Ventral HerniaNCT02587403
A Comparison of Fortiva and Strattice Tissue Matrices in Complex, Ventral Hernia Repair
A study testing Fortiva™ Porcine Dermis and Strattice™ Reconstructive Tissue Matrix in people with Ventral Hernia, run by RTI Surgical at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Ventral Hernia
- What is being tested?
- Fortiva™ Porcine Dermis and Strattice™ Reconstructive Tissue Matrix
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Dec 2015to 19 Sep 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 Patients whose defects do NOT meet or exceed 200 cm2 intra-operatively will be withdrawn from the study and will be considered an intra-operative screen failure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)
Who cannot join
- < 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
Show all 23Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Prospective Study Comparing Fortiva™ Porcine Dermis vs. Strattice™ Reconstructive Tissue Matrix in Patients Undergoing Complex Open Primary Ventral Hernia Repair
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.
Read the 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.
- Conditions
- Ventral Hernia
- Being tested
- Fortiva™ Porcine Dermis, Strattice™ Reconstructive Tissue Matrix
- Medical subject headings
- Hernia, Ventral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fortiva™ Porcine DermisDevice
Fortiva Porcine Dermis implantation during repair of complex ventral hernia
Strattice™ Reconstructive Tissue MatrixDevice
Strattice tissue matrix implanted during repair of complex ventral hernia
| Study group | Role | What they receive |
|---|---|---|
| Fortiva™ Porcine Dermis | Active comparator | Fortiva Porcine Dermis implantation during repair of complex ventral hernia Receives: Device: Fortiva™ Porcine Dermis |
| Strattice™ Reconstructive Tissue Matrix | Active comparator | Strattice tissue matrix implanted during repair of complex ventral hernia Receives: Device: Strattice™ Reconstructive Tissue Matrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Proportion of Patients Who Experience a True Hernia Recurrence
True hernia recurrence as diagnosed by physical exam or CT scan
Measured: 12 months
Secondary outcomes (4)
SF-36 MCS
SF-36 mental component summary scale ranges from 0-100. Higher score indicates better self reported health.
Measured: 3 months
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
Measured: 3 months
True Recurrence at 24 Months
Measured: 24 months
Time to Discharge
Time is from date of procedure to date of each patient discharge. Mean of each group is provided
Measured: Discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2015 (estimated)
- Study start2 Dec 2015
- Primary completion19 Sep 2023
- Study completion19 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ventral HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- RTI Surgical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Grant Bochicchio, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02587403
- Sponsor's protocol ID
- RTI-2015-02
- Status last verified
- Dec 2024
- First submitted
- 22 Oct 2015
- Last updated
- 27 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Prospective Study Comparing Fortiva™ Porcine Dermis vs. Strattice™ Reconstructive Tissue Matrix in Patients Undergoing Complex Open Primary Ventral Hernia Repair
- ClinicalTrials.gov ID
- NCT02587403
- Acronym / sponsor ID
- RTI-2015-02
- Conditions
- Ventral Hernia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- RTI SurgicalIndustry (pharma, biotech, devices)
- Study start
- 2 Dec 2015 (actual)
- Primary completion
- 19 Sep 2023 (actual)
- Study completion
- 19 Sep 2023 (actual)
- First posted
- 27 Oct 2015 (estimated)
- Results
- Posted 27 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fortiva™ Porcine Dermis | Active comparator | Device: Fortiva™ Porcine DermisFortiva Porcine Dermis implantation during repair of complex ventral hernia |
| Strattice™ Reconstructive Tissue Matrix | Active comparator | Device: Strattice™ Reconstructive Tissue MatrixStrattice tissue matrix implanted during repair of complex ventral hernia |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (23 listed)
- < 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fortiva™ Porcine DermisFortiva Porcine Dermis implantation during repair of complex ventral hernia | Device | Fortiva™ Porcine Dermis |
| Strattice™ Reconstructive Tissue MatrixStrattice tissue matrix implanted during repair of complex ventral hernia | Device | Strattice™ Reconstructive Tissue Matrix |
Primary outcome
The Proportion of Patients Who Experience a True Hernia Recurrence
Time frame: 12 months
True hernia recurrence as diagnosed by physical exam or CT scan
4 secondary outcomes
SF-36 MCS
Time frame: 3 months
Pain Measured Using the Visual Analog Scale for Pain
Time frame: 3 months
True Recurrence at 24 Months
Time frame: 24 months
Time to Discharge
Time frame: Discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Ventral Hernia
Recruiting
Duramesh Versus Minimally Invasive IPOM for High-Risk Umbilical Hernia Repairs
Umbilical Hernia, Ventral Hernia
Active, not recruitingObservational study
Assessment of GORE® SYNECOR Biomaterial in Focused Patient Populations and Long-Term Application
Hernia, Ventral, Hernia Incisional
Recruiting
GORE® ENFORM Biomaterial Product Study
Hernia, Ventral, Hernia, Hiatal
RecruitingPhase 4
Preoperative BOTOX® Injection for Large Ventral Hernia Repair
Hernia Abdominal Wall, Botox Injection
Not yet recruiting
SUTURE TYPE AND RECURRENCE RISK AFTER INCISIONAL HERNIA REPAIR
Ventral Incisional Hernia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Grant Bochicchio, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fortiva™ Porcine Dermis and Strattice™ Reconstructive Tissue Matrix in people with Ventral Hernia, run by RTI Surgical at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Proportion of Patients Who Experience a True Hernia Recurrence (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.