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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
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

Brief 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.


Condition or disease
Ventral Hernia Repair

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia




Primary Outcome Measures :
  1. Retrospective analysis of resorbable biosynthetic prostheses [ Time Frame: iles analyzed retrospectily from May 1st, 2016 to May 31, 2018 will be examined ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient having been operated between May 2016 and September 2018 in a programmed or urgent surgery, as part of clean / contaminated to dirty surgery at mVHWG grade 3 in the centers participating in the study,
Criteria

Inclusion Criteria:

  • Patient whose age is ≥18 years,
  • Patient who has agreed to the use of his medical data for the purposes of this research,
  • Patient having been operated between May 2016 and September 2018 in a programmed or urgent surgery, as part of clean / contaminated to dirty surgery at mVHWG grade 3 in the centers participating in the study,
  • Patient who benefited between May 2016 and September 2018 from a biosynthetic mesh

Exclusion Criteria:

  • Patient who has not consented to the use of her medical data for the purposes of this research,
  • Patients who have benefited from the placement of a Phasix® ST biosynthetic mesh in intraperitoneal or Phasix® in retro-muscular prophylaxis,
  • Patient under safeguard of justice,
  • Patient under guardianship or curatorship.

Information from the National Library of Medicine

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


Contacts
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Contact: Benoît ROMAIN, MD 33 3 88 12 72 37 benoit.romain@chru-strasbourg.fr

Locations
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France
Service de chirurgie générale et digestive Recruiting
Strasbourg, France, 67098
Contact: Benoît ROMAIN, MD    33 3 88 12 72 37    benoit.romain@chru-strasbourg.fr   
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         
Sponsors and Collaborators
University Hospital, Strasbourg, France

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Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT04132986     History of Changes
Other Study ID Numbers: 7398
First Posted: October 21, 2019    Key Record Dates
Last Update Posted: October 21, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Strasbourg, France:
Ventral hernia repair
Contaminated surgery
Biosynthetic absorbable mesh
Descriptive study
Additional relevant MeSH terms:
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Hernia
Hernia, Ventral
Pathological Conditions, Anatomical
Hernia, Abdominal