Antimicrobial Hernia Repair Device

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Incisional Hernias; Ventral Hernias
• Intervention / Treatment: Device: Antimicrobial Hernia Repair Device

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Antimicrobial Hernia Repair Device; Antimicrobial hernia repair device for repair of ventral or incisional hernias in Class II and III surgical fields.	Device: Antimicrobial Hernia Repair Device; hernia repair

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of hernia recurrences	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.	24 months
Frequency of procedural and post-operative adverse events	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.	24 months

Collaborators and Investigators

• Sponsor: Cook Group Incorporated

Study record dates

Study Major Dates

• Study Start (Anticipated): January 12, 2016
• Primary Completion (Anticipated): July 1, 2018
• Study Completion (Anticipated): July 1, 2020

Study Registration Dates

• First Submitted: March 30, 2016
• First Submitted That Met QC Criteria: April 1, 2016
• First Posted (Estimate): April 7, 2016

Study Record Updates

• Last Update Posted (Actual): February 13, 2017
• Last Update Submitted That Met QC Criteria: February 10, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Ventral; Incisional Hernia; Anti-Bacterial Agents; Anti-Infective Agents
• Other Study ID Numbers: 14-12

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes