Biosynthetic Absorbable Mesh vs Standard of Repair for the Surgical Treatment of Infected Incisional Hernia (COMpACT-BIO)

Civil Hospices of Lyon

Status: Enrolling

Conditions: Ventral Hernia Repair

Treatments: Procedure: Incisional hernia repair with simple suture or synthetic mesh reinforcement.; Procedure: Incisional hernia repair with reinforcement of biosynthetic mesh

Study type: Interventional

Funder types: Other

Identifiers

NCT04597840

69HCL20_0215

Details and patient eligibility

About

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.

Full 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.

Enrollment: 108 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

All the following inclusion criteria must be fulfilled:

• Age ≥18 years old
• Physical status ASA < 4
• Patient with a mid-line IH
• Patient presenting with an IH without loss of domain
• Surgical indication in elective surgery
• "Potentially contaminated" grade III surgical environment according to the classification of the modified VHWG
• Cure of mid line IH feasible according to the defined standard technical modality (placement of a retromuscular prosthesis)
• No emergency surgical procedure
• Status of social insured or entitled to a social insurance
• Informed and signed consent of the patient after clear and appropriate information

The exclusion criteria are as follows:

• One or multiple incisional hernia out of the midline incision
• Pregnancy, breastfeeding, parturient or childbearing patients without contraception
• Known allergy to tetracyclines;
• Persons protected by law

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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108 participants in 2 patient groups

biosynthetic mesh group

Experimental group

Description:

Patient will undergo incisional hernia repair with biosynthetic mesh reinforcement. Based on the discretion of the surgeon, two types of biosynthetic mesh from different brand can be used: the Phasix mesh from BARD or the BioA mesh from GORE. These two biosynthetic meshes are resorbable, which means they are gradually absorbed by the body.

Treatment:

Procedure: Incisional hernia repair with reinforcement of biosynthetic mesh

standard of repair group

Other group

Description:

Patient will undergo incisional hernia repair according to the standard of repair, which is simple suture or mesh reinforcement (using synthetic or biological meshes).

Treatment:

Procedure: Incisional hernia repair with simple suture or synthetic mesh reinforcement.