Back to resultsMesh Type in Ventral Hernia Repair
Primary Purpose
Ventral Hernia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Synthetic Mesh
Biologic Mesh
Sponsored by
About this trial
This is an interventional treatment trial for Ventral Hernia focused on measuring ventral hernia, mesh
Eligibility Criteria
Inclusion Criteria:
- Patient scheduled for open ventral hernia repair at LBJ General Hospital
Exclusion Criteria:
- Active infection
- Patient unlikely to survive with the next 2 years based upon surgeon judgment (i.e. metastatic cancer, end-stage cirrhosis)
- Patient surgeon would not normally place a prosthetic (e.g. planned second surgery such as ostomy takedown)
- Patient unlikely to follow-up (i.e. no phone)
Sites / Locations
- UT Health at Lyndon B. Johnson General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Synthetic Mesh
Biologic Mesh
Arm Description
Synthetic mesh (mid-density polypropylene (generic) Bard soft mesh) will be used in open ventral hernia repair
Biologic mesh (non cross linked porcine acellular dermal matrix: Strattice) will be used in open ventral hernia repair
Outcomes
Primary Outcome Measures
Complication free at 1 year post-operative
Complication defined as hernia recurrence, chronic wound complications including mesh infection, and reoperation
Secondary Outcome Measures
Complication free at 3 years post-operative
Complication defined as hernia recurrence, chronic wound complications including mesh infection, and reoperation
Dindo-clavien complications
Grade I to V
Patient centered outcomes
includes patient satisfaction, cosmetic satisfaction, modified assessment scale
Cost
charges for all patient visits, admissions, and procedures
Full Information
NCT ID
NCT03091790
First Posted
March 21, 2017
Last Updated
June 20, 2023
Sponsor
The University of Texas Health Science Center, Houston
1. Study Identification
Unique Protocol Identification Number
NCT03091790
Brief Title
Mesh Type in Ventral Hernia Repair
Official Title
Mesh Type in Ventral Hernia Repair
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
March 27, 2017 (Actual)
Primary Completion Date
July 26, 2020 (Actual)
Study Completion Date
July 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Ventral hernias are common following abdominal surgery. Currently, there is no equipoise on when synthetic and biologic meshes should be used. Among open ventral hernia repairs, half are repaired using biologic mesh while half are repaired using synthetic mesh. The investigators hypothesize that biologic mesh as opposed to synthetic mesh repair of open ventral hernia repair is associated with decreased risk of major complications one year after surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventral Hernia
Keywords
ventral hernia, mesh
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
87 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Synthetic Mesh
Arm Type
Active Comparator
Arm Description
Synthetic mesh (mid-density polypropylene (generic) Bard soft mesh) will be used in open ventral hernia repair
Arm Title
Biologic Mesh
Arm Type
Active Comparator
Arm Description
Biologic mesh (non cross linked porcine acellular dermal matrix: Strattice) will be used in open ventral hernia repair
Intervention Type
Device
Intervention Name(s)
Synthetic Mesh
Intervention Description
Synthetic mesh used during open ventral hernia repair
Intervention Type
Device
Intervention Name(s)
Biologic Mesh
Intervention Description
Biologic mesh used during open ventral hernia repair
Primary Outcome Measure Information:
Title
Complication free at 1 year post-operative
Description
Complication defined as hernia recurrence, chronic wound complications including mesh infection, and reoperation
Time Frame
1 year after surgery
Secondary Outcome Measure Information:
Title
Complication free at 3 years post-operative
Description
Complication defined as hernia recurrence, chronic wound complications including mesh infection, and reoperation
Time Frame
3 years after surgery
Title
Dindo-clavien complications
Description
Grade I to V
Time Frame
Pre-operative, 1 month after surgery, 1 year and 3 years after surgery
Title
Patient centered outcomes
Description
includes patient satisfaction, cosmetic satisfaction, modified assessment scale
Time Frame
Pre-operative, 1 month after surgery, 1 year and 3 years after surgery
Title
Cost
Description
charges for all patient visits, admissions, and procedures
Time Frame
1 year and 3 years after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient scheduled for open ventral hernia repair at LBJ General Hospital
Exclusion Criteria:
Active infection
Patient unlikely to survive with the next 2 years based upon surgeon judgment (i.e. metastatic cancer, end-stage cirrhosis)
Patient surgeon would not normally place a prosthetic (e.g. planned second surgery such as ostomy takedown)
Patient unlikely to follow-up (i.e. no phone)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie L Holihan, M.D.
Organizational Affiliation
UT Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
UT Health at Lyndon B. Johnson General Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77026
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Mesh Type in Ventral Hernia Repair
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