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Clinical Trial Summary

The potential value of biological and biosynthetic meshes is their ability to integrate and remodel the wall in a contaminated environment in complex surgical situations. However, postoperative morbidity and recurrence rate for biologic prostheses are high. The delay to evaluate biosynthetic prostheses is not enough at present, and the high cost of biological prostheses requires a parsimonious use of this type of material. The interest of absorbable biosynthetic prostheses remains to be demonstrated in terms of postoperative complications and long-term recurrence. Current studies have been done on groups with few subjects and in clean surgery. The primary purpose is to describe the number of complications of the operative site at 12 months, including infectious and noninfectious complications as hematoma and seroma type. The secondary purpose is to describe the number of recurrent ventral hernia at 12 months. The ventral hernia repair is a frequent operation of general surgery. Thanks to this descriptive work considering the new therapeutic offer with absorbable polymers, it would make possible to update the knowledge of the surgeons and to bring new elements of discussion in the surgical decision.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT04132986
Study type Observational
Source University Hospital, Strasbourg, France
Contact Benoît ROMAIN, MD
Phone 33 3 88 12 72 37
Email benoit.romain@chru-strasbourg.fr
Status Recruiting
Phase
Start date April 1, 2019
Completion date June 30, 2023

See also
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Terminated NCT01981044 - SERI® Surgical Scaffold Postmarket Study of Soft Tissue Support in Ventral Hernia Repair N/A
Recruiting NCT04597840 - Biosynthetic Absorbable Mesh vs Standard of Repair for the Surgical Treatment of Infected Incisional Hernia N/A
Completed NCT03945357 - Reducing INfection at the Surgical SitE With Antibiotic Irrigation During Ventral Hernia Repair (RINSE Trial) Phase 3
Suspended NCT02505204 - PVB With vs. Without Clonidine for Ventral Hernia Repair N/A