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

NCT04597840 | Unknown

• 1 other identifier: 69HCL20_0215
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventral Hernia Repair

Keywords

ventral hernia repair; contaminated surgical field; infected incisional hernia; biosynthetic mesh

Outcome Measures

Primary Outcomes (1)

• Rate of incisional hernia recurrence

  The rate of incisional hernia recurrence will be evaluated by radiologic imaging.

  3 years after surgery

Secondary Outcomes (9)

• Days of hospitalization related to incisional hernia repair

  For 3 years after surgery

• Incidence of re-operation related to incisional hernia repair

  For 3 years after surgery

• Incidence of wound events

  1 month from surgery date, then 3-, 6- 12-, 24- and 36 months from surgery date

• Incidence of revision surgery or interventional radiologic procedure

  1 month from surgery date, then 3-, 6- 12-, 24- and 36 months from surgery date

• Rate of early incisional hernia recurrence

  1 month from surgery date, then 3-, 6- 12-, 24- and 36 months from surgery date

Study Arms (2)

biosynthetic mesh group

EXPERIMENTAL

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.

Procedure: Incisional hernia repair with reinforcement of biosynthetic mesh

standard of repair group

OTHER

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

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

Interventions

Incisional hernia repair with reinforcement of biosynthetic mesh 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.

biosynthetic mesh group

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

standard of repair group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hôpital Lyon Sud

Pierre-Bénite, 69310, France

RECRUITING

Related Publications (1)

• 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.

  PMID: 36008058 DERIVED

Central Study Contacts

Guillaume PASSOT, Pr

CONTACT

4 78 86 23 71; guillaume.passot@chu-lyon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The type of incisional hernia repair (simple suture or mesh reinforcement) will be masked to the primary outcome assessor.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2020
• First Posted: October 22, 2020
• Study Start: May 25, 2021
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: July 5, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)