NCT05572021

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 6, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 7, 2022

Completed
12 months until next milestone

Study Start

First participant enrolled

September 25, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 21, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 21, 2025

Completed
7 months until next milestone

Results Posted

Study results publicly available

October 28, 2025

Completed
Last Updated

October 28, 2025

Status Verified

September 1, 2024

Enrollment Period

1.5 years

First QC Date

October 6, 2022

Results QC Date

September 24, 2025

Last Update Submit

October 13, 2025

Conditions

Ventral Hernia

Keywords

ventral herniasurgical biologic meshhernia complications

Outcome Measures

Primary Outcomes (2)

  • Frequency of Participants With a Hernia Recurrence

    Frequency of participants with a hernia recurrence

    1 year follow up post surgical repair

  • Percentage of Participants With a Hernia Recurrence

    Percentage of participants with a hernia recurrence

    1 year follow up post surgical repair

Secondary Outcomes (2)

  • Number of Participants With a Mesh Related Complication

    1 year follow up post surgical repair

  • Percent of Participants With a Mesh Related Complication

    1 year follow up post surgical repair

Study Arms (2)

Prospective

EXPERIMENTAL

Participants enrolled to ventral hernia repair with Fortiva mesh

Device: Prospective Ventral Hernia Repair with Fortiva

Retrospective

ACTIVE COMPARATOR

Retrospective participants with ventral hernia repair using Strattice mesh

Device: RetroSpective Ventral Hernia Repair with Strattice

Interventions

Prospective Ventral Hernia Repair with FortivaDEVICE

Ventral hernia repair using Fortiva biologic mesh

Prospective
RetroSpective Ventral Hernia Repair with StratticeDEVICE

Retrospective cohort of ventral hernia repair patients using Strattice mesh

Retrospective

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ventral Hernia requiring surgical repair

You may not qualify if:

  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Carolinas Medical Center

Charlotte, North Carolina, 28204, United States

Location

MeSH Terms

Conditions

Hernia, Ventral

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Greg Scarola, MS, MBA
Organization
Atrium Health
Gregory.Scarola@advocatehealth.org
704-355-5766

Study Officials

  • Todd Heniford, MD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Comparison of prospective group to retrospective group
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2022

First Posted

October 7, 2022

Study Start

September 25, 2023

Primary Completion

March 21, 2025

Study Completion

March 21, 2025

Last Updated

October 28, 2025

Results First Posted

October 28, 2025

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)