MedTrace Logo

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

NCT04597840 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2022-07-05

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Hospices Civils de Lyon

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-25
Primary Completion
2024-10-31
Completion
2024-10-31

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04597840 on ClinicalTrials.gov