Ventral HerniaNCT05572021

A Comparison of the Outcomes in Fortiva and Strattice Mesh

A study testing Prospective Ventral Hernia Repair with Fortiva and RetroSpective Ventral Hernia Repair with Strattice in people with Ventral Hernia, run by Wake Forest University Health Sciences at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 to 100 years
Conditions the study is for: Ventral Hernia
What is being tested?: Prospective Ventral Hernia Repair with Fortiva and RetroSpective Ventral Hernia Repair with Strattice
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 6 participants
Where: 1 siteUnited States
Study dates: 25 Sep 2023to 21 Mar 2025
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 100 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Ventral Hernia requiring surgical repair

Who cannot join

Pregnant women

Trial locations and contacts

1 site in 1 country.

United States1 site

Carolinas Medical Center
Charlotte, North Carolina, 28204

Other trials in United States

About this study

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

Read the 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.

Conditions: Ventral Hernia
Being tested: Prospective Ventral Hernia Repair with Fortiva, RetroSpective Ventral Hernia Repair with Strattice
Keywords: ventral hernia, surgical biologic mesh, hernia complications
Medical subject headings: Hernia, Ventral

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Prospective Ventral Hernia Repair with FortivaDevice
Ventral hernia repair using Fortiva biologic mesh
RetroSpective Ventral Hernia Repair with StratticeDevice
Retrospective cohort of ventral hernia repair patients using Strattice mesh

Study groups in NCT05572021
Study group	Role	What they receive
Prospective	Experimental	Participants enrolled to ventral hernia repair with Fortiva mesh Receives: Device: Prospective Ventral Hernia Repair with Fortiva
Retrospective	Active comparator	Retrospective participants with ventral hernia repair using Strattice mesh Receives: Device: RetroSpective Ventral Hernia Repair with Strattice

What is being measured

The primary outcome is the main question the study is designed to answer.

Frequency of Participants With a Hernia Recurrence
Frequency of participants with a hernia recurrence
Measured: 1 year follow up post surgical repair
Percentage of Participants With a Hernia Recurrence
Percentage of participants with a hernia recurrence
Measured: 1 year follow up post surgical repair

Secondary outcomes (2)

Number of Participants With a Mesh Related Complication
Number of participants with a mesh related complication
Measured: 1 year follow up post surgical repair
Percent of Participants With a Mesh Related Complication
Percent of participants with a mesh related complication
Measured: 1 year follow up post surgical repair

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Sep 202321 Mar 2025

First posted7 Oct 2022
Study start25 Sep 2023
Primary completion21 Mar 2025
Study completion21 Mar 2025

Why it stopped: PI left the institution

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.
More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
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: Non-randomised
Intervention model: Single group
Model description: Comparison of prospective group to retrospective group
Masking: None (open label)
Enrolment: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05572021
Sponsor's protocol ID: IRB00088523
Status last verified: Sep 2024
First submitted: 6 Oct 2022
Last updated: 28 Oct 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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

All Ventral Hernia trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Comparison of the Outcomes in Fortiva and Strattice Mesh
ClinicalTrials.gov ID: NCT05572021
Acronym / sponsor ID: IRB00088523
Conditions: Ventral Hernia
Keywords: ventral hernia, surgical biologic mesh, hernia complications
Study type: Interventional
Recruitment status: TerminatedReason stopped: PI left the institution
Enrolment: 6 participants (actual)
Lead sponsor: Wake Forest University Health SciencesUniversity, hospital or other
Study start: 25 Sep 2023 (actual)
Primary completion: 21 Mar 2025 (actual)
Study completion: 21 Mar 2025 (actual)
First posted: 7 Oct 2022 (actual)
Results: Posted 28 Oct 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2
Model description: Comparison of prospective group to retrospective group

Arm	Type	Receives
Prospective	Experimental	Device: Prospective Ventral Hernia Repair with FortivaParticipants enrolled to ventral hernia repair with Fortiva mesh
Retrospective	Active comparator	Device: RetroSpective Ventral Hernia Repair with StratticeRetrospective participants with ventral hernia repair using Strattice mesh

Who may qualify

Ages: 18 to 100 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Ventral Hernia requiring surgical repair

Key exclusion criteria (1 listed)

Pregnant women

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
Prospective Ventral Hernia Repair with FortivaVentral hernia repair using Fortiva biologic mesh	Device	Prospective
RetroSpective Ventral Hernia Repair with StratticeRetrospective cohort of ventral hernia repair patients using Strattice mesh	Device	Retrospective

Primary outcome

Frequency of Participants With a Hernia Recurrence
Time frame: 1 year follow up post surgical repair
Frequency of participants with a hernia recurrence
Percentage of Participants With a Hernia Recurrence
Time frame: 1 year follow up post surgical repair
Percentage of participants with a hernia recurrence

2 secondary outcomes

Number of Participants With a Mesh Related Complication
Time frame: 1 year follow up post surgical repair
Percent of Participants With a Mesh Related Complication
Time frame: 1 year follow up post surgical repair

Results and safety

Results posted to the registry on 28 Oct 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Prospective	6	1
Retrospective	0	0

Primary outcome: Frequency of Participants With a Hernia Recurrence

Time frame: 1 year follow up post surgical repair. Number. Unit: occurrence

Measure	Prospective n = 1	Retrospective n = 0
Value	0	–

Population analysed: 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.

Primary outcome: Percentage of Participants With a Hernia Recurrence

Time frame: 1 year follow up post surgical repair. Number. Unit: percentage of participants

Measure	Prospective n = 1	Retrospective n = 0
Value	0	–

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline through 6 months. After 6-months events were not attributed to surgical procedure.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Prospective	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Retrospective	0 of 0	0 of 0	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2025.
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.

Todd Heniford, MD principal investigator

Wake Forest University Health Sciences

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 28 Oct 2025. 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 28 Oct 2025). 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?

Frequency of Participants With a Hernia Recurrence (time frame: 1 year follow up post surgical repair). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05572021.

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 28 Oct 2025.