Ventral Hernia
Conditions
Brief summary
The objective of this study is to compare the effectiveness of Fortiva Porcine Dermis versus Strattice Reconstructive Tissue Matrix for the underlay reinforcement of complex ventral hernia repair and assess post-operative complication rates, long term hernia recurrence rates.
Detailed description
This is a randomized, prospective, double-blinded study evaluating the efficacy of Fortiva Porcine Dermis versus Strattice Reconstructive Tissue Matrix in 120 patients with large complex abdominal wall ventral hernias undergoing single stage repair. The patient will be blinded to treatment as well as an independent qualified evaluator to confirm evidence of reoccurrence. This post-market study compares two FDA cleared biologic hernia materials. Fortiva™ porcine dermis, processed by RTI Surgical, Inc., a non-cross linked porcine dermis will be compared to Strattice™ Reconstructive Tissue Matrix by Life Cell, a non-cross linked porcine dermis for reinforcement during the single stage open reconstruction of abdominal wall defects. The primary outcome will be hernia recurrence at 1 year. Outcomes will be evaluated at 6 weeks, 3 months, 6 months and 12 months and 24 months.
Interventions
DEVICEFortiva™ Porcine Dermis
Fortiva Porcine Dermis implantation during repair of complex ventral hernia
Strattice tissue matrix implanted during repair of complex ventral hernia
Sponsors
RTI Surgical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* 18 years of age or greater * Have a BMI \< or equal to 40 * Have a pre-operative estimated hernia defect of 200 cm2 OR multiple hernia defects whose combined area is ≥ an estimated 200 cm2. Patients whose defects do NOT meet or exceed 200 cm2 intra-operatively will be withdrawn from the study and will be considered an intra-operative screen failure * Have no contraindications to the test material (s) * Have a life expectancy greater than 1 year in the opinion of the Investigator * Able to provide informed consent * Able and willing to return for scheduled study visits over 2 years post-operatively (following research related surgery)
Exclusion criteria
* \< 18 years of age * Subject is determined to have an American Society of Anesthesiologists'(ASA) physical class of 4, 5, or 6 * Have a BMI \>40 * Have a hernia estimated to be \<200 cm2 * Have abdominal loss of domain such that the operation would be impractical or would adversely affect respiratory or cardiovascular function to an unacceptable degree in the opinion of the investigator * Inability to close the fascia primarily without abdominal wall mobilization or component separation * Participation in an investigational drug or device study that would impact the safety or scientific integrity of this study (in the opinion of the Investigator and with the approval of the Sponsor) within the past 6 weeks prior to enrollment into this trial * Have active necrotizing fasciitis or any other known active local or systemic infection * Have a known collagen metabolism disorder or any medical condition that could interfere with normal tissue healing process as determined by the Investigator * Have a known active malignancy present and/or had chemotherapy 12 weeks prior to screening or planned chemotherapy within 12 weeks of enrollment with exception of BCC or SCC * Have known moderate to severe cirrhosis which in the opinion of the Investigator would impact the outcome of this trial * Have a life expectancy less than 1 year * Be unable to participate in the informed consent process * Be unable or unwilling to return for scheduled study visits over the 2 year post-operative assessment period * Received high dose steroids (\>/=100mg of prednisone) within the past 6 weeks * Known tobacco use within the past 6 weeks or positive serum cotinine test at time of admission * Uncontrolled diabetes (i.e. known HbA1C value \> 7% within the last 6 weeks) * History of drug addiction (recreational drugs, prescription drugs or alcohol) that in the Investigator's opinion may interfere with protocol assessments and/or the subject's ability to complete the required follow up * Pregnancy and/or breastfeeding * Enterocutaneous fistula * Ventral hernia repairs involving active infection * Inability to obtain primary fascial closure (Intra-operatively) * Planned use of external VAC dressing intra-operatively
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Proportion of Patients Who Experience a True Hernia Recurrence | 12 months | True hernia recurrence as diagnosed by physical exam or CT scan |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SF-36 MCS | 3 months | SF-36 mental component summary scale ranges from 0-100. Higher score indicates better self reported health. |
| Pain Measured Using the Visual Analog Scale for Pain | 3 months | Visual analog scale measures extremes of pain on a scale from 0-10. 0 is no pain and 10 is worst pain |
| True Recurrence at 24 Months | 24 months | — |
| Time to Discharge | Discharge | Time is from date of procedure to date of each patient discharge. Mean of each group is provided |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fortiva™ Porcine Dermis Fortiva™ Porcine Dermis: Fortiva Porcine Dermis implantation during repair of complex ventral hernia | 60 |
| Strattice™ Reconstructive Tissue Matrix Strattice™ Reconstructive Tissue Matrix: Strattice tissue matrix implanted during repair of complex ventral hernia | 60 |
| Total | 120 |
Baseline characteristics
| Characteristic | Fortiva™ Porcine Dermis | Strattice™ Reconstructive Tissue Matrix | Total |
|---|---|---|---|
| Age, Continuous | 59.6 years STANDARD_DEVIATION 10.5 | 59.2 years STANDARD_DEVIATION 13.1 | 59.4 years STANDARD_DEVIATION 11.8 |
| Body Mass Index | 31.7 kg/m^2 STANDARD_DEVIATION 4.7 | 32.3 kg/m^2 STANDARD_DEVIATION 5.4 | 32 kg/m^2 STANDARD_DEVIATION 5.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants | 8 Participants | 18 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 50 Participants | 51 Participants | 101 Participants |
| Region of Enrollment United States | 60 participants | 60 participants | 120 participants |
| Sex: Female, Male Female | 35 Participants | 27 Participants | 62 Participants |
| Sex: Female, Male Male | 25 Participants | 33 Participants | 58 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 60 | 5 / 60 |
| other Total, other adverse events | 25 / 60 | 23 / 60 |
| serious Total, serious adverse events | 13 / 60 | 23 / 60 |
Outcome results
Primary
The Proportion of Patients Who Experience a True Hernia Recurrence
True hernia recurrence as diagnosed by physical exam or CT scan
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fortiva™ Porcine Dermis | The Proportion of Patients Who Experience a True Hernia Recurrence | 2 Participants |
| Strattice™ Reconstructive Tissue Matrix | The Proportion of Patients Who Experience a True Hernia Recurrence | 1 Participants |
Secondary
Pain Measured Using the Visual Analog Scale for Pain
Visual analog scale measures extremes of pain on a scale from 0-10. 0 is no pain and 10 is worst pain
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fortiva™ Porcine Dermis | Pain Measured Using the Visual Analog Scale for Pain | 2.41 units on a scale | Standard Deviation 2.22 |
| Strattice™ Reconstructive Tissue Matrix | Pain Measured Using the Visual Analog Scale for Pain | 2.37 units on a scale | Standard Deviation 2.32 |
Secondary
SF-36 MCS
SF-36 mental component summary scale ranges from 0-100. Higher score indicates better self reported health.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fortiva™ Porcine Dermis | SF-36 MCS | 48.9 score on a scale | Standard Deviation 9.2 |
| Strattice™ Reconstructive Tissue Matrix | SF-36 MCS | 48.9 score on a scale | Standard Deviation 9.2 |
Secondary
Time to Discharge
Time is from date of procedure to date of each patient discharge. Mean of each group is provided
Time frame: Discharge
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fortiva™ Porcine Dermis | Time to Discharge | 7.93 Days | Standard Deviation 2.32 |
| Strattice™ Reconstructive Tissue Matrix | Time to Discharge | 8.11 Days | Standard Deviation 3.39 |
Secondary
True Recurrence at 24 Months
Time frame: 24 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fortiva™ Porcine Dermis | True Recurrence at 24 Months | 3 Participants |
| Strattice™ Reconstructive Tissue Matrix | True Recurrence at 24 Months | 1 Participants |