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

June 28, 2023 updated by: Farid Kehdy, University of Louisville

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

63

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Subjects who have undergone ventral hernia repair with Strattice Mesh between January 1, 2013 and November 1, 2019

Description

Inclusion Criteria:

  • Hernia repair with Strattice Mesh
  • Age 18 or older

Exclusion Criteria:

  • Under age 18
  • No history of hernia repair

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hernia recurrence
Time Frame: 24 Months
Percentage of patients with recurrence at long-term (>12 months) follow-up.
24 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of LIfe Questionnaire
Time Frame: 24 Months
Percentage of patients with mean quality of life scores at long-term (>12 months) follow-up.
24 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Louisville

Collaborators

AllerGen NCE Inc.

Investigators

  • Principal Investigator: Farid Kehdy, MD, University of Louisville

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 13, 2019

Primary Completion (Actual)

November 14, 2022

Study Completion (Actual)

November 14, 2022

Study Registration Dates

First Submitted

April 16, 2021

First Submitted That Met QC Criteria

April 16, 2021

First Posted (Actual)

April 21, 2021

Study Record Updates

Last Update Posted (Actual)

July 3, 2023

Last Update Submitted That Met QC Criteria

June 28, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19.0980

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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