Antimicrobial Hernia Repair Device Clinical Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2018-01-25

Brief Summary

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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.

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Detailed Description

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Conditions

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Ventral Hernia Incisional Hernia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hernia Repair

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

Group Type EXPERIMENTAL

Cook® Antimicrobial Hernia Repair Device

Intervention Type DEVICE

Device containing an antimicrobial to reinforce soft tissue during ventral or incisional hernia repair in clean-contaminated, contaminated, and dirty-infected

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No