Antimicrobial Hernia Repair Device Clinical Study
AMEX
Feasibility Study of the Antimicrobial Hernia Repair Device for Repair of Ventral or Incisional Hernia
1 other identifier
interventional
24
2 countries
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2015
Typical duration for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 24, 2015
CompletedFirst Posted
Study publicly available on registry
March 27, 2015
CompletedStudy Start
First participant enrolled
June 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 25, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 25, 2018
CompletedFebruary 15, 2018
February 1, 2018
2.7 years
March 24, 2015
February 14, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of Surgical Site Infection
6 months
Secondary Outcomes (1)
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).
12 months
Study Arms (1)
Hernia Repair
EXPERIMENTALSurgical repair for hernia with implantation of the Cook® Antimicrobial Hernia Repair Device.
Interventions
Device containing an antimicrobial to reinforce soft tissue during ventral or incisional hernia repair in clean-contaminated, contaminated, and dirty-infected
Eligibility Criteria
You may qualify if:
- Patient presents with a ventral or incisional hernia that is to be surgically corrected using open repair technique
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6, Canada
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, B3H 2Y9, Canada
Salford Royal Hospital
Salford, England, M68HD, United Kingdom
Royal Liverpool Hospital
Liverpool, L7 8XP, United Kingdom
Related Publications (1)
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.
PMID: 32228664DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 24, 2015
First Posted
March 27, 2015
Study Start
June 1, 2015
Primary Completion
January 25, 2018
Study Completion
January 25, 2018
Last Updated
February 15, 2018
Record last verified: 2018-02