Trial Outcomes & Findings for A Comparison of the Outcomes in Fortiva and Strattice Mesh (NCT NCT05572021)
NCT ID: NCT05572021
Last Updated: 2025-10-28
Results Overview
Frequency of participants with a hernia recurrence
TERMINATED
NA
6 participants
1 year follow up post surgical repair
2025-10-28
Participant Flow
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.
Participant milestones
| Measure |
Prospective
Participants enrolled to ventral hernia repair with Fortiva mesh
Prospective ventral hernia repair with Fortiva: Ventral hernia repair using Fortiva biologic mesh
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
0
|
|
Overall Study
COMPLETED
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
5
|
0
|
Reasons for withdrawal
| Measure |
Prospective
Participants enrolled to ventral hernia repair with Fortiva mesh
Prospective ventral hernia repair with Fortiva: Ventral hernia repair using Fortiva biologic mesh
|
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
|
|---|---|---|
|
Overall Study
Study terminated - PI left the institution and no other surgeons were interested in continuing study
|
5
|
0
|
Baseline Characteristics
A Comparison of the Outcomes in Fortiva and Strattice Mesh
Baseline characteristics by cohort
| Measure |
Prospective
n=6 Participants
Participants enrolled to ventral hernia repair with Fortiva mesh
Prospective ventral hernia repair with Fortiva: Ventral hernia repair using Fortiva biologic mesh
|
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
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
—
|
6 Participants
n=5 Participants
|
|
Age, Continuous
|
66.0 years
STANDARD_DEVIATION 6.8 • n=5 Participants
|
—
|
66.0 years
STANDARD_DEVIATION 6.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
—
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
—
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
—
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 year follow up post surgical repairPopulation: 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.
Frequency of participants with a hernia recurrence
Outcome measures
| Measure |
Prospective
n=1 Participants
Participants enrolled to ventral hernia repair with Fortiva mesh
Prospective ventral hernia repair with Fortiva: Ventral hernia repair using Fortiva biologic mesh
|
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
|
|---|---|---|
|
Frequency of Participants With a Hernia Recurrence
|
0 occurrence
|
—
|
PRIMARY outcome
Timeframe: 1 year follow up post surgical repairPopulation: 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.
Percentage of participants with a hernia recurrence
Outcome measures
| Measure |
Prospective
n=1 Participants
Participants enrolled to ventral hernia repair with Fortiva mesh
Prospective ventral hernia repair with Fortiva: Ventral hernia repair using Fortiva biologic mesh
|
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
|
|---|---|---|
|
Percentage of Participants With a Hernia Recurrence
|
0 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: 1 year follow up post surgical repairPopulation: 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.
Number of participants with a mesh related complication
Outcome measures
| Measure |
Prospective
n=1 Participants
Participants enrolled to ventral hernia repair with Fortiva mesh
Prospective ventral hernia repair with Fortiva: Ventral hernia repair using Fortiva biologic mesh
|
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
|
|---|---|---|
|
Number of Participants With a Mesh Related Complication
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: 1 year follow up post surgical repairPopulation: 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.
Percent of participants with a mesh related complication
Outcome measures
| Measure |
Prospective
n=1 Participants
Participants enrolled to ventral hernia repair with Fortiva mesh
Prospective ventral hernia repair with Fortiva: Ventral hernia repair using Fortiva biologic mesh
|
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
|
|---|---|---|
|
Percent of Participants With a Mesh Related Complication
|
0 percentage of participants
|
—
|
Adverse Events
Prospective
Retrospective
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place