Observational Biologic or Prosthetic Mesh



Status:Recruiting
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:3/30/2019
Start Date:February 11, 2019
End Date:June 2023
Contact:Thanh Tran, MPH
Email:thanhtran@health.usf.edu
Phone:8138448544

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Prospective, Observational Trial of Biological or Prosthetic Mesh for Open Ventral Hernia Repair

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.

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 standard. This is due to the high recurrence rates with all types of repairs,
especially primary suture repair. Because of this, most repairs are done with some type of
mesh, either made out of a prosthetic material or biologic material. Mesh repairs, however,
have their own problems, namely surgical site infections and potential bowel erosion.
Potential complications associated with prosthetic mesh for hernia repairs include: adverse
reactions to the mesh, mesh erosion, stricture formation, adhesions resulting in bowel
obstruction, enterocutaneous fistulas, injuries to nearby organs, nerves or blood vessels,
infection, chronic pain and hernia recurrence. Potential complications associated with
biological mesh include: adverse inflammatory response, laxity, eventration, and recurrent
herniation. To address these mesh related complications, the separation of components
technique was developed to reduce tension on the midline repair and the underlay technique
was developed to place the mesh in the retrorectus space. Nevertheless, this technique still
has a significant recurrence rate.

Therefore, the purpose of this study is to evaluate the effectiveness of biological or
prosthetic mesh in incisional hernia repair, by assessing the associated rates of hernia
recurrence and complications.

Inclusion Criteria:

- 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 Criteria:

- 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.
We found this trial at
3
sites
1 Tampa General Cir
Tampa, Florida 33606
(813) 844-7000
Principal Investigator: Vic Velanovich, MD
Phone: 813-844-7948
Tampa General Hospital In a diverse city known for its rich culture and beautiful beaches,...
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2 Tampa General Circle
Tampa, Florida 33606
Principal Investigator: Vic Velanovich, MD
Phone: 813-844-7948
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Tampa, FL
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13330 USF Laurel Drive
Tampa, Florida 33612
Principal Investigator: Vic Velanovich, MD
Phone: 813-844-7948
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Tampa, FL
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