Back to resultsA Comparison of the Outcomes in Fortiva and Strattice Mesh
Primary Purpose
Ventral Hernia
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Propspective VHR with Fortiva
RetroSpective VHR with Strattice
Sponsored by
About this trial
This is an interventional treatment trial for Ventral Hernia focused on measuring ventral hernia, surgical biologic mesh, hernia complications
Eligibility Criteria
Inclusion Criteria:
- Ventral Hernia requiring surgical repair
Exclusion Criteria:
- Pregnant women
Sites / Locations
- Carolinas Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Prospective
Retrospective
Arm Description
Participants enrolled to ventral hernia repair with Fortiva mesh
Retrospective participants with ventral hernia repair using Strattice mesh
Outcomes
Primary Outcome Measures
Frequency of participants with a Hernia recurrence
Frequency of participants with a hernia recurrence
Percent of participants with a Hernia recurrence
Percent of participants with a hernia recurrence
Secondary Outcome Measures
Frequency of participants with a Mesh related complication
Frequency of participants with a mesh related complication
Percent of participants with a Mesh related complication
Percent of participants with a mesh related complication
Full Information
NCT ID
NCT05572021
First Posted
October 6, 2022
Last Updated
October 3, 2023
Sponsor
Wake Forest University Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT05572021
Brief Title
A Comparison of the Outcomes in Fortiva and Strattice Mesh
Official Title
A Comparison of the Outcomes in Fortiva and Strattice Mesh
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 25, 2023 (Actual)
Primary Completion Date
February 2025 (Anticipated)
Study Completion Date
February 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A comparison of ventral hernia repair with Strattice and Fortiva mesh.Primary The study team aims to determine the hernia recurrence rates for RTI Surgical biologic mesh (Fortiva) compared to Strattice. Also the study team aims to determine the mesh related complications for RTI Surgical biologic mesh (Fortiva) compared to Strattice
Detailed Description
This study will be a prospective, matched study of patients using Fortiva biologic mesh to determine the rates of hernia recurrence and mesh related complication compared to Strattice mesh. Patients who meet the inclusion and exclusion criteria will be prospectively enrolled to receive a Ventral Hernia Repair (VHR) using Fortiva biologic mesh and will be compared to a retrospective cohort of patients with a VHR that utilized Strattice mesh. Patients will be propensity matched in a 1:3 (Fortiva : Strattice) fashion based on age, sex, and hernia defect size.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventral Hernia
Keywords
ventral hernia, surgical biologic mesh, hernia complications
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Comparison of prospective group to retrospective group
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Prospective
Arm Type
Experimental
Arm Description
Participants enrolled to ventral hernia repair with Fortiva mesh
Arm Title
Retrospective
Arm Type
Active Comparator
Arm Description
Retrospective participants with ventral hernia repair using Strattice mesh
Intervention Type
Device
Intervention Name(s)
Propspective VHR with Fortiva
Intervention Description
Ventral hernia repair using Fortiva biologic mesh
Intervention Type
Device
Intervention Name(s)
RetroSpective VHR with Strattice
Intervention Description
Retrospective cohort of ventral hernia repair patients using Strattice mesh
Primary Outcome Measure Information:
Title
Frequency of participants with a Hernia recurrence
Description
Frequency of participants with a hernia recurrence
Time Frame
1 year follow up post surgical repair
Title
Percent of participants with a Hernia recurrence
Description
Percent of participants with a hernia recurrence
Time Frame
1 year follow up post surgical repair
Secondary Outcome Measure Information:
Title
Frequency of participants with a Mesh related complication
Description
Frequency of participants with a mesh related complication
Time Frame
1 year follow up post surgical repair
Title
Percent of participants with a Mesh related complication
Description
Percent of participants with a mesh related complication
Time Frame
1 year follow up post surgical repair
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Ventral Hernia requiring surgical repair
Exclusion Criteria:
Pregnant women
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gregory T Scarola, MS
Phone
704-355-5379
Email
Gregory.Scarola@Atriumhealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Todd Heniford, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brant T Heniford, MD
Email
Todd.Heniford@AtriumHealth.org
First Name & Middle Initial & Last Name & Degree
Gregory T Scarola, MS
Email
Gregory.scarola@atriumhealth.org
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Comparison of the Outcomes in Fortiva and Strattice Mesh
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