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PI left the institution
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prospective | Experimental | Participants enrolled to ventral hernia repair with Fortiva mesh |
|
| Retrospective | Active Comparator | Retrospective participants with ventral hernia repair using Strattice mesh |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prospective Ventral Hernia Repair with Fortiva | Device | Ventral hernia repair using Fortiva biologic mesh |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Participants With a Hernia Recurrence | Frequency of participants with a hernia recurrence | 1 year follow up post surgical repair |
| Percentage of Participants With a Hernia Recurrence | Percentage of participants with a hernia recurrence | 1 year follow up post surgical repair |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Mesh Related Complication | Number of participants with a mesh related complication | 1 year follow up post surgical repair |
| Percent of Participants With a Mesh Related Complication |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Todd Heniford, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carolinas Medical Center | Charlotte | North Carolina | 28204 | United States |
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This study planned to use matched analysis matching the prospective and retrospective arms. For studies of this fashion all prospective participants are enrolled first to sample size and then matching retrospective patients are enrolled. It is not a standard practice to match patients as they enroll. This study was terminated before prospective arm enrollment was completed. Therefore, no participants were enrolled in the retrospective arm.
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| ID | Title | Description |
|---|---|---|
| FG000 | Prospective | Participants enrolled to ventral hernia repair with Fortiva mesh Prospective ventral hernia repair with Fortiva: Ventral hernia repair using Fortiva biologic mesh |
| FG001 | Retrospective | Retrospective participants with ventral hernia repair using Strattice mesh RetroSpective ventral hernia repair with Strattice: Retrospective cohort of ventral hernia repair patients using Strattice mesh |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
This study planned to use matched analysis matching the prospective and retrospective arms. For studies of this fashion all prospective participants are enrolled first to sample size and then matching retrospective patients are enrolled. It is not a standard practice to match patients as they enroll. This study was terminated before prospective arm enrollment was completed. Therefore, no participants were enrolled in the retrospective arm.
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| ID | Title | Description |
|---|---|---|
| BG000 | Prospective | Participants enrolled to ventral hernia repair with Fortiva mesh Prospective ventral hernia repair with Fortiva: Ventral hernia repair using Fortiva biologic mesh |
| BG001 | Retrospective |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Frequency of Participants With a Hernia Recurrence | Frequency of participants with a hernia recurrence | This study planned to use matched analysis matching the prospective and retrospective arms. For studies of this fashion all prospective participants are enrolled first to sample size and then matching retrospective patients are enrolled. It is not a standard practice to match patients as they enroll. This study was terminated before prospective arm enrollment was completed. Therefore, no participants were enrolled in the retrospective arm. | Posted | Number | occurrence | 1 year follow up post surgical repair |
|
Baseline through 6 months. After 6-months events were not attributed to surgical procedure.
This study planned to use matched analysis matching the prospective and retrospective arms. For studies of this fashion all prospective participants are enrolled first to sample size and then matching retrospective patients are enrolled. It is not a standard practice to match patients as they enroll. This study was terminated before prospective arm enrollment was completed. Therefore, no participants were enrolled in the retrospective arm.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Prospective | Participants enrolled to ventral hernia repair with Fortiva mesh Prospective ventral hernia repair with Fortiva: Ventral hernia repair using Fortiva biologic mesh |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Greg Scarola, MS, MBA | Atrium Health | 704-355-5766 | Gregory.Scarola@advocatehealth.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 28, 2025 | Sep 24, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 12, 2025 | Aug 27, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D006555 | Hernia, Ventral |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Comparison of prospective group to retrospective group
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| RetroSpective Ventral Hernia Repair with Strattice | Device | Retrospective cohort of ventral hernia repair patients using Strattice mesh |
|
Percent of participants with a mesh related complication
| 1 year follow up post surgical repair |
Retrospective participants with ventral hernia repair using Strattice mesh
RetroSpective ventral hernia repair with Strattice: Retrospective cohort of ventral hernia repair patients using Strattice mesh
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 |
| Retrospective |
Retrospective participants with ventral hernia repair using Strattice mesh RetroSpective ventral hernia repair with Strattice: Retrospective cohort of ventral hernia repair patients using Strattice mesh |
|
|
| Primary | Percentage of Participants With a Hernia Recurrence | Percentage of participants with a hernia recurrence | This study planned to use matched analysis matching the prospective and retrospective arms. For studies of this fashion all prospective participants are enrolled first to sample size and then matching retrospective patients are enrolled. It is not a standard practice to match patients as they enroll. This study was terminated before prospective arm enrollment was completed. Therefore, no participants were enrolled in the retrospective arm. | Posted | Number | percentage of participants | 1 year follow up post surgical repair |
|
|
|
| Secondary | Number of Participants With a Mesh Related Complication | Number of participants with a mesh related complication | This study planned to use matched analysis matching the prospective and retrospective arms. For studies of this fashion all prospective participants are enrolled first to sample size and then matching retrospective patients are enrolled. It is not a standard practice to match patients as they enroll. This study was terminated before prospective arm enrollment was completed. Therefore, no participants were enrolled in the retrospective arm. | Posted | Count of Participants | Participants | 1 year follow up post surgical repair |
|
|
|
| Secondary | Percent of Participants With a Mesh Related Complication | Percent of participants with a mesh related complication | This study planned to use matched analysis matching the prospective and retrospective arms. For studies of this fashion all prospective participants are enrolled first to sample size and then matching retrospective patients are enrolled. It is not a standard practice to match patients as they enroll. This study was terminated before prospective arm enrollment was completed. Therefore, no participants were enrolled in the retrospective arm. | Posted | Number | percentage of participants | 1 year follow up post surgical repair |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Retrospective | Retrospective participants with ventral hernia repair using Strattice mesh RetroSpective ventral hernia repair with Strattice: Retrospective cohort of ventral hernia repair patients using Strattice mesh | 0 | 0 | 0 | 0 | 0 | 0 |
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