Antimicrobial Hernia Repair Device

Not Applicable

Withdrawn

• Conditions: Ventral Hernias; Incisional Hernias

• 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• Status: WITHDRAWN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

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.