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Completed

NCT Number: NCT04853550

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

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

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Key information

Conditions

Ventral Hernia Hernia Hernia, Abdominal Hernia, Ventral Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Louisville

Louisville, Kentucky, 40202, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Hernia repair with Strattice Mesh
  • Age 18 or older

Exclusion criteria

  • Under age 18
  • No history of hernia repair

Treatment and study plan

Strattice Mesh

Device

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.

Primary outcomes

  1. Hernia recurrence

    Time frame: 24 Months

    Percentage of patients with recurrence at long-term (>12 months) follow-up.

Secondary outcomes

  1. Quality of LIfe Questionnaire

    Time frame: 24 Months

    Percentage of patients with mean quality of life scores at long-term (>12 months) follow-up.

Sponsors and collaborators

Lead sponsor

University of Louisville

Other

Collaborators

  • AllerGen NCE Inc.

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Apr 21, 2021
Registry last updated
Jul 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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