Antimicrobial Hernia Repair Device

Cook Group Incorporated

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

Ventral Hernias Incisional Hernias

Interventions

Antimicrobial Hernia Repair DeviceDEVICE

hernia repair

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 6 months

Secondary Outcomes

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.

Time frame: 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.

Time frame: 24 months

Data from ClinicalTrials.gov

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