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Biologic Mesh

Fortiva vs Strattice Mesh for Hernia Repair

N/A

Recruiting

Led By Todd Heniford, MD

Research Sponsored by Wake Forest University Health Sciences

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 1 year follow up post surgical repair

Awards & highlights

Study Summary

This trial is comparing the recurrence rates and complications of two different types of hernia repair mesh.

Who is the study for?

This trial is for individuals who need surgery to repair a ventral hernia, which is a bulge of tissues through an opening within abdominal muscles. Pregnant women are not eligible to participate.Check my eligibility

What is being tested?

The study compares two types of mesh used in hernia repair surgeries: Fortiva and Strattice. It looks at how often the hernia comes back after using each mesh and what complications might arise with each type.See study design

What are the potential side effects?

While specific side effects aren't listed, common ones from hernia mesh may include pain, infection, hernia recurrence, adhesion (tissue sticking together), and possible allergic reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year follow up post surgical repair

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year follow up post surgical repair

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year follow up post surgical repair for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Frequency of participants with a Hernia recurrence

Percent of participants with a Hernia recurrence

Secondary outcome measures

Frequency of participants with a Mesh related complication

Percent of participants with a Mesh related complication

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: ProspectiveExperimental Treatment1 Intervention

Participants enrolled to ventral hernia repair with Fortiva mesh

Group II: RetrospectiveActive Control1 Intervention

Retrospective participants with ventral hernia repair using Strattice mesh

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor

1,243 Previous Clinical Trials

1,004,530 Total Patients Enrolled

Todd Heniford, MDPrincipal InvestigatorWake Forest University Health Sciences

5 Previous Clinical Trials

908 Total Patients Enrolled

Media Library

Fortiva (Biologic Mesh) Clinical Trial Eligibility Overview. Trial Name: NCT05572021 — N/A

Ventral Hernia Research Study Groups: Prospective, Retrospective

Ventral Hernia Clinical Trial 2023: Fortiva Highlights & Side Effects. Trial Name: NCT05572021 — N/A

Fortiva (Biologic Mesh) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05572021 — N/A

Frequently Asked Questions

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

Could I potentially partake in this research endeavor?

"This study is inviting 200 individuals of ages 18 to 100 with confirmed ventral hernias for surgery. Qualified applicants must have a recognised need for surgical repair due to their affliction."

Answered by AI

What are the objectives of this experiment?

"The main goal of this surgical trial, which will be measured over the course of a year post-repair, is to assess hernia recurrence rate. Additionally, researchers are evaluating mesh-associated complications frequency and prevalence."

Answered by AI

Are octogenarians eligible for this research experiment?

"This clinical trial is seeking patients aged between 18 and 100, with 16 studies for younger individuals and 134 for those beyond 65 years old."

Answered by AI

Are there any openings for participation in this trial at present?

"Reports hosted on clinicaltrials.gov suggest that this medical trial is not presently seeking patients; the study was initially posted January 1st 2023 and last updated October 7th 2022. Although it is inactive, there are 160 other trials actively recruiting participants currently."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Comparison of the Outcomes in Fortiva and Strattice Mesh

2023. "A Comparison of the Outcomes in Fortiva and Strattice Mesh". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05572021.

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