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

NCT ID: NCT04597840

Last Updated: 2022-07-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-25
• Study Completion Date: 2024-10-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

biosynthetic mesh group

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.

Group Type: EXPERIMENTAL

Incisional hernia repair with reinforcement of biosynthetic mesh

Intervention Type: PROCEDURE

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.

standard of repair group

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

Group Type: OTHER

Incisional hernia repair with simple suture or synthetic mesh reinforcement.

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hôpital Lyon Sud

Pierre-Bénite, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Guillaume PASSOT, Pr

Role: CONTACT

guillaume.passot@chu-lyon.fr

4 78 86 23 71 ext. +33

Facility Contacts

Guillaume PASSOT, Pr

Role: primary

References

Passot G, Margier J, Kefleyesus A, Rousset P, Ortega-Deballon P, Renard Y, Bin S, Villeneuve L. Slowly absorbable mesh versus standard care in the management of contaminated midline incisional hernia (COMpACT-BIO): a multicentre randomised controlled phase III trial including a health economic evaluation. BMJ Open. 2022 Aug 25;12(8):e061184. doi: 10.1136/bmjopen-2022-061184.

Reference Type: DERIVED

PMID: 36008058 (View on PubMed)

Other Identifiers

69HCL20_0215

Identifier Type: -

Identifier Source: org_study_id