Antimicrobial Hernia Repair Device Clinical Study

Ventral Hernia Clinical Trial

— AMEX  

Official title:

Feasibility Study of the Antimicrobial Hernia Repair Device for Repair of Ventral or Incisional Hernia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02401334
• Other study ID #: 13-10
• Status: Completed
• Phase: N/A
• First received: March 24, 2015
• Last updated: February 14, 2018
• Start date: June 2015
• Est. completion date: January 25, 2018

Study information

• Verified date: February 2018
• Source: Cook Group Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: January 25, 2018
• Est. primary completion date: January 25, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Ventral
• Incisional Hernia
• Ventral Hernia

Intervention

Device:
• Cook® Antimicrobial Hernia Repair Device
Device containing an antimicrobial to reinforce soft tissue during ventral or incisional hernia repair in clean-contaminated, contaminated, and dirty-infected

Locations

Country	Name	City	State
Canada	Queen Elizabeth II Health Sciences Centre	Halifax	Nova Scotia
Canada	St. Paul's Hospital	Vancouver	British Columbia
United Kingdom	Royal Liverpool Hospital	Liverpool
United Kingdom	Salford Royal Hospital	Salford	England

Sponsors (1)

Lead Sponsor	Collaborator
Cook Group Incorporated

Countries where clinical trial is conducted

Canada,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Surgical Site Infection		6 months
Secondary	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