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NCT04853550 Clinical Trial

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

Ventral Hernia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04853550
Other study ID # 19.0980
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 13, 2019
Est. completion date November 14, 2022

Study information
Verified date June 2023
Source University of Louisville
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 63
Est. completion date November 14, 2022
Est. primary completion date November 14, 2022
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Hernia repair with Strattice Mesh - Age 18 or older Exclusion Criteria: - Under age 18 - No history of hernia repair

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Strattice 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.

Locations
Country Name City State
United States University of Louisville Louisville Kentucky

Sponsors (2)
Lead Sponsor Collaborator
University of Louisville AllerGen NCE Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Hernia recurrence Percentage of patients with recurrence at long-term (>12 months) follow-up. 24 Months
Secondary Quality of LIfe Questionnaire Percentage of patients with mean quality of life scores at long-term (>12 months) follow-up. 24 Months
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