Observational Biologic or Prosthetic Mesh

University of South Florida

Status: Terminated

Conditions: Ventral Incisional Hernia

Treatments: Device: Mesh for hernia repair

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03317665

CA2017-003

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

28 participants in 1 patient group

Standard of care

Description:

Mesh for hernia repair: Standard of care products used by the Investigator for open ventral hernia repair procedure

Treatment:

Device: Mesh for hernia repair