZIP/Postal Code
L7 8XP
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
32228664
Citation
Minor S, Brown CJ, Rooney PS, Hodde JP, Julien L, Scott TM, Karimuddin AA, Raval MJ, Phang PT. Single-stage repair of contaminated hernias using a novel antibiotic-impregnated biologic porcine submucosa tissue matrix. BMC Surg. 2020 Mar 30;20(1):58. doi: 10.1186/s12893-020-00715-w.
Results Reference
derived

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Antimicrobial Hernia Repair Device Clinical Study

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