Status:
TERMINATED
Observational Biologic or Prosthetic Mesh
Lead Sponsor:
University of South Florida
Collaborating Sponsors:
Integra LifeSciences Corporation
Conditions:
Ventral Incisional Hernia
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to assess the incidence of hernia recurrence with the use of biologic and prosthetic mesh in ventral hernia repair.
Detailed Description
Incisional hernias are very common, leading to over 380,000 operative repairs done annually. Despite the commonality of this problem, there has been no single operative repair that has become the stan...
Eligibility Criteria
Inclusion
- Male and female patients \> 21 years old.
- Able to provide informed consent in English or Spanish.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
Exclusion
- Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study, if applicable.
- Allergy or hypersensitivity to materials in porcine-based study products, prosthetic or biological meshes, or personal preference.
- Male and female patients ≤ 21 years old
- History of drug addiction (recreational drugs, prescription drugs or alcohol) that in the Investigator's opinion may interfere with protocol assessments and/or the subject's ability to complete the required follow up.
- Serious or active medical or psychiatric condition which, in the opinion of the Investigator, may interfere with treatment, assessment, or compliance with the protocol.
Key Trial Info
Start Date :
February 11 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 11 2021
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT03317665
Start Date
February 11 2019
End Date
June 11 2021
Last Update
October 6 2021
Active Locations (3)
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1
Tampa General Hospital
Tampa, Florida, United States, 33606
2
University of South Florida - South Tampa Campus
Tampa, Florida, United States, 33606
3
University of South Florida Morsani Center for Advanced Health Care
Tampa, Florida, United States, 33612