Study of Absorbable Biosynthetic Meshes in Contaminated Ventral Hernia Repair
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|ClinicalTrials.gov Identifier: NCT04132986|
Recruitment Status : Recruiting
First Posted : October 21, 2019
Last Update Posted : October 21, 2019
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.
|Condition or disease|
|Ventral Hernia Repair|
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Multicenter Descriptive Study of Absorbable Biosynthetic Meshes in Contaminated Ventral Hernia Repair|
|Actual Study Start Date :||April 1, 2019|
|Estimated Primary Completion Date :||April 2020|
|Estimated Study Completion Date :||April 2020|
- Retrospective analysis of resorbable biosynthetic prostheses [ Time Frame: iles analyzed retrospectily from May 1st, 2016 to May 31, 2018 will be examined ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04132986
|Contact: Benoît ROMAIN, MD||33 3 88 12 72 email@example.com|
|Service de chirurgie générale et digestive||Recruiting|
|Strasbourg, France, 67098|
|Contact: Benoît ROMAIN, MD 33 3 88 12 72 37 firstname.lastname@example.org|
|Principal Investigator: Benoît ROMAIN, MD|
|Sub-Investigator: Diane CHARLEUX-MULLER, MD|
|Sub-Investigator: Mahery RAHARIMANANTSOA, MD|
|Sub-Investigator: Vincent DUBUISSON, MD|
|Sub-Investigator: Pablo ORTEGA-DEBALLON, MD|
|Sub-Investigator: Yohann RENARD, MD|
|Sub-Investigator: Simone MANFREDELLI, MD|
|Sub-Investigator: Guillaume PASSOT, MD|
|Sub-Investigator: Cyril PERRENOT, MD|