Antimicrobial Hernia Repair Device

Not Applicable

Withdrawn

• Conditions: Ventral Hernias; Incisional Hernias
• Interventions: Device: Antimicrobial Hernia Repair Device

• Registration Number: NCT02730936
• Lead Sponsor: Cook Group Incorporated

Brief Summary

This prospective early feasibility clinical study will collect information regarding the safety and efficacy of the Cook® Antimicrobial Hernia Repair Device to reinforce soft tissue during ventral or incisional hernia repair in clean-contaminated and contaminated (i.e., Class II and Class III) surgical fields.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-12
• Study First Submitted: 2016-03-30
• Study First Submitted QC: 2016-04-01
• Study First Posted: 2016-04-07
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-10
• Last Update Posted: 2017-02-13
• Primary Completion: 2018-07
• Study Completion: 2020-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Patient with ventral or incisional hernia that is to be surgically corrected in a Class II and Class III surgical field.

Exclusion Criteria

• Less than 21 years old
• Unwilling or unable to sign and date the informed consent
• Pregnant, breastfeeding, or planning to become pregnant prior to completing the study
• Unable or unwilling to comply with follow-up schedule
• Simultaneously participating in another investigational drug or device study.
• Medical condition or disorder that would limit life expectancy to less than the primary clinical study endpoint.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Antimicrobial Hernia Repair Device	Antimicrobial Hernia Repair Device	Antimicrobial hernia repair device for repair of ventral or incisional hernias in Class II and III surgical fields.

Primary Outcome Measures

Name	Time	Method
Number of patients that develop a surgical site infection	6 months	Surgical site infections (SSI) that will be included in this outcome measure are deep incisional, organ/space, and superficial incisional.

Secondary Outcome Measures

Name	Time	Method
Frequency of procedural and post-operative adverse events	24 months	The adverse events will be bowel erosion, bowl obstruction, delayed wound infection, fever, fistula formation, graft contraction, hernia recurrence, ileus, need for revision/resurgery, pain, premature degradation, wound dehiscence, and other wound complications.
Number of hernia recurrences	24 months	Hernia recurrences is the protrusion of abdominal tissue through a defect in the abdominal wall at the site of the hernia repaired during the index procedure.