Ventral Hernia
Conditions
Keywords
ventral hernia, surgical biologic mesh, hernia complications
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.
Interventions
DEVICEProspective Ventral Hernia Repair with Fortiva
Ventral hernia repair using Fortiva biologic mesh
DEVICERetroSpective Ventral Hernia Repair with Strattice
Retrospective cohort of ventral hernia repair patients using Strattice mesh
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Comparison of prospective group to retrospective group
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Ventral Hernia requiring surgical repair
Exclusion criteria
* Pregnant women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Participants With a Hernia Recurrence | 1 year follow up post surgical repair | Frequency of participants with a hernia recurrence |
| Percentage of Participants With a Hernia Recurrence | 1 year follow up post surgical repair | Percentage of participants with a hernia recurrence |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a Mesh Related Complication | 1 year follow up post surgical repair | Number of participants with a mesh related complication |
| Percent of Participants With a Mesh Related Complication | 1 year follow up post surgical repair | Percent of participants with a mesh related complication |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Prospective Participants enrolled to ventral hernia repair with Fortiva mesh
Prospective ventral hernia repair with Fortiva: Ventral hernia repair using Fortiva biologic mesh | 6 |
| 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 |
| Total | 6 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Study terminated - PI left the institution and no other surgeons were interested in continuing study | 5 | 0 |
Baseline characteristics
| Characteristic | Total | Prospective |
|---|---|---|
| Age, Continuous | 66.0 years STANDARD_DEVIATION 6.8 | 66.0 years STANDARD_DEVIATION 6.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 6 Participants | 6 Participants |
| Sex: Female, Male Female | 4 Participants | 4 Participants |
| Sex: Female, Male Male | 2 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 0 |
| other Total, other adverse events | 0 / 6 | 0 / 0 |
| serious Total, serious adverse events | 0 / 6 | 0 / 0 |
Outcome results
Primary
Frequency of Participants With a Hernia Recurrence
Frequency of participants with a hernia recurrence
Time frame: 1 year follow up post surgical repair
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prospective | Frequency of Participants With a Hernia Recurrence | 0 occurrence |
Primary
Percentage of Participants With a Hernia Recurrence
Percentage of participants with a hernia recurrence
Time frame: 1 year follow up post surgical repair
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prospective | Percentage of Participants With a Hernia Recurrence | 0 percentage of participants |
Secondary
Number of Participants With a Mesh Related Complication
Number of participants with a mesh related complication
Time frame: 1 year follow up post surgical repair
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prospective | Number of Participants With a Mesh Related Complication | 0 Participants |
Secondary
Percent of Participants With a Mesh Related Complication
Percent of participants with a mesh related complication
Time frame: 1 year follow up post surgical repair
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prospective | Percent of Participants With a Mesh Related Complication | 0 percentage of participants |