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Tissue Matrix

Fortiva vs. Strattice for Ventral Hernia Repair

N/A

Waitlist Available

Led By Grant Bochicchio, MD

Research Sponsored by RTI Surgical

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months, 6 months, 12, and 24 months

Awards & highlights

Study Summary

This trial will compare the effectiveness of two different types of reinforcement for complex ventral hernia repair, and assess post-operative complication and long-term hernia recurrence rates.

Who is the study for?

This trial is for adults with a BMI of 40 or less who have large ventral hernias (200 cm2 or more). They must expect to live longer than a year, be able to consent, and commit to follow-up visits over two years. Exclusions include those under 18, very high-risk surgery candidates, extremely obese individuals, people with certain medical conditions affecting healing or active cancers, uncontrolled diabetes, recent tobacco users, pregnant/breastfeeding women.Check my eligibility

What is being tested?

The study compares Fortiva Porcine Dermis and Strattice Reconstructive Tissue Matrix in reinforcing complex ventral hernia repairs. It aims to assess which material leads to fewer complications and lower long-term recurrence rates of the hernia after surgery.See study design

What are the potential side effects?

While not explicitly listed here, potential side effects may include infection at the surgical site, allergic reactions to materials used in repair matrices like Fortiva or Strattice, pain at the implantation area, inflammation around the mesh area leading possibly to chronic discomfort.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months, 6 months, 12, and 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months, 6 months, 12, and 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months, 6 months, 12, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

The proportion of patients who experience a true hernia recurrence

Secondary outcome measures

Pain measured using the Visual Analog Scale for Pain

Patient satisfaction (using the SF-36 questionnaire)

Type of Adverse Events (volunteered and elicited)

Trial Design

2Treatment groups

Active Control

Group I: Fortiva™ Porcine DermisActive Control1 Intervention

Fortiva Porcine Dermis implantation during repair of complex ventral hernia

Group II: Strattice™ Reconstructive Tissue MatrixActive Control1 Intervention

Strattice tissue matrix implanted during repair of complex ventral hernia

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

RTI SurgicalLead Sponsor

16 Previous Clinical Trials

5,888 Total Patients Enrolled

Grant Bochicchio, MDPrincipal InvestigatorWashington University School of Medicine

Media Library

Fortiva Porcine Dermis (Tissue Matrix) Clinical Trial Eligibility Overview. Trial Name: NCT02587403 — N/A

Ventral Hernia Research Study Groups: Fortiva™ Porcine Dermis, Strattice™ Reconstructive Tissue Matrix

Ventral Hernia Clinical Trial 2023: Fortiva Porcine Dermis Highlights & Side Effects. Trial Name: NCT02587403 — N/A

Fortiva Porcine Dermis (Tissue Matrix) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02587403 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any enrollment opportunities at this moment for the clinical trial?

"As evidenced on clinicaltrials.gov, this experiment is no longer actively enrolling patients - the initial posting being December 2nd 2015 and last update March 24th 2022. However, there are other 160 studies recruiting participants at present time."

Answered by AI

Are senior citizens among the eligible participants for this clinical investigation?

"This trial seeks participants who are of legal age or elder, with the upper limit being 85 years."

Answered by AI

Am I eligible to partake in this research program?

"This clinical research is enrolling 120 individuals with ventral hernias, ranging from 18 years old to 85. To be considered for the study, participants must have a BMI of 40 or lower and their hernia defect should exceed 200 cm2 in area; alternatively multiple smaller defects can combine to equal an estimated 200 cm2. If intra-operatively it appears that this criteria isn't met then those patients will be removed from the trial. Furthermore, all eligible volunteers need to commit to attending follow up appointments for two years after surgery has been performed."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Comparison of Fortiva and Strattice Tissue Matrices in Complex, Ventral Hernia Repair

2015. "A Comparison of Fortiva and Strattice Tissue Matrices in Complex, Ventral Hernia Repair". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02587403.