Antimicrobial Hernia Repair Device
Primary Purpose
Ventral Hernias, Incisional Hernias
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Antimicrobial Hernia Repair Device
Sponsored by
About this trial
This is an interventional treatment trial for Ventral Hernias
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Antimicrobial Hernia Repair Device
Arm Description
Antimicrobial hernia repair device for repair of ventral or incisional hernias in Class II and III surgical fields.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT02730936
First Posted
March 30, 2016
Last Updated
February 10, 2017
Sponsor
Cook Group Incorporated
1. Study Identification
Unique Protocol Identification Number
NCT02730936
Brief Title
Antimicrobial Hernia Repair Device
Official Title
Feasibility Study of the Antimicrobial Hernia Repair Device for Repair of Ventral or Incisional Hernia
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Sponsor decision to discontinue the study.
Study Start Date
January 12, 2016 (Anticipated)
Primary Completion Date
July 2018 (Anticipated)
Study Completion Date
July 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cook Group Incorporated
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventral Hernias, Incisional Hernias
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Antimicrobial Hernia Repair Device
Arm Type
Experimental
Arm Description
Antimicrobial hernia repair device for repair of ventral or incisional hernias in Class II and III surgical fields.
Intervention Type
Device
Intervention Name(s)
Antimicrobial Hernia Repair Device
Intervention Description
hernia repair
Primary Outcome Measure Information:
Title
Number of patients that develop a surgical site infection
Description
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 Outcome Measure Information:
Title
Number of hernia recurrences
Description
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
Title
Frequency of procedural and post-operative adverse events
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
12. IPD Sharing Statement
Learn more about this trial
Antimicrobial Hernia Repair Device
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