NCT03317665

Observational Biologic or Prosthetic Mesh

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 28 (actual)
• Sponsor: University of South Florida · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Ventral Incisional Hernia

Interventions

Type	Name	Description
DEVICE	Mesh for hernia repair	Permacol, Parietex, Progrip, Strattice Perforated, and Surgimend.

Timeline

• Start date: 2019-02-11
• Primary completion: 2021-06-11
• Completion: 2021-06-11
• First posted: 2017-10-23
• Last updated: 2021-10-06

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study