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Long-Term Follow-up After Ventral Hernia Repair With Strattice Mesh

Long Term Follow-up After Ventral Hernia Repair With Strattice Mesh

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04853550
Enrollment
63
Registered
2021-04-21
Start date
2019-11-13
Completion date
2022-11-14
Last updated
2023-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventral Hernia

Brief summary

This study will assess long-term outcomes (greater than 12 months) following ventral hernia repair with Strattice mesh reinforcement.

Detailed description

Subjects will be retrospectively identified as having undergone operative repair of ventral hernia with Strattice mesh reinforcement during the period January 1, 2013 - November 1, 2017. Follow-up data will be collected either at a postoperative clinic visit or via telephone interview.

Interventions

DEVICEStrattice Mesh

Subjects will be restrospectively identified has having undergone ventral hernia repair with Strattice mesh reinforcement. Once identified long term follow-up data will be collected.

Sponsors

AllerGen NCE Inc.
CollaboratorINDUSTRY
University of Louisville
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

* Hernia repair with Strattice Mesh * Age 18 or older

Exclusion criteria

* Under age 18 * No history of hernia repair

Design outcomes

Primary

MeasureTime frameDescription
Hernia recurrence24 MonthsPercentage of patients with recurrence at long-term (\>12 months) follow-up.

Secondary

MeasureTime frameDescription
Quality of LIfe Questionnaire24 MonthsPercentage of patients with mean quality of life scores at long-term (\>12 months) follow-up.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026