NCT04597840

Biosynthetic Absorbable Mesh vs Standard of Repair for the Surgical Treatment of Infected Incisional Hernia

Multicenter, Prospective, Longitudinal and Randomized Comparison of Both the Clinical and Economic Impact of Biosynthetic Absorbable Mesh to the Surgical Standard of Care in Contaminated Incisional Hernia Repair

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 108 (estimated)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Incisional hernia is one of the most common complications of abdominal surgery and carries a significant burden for both patients and the economic health service. However, no consensus for the surgical treatment of incisional hernia in contaminated field is currently available. The purpose of the COMpACT-BIO study is to investigate the clinical and economic benefit of the use of biosynthetic mesh in contaminated incisional hernia repair.

Detailed description

The current standard of incisional hernia repair is reinforcement with permanent synthetic mesh. However, permanent synthetic mesh is contraindicated in contaminated surgical field due to higher risk of postoperative infection. In order to resist to infection, absorbable meshes, such as biological and biosynthetic meshes, have been developped. However, some controversies exist about the clinical benefit of biological meshes in the long term. Reasons for theses controversies are their overall risk of complication and recurrence and the lack of consensus in which surgical technique to apply. Moreover, the financial cost of biological meshes is very high. Recently developed, biosynthetic meshes appear to be a promising option ; Compared to biological meshes, they seem to have several advantages. However, such data demonstrating the beneficial use of biosynthetic mesh in contaminated incisional hernia repair is not available. In this regard, the COMpACT-BIO study aims to investigate the clinical and economic benefit of the use of biosynthetic mesh in contaminated incisional hernia repair in comparison to the standard of repair. This is a multicenter, prospective, longitudinal and randomized study, which also offers a standardized technique of repair.

Conditions

• Ventral Hernia Repair

Interventions

Type	Name	Description
PROCEDURE	Incisional hernia repair with reinforcement of biosynthetic mesh	The biosynthetic mesh (Phasix or Bio-A meshes) will be placed as a sublay in the retromuscular position to reinforce midline fascial closure. All the surgical procedure (including placement and fixation of the mesh) will be performed according to a standardized protocol.
PROCEDURE	Incisional hernia repair with simple suture or synthetic mesh reinforcement.	Based on the discretion of the surgeon, the incisional hernia repair will be done by simple suture or by synthetic mesh reinforcement. All the surgical procedure (including placement and fixation of the mesh if applicable) will be performed according to a standardized protocol.

Timeline

• Start date: 2021-05-25
• Primary completion: 2024-10-01
• Completion: 2024-10-01
• First posted: 2020-10-22
• Last updated: 2022-07-05

Locations

1 site across 1 country: France