Analysis of in Vitro Biological Reaction of Diaphragmatic Prothesis When Congenital Diaphragmatic Hernia (CDH) Repair

Mecanical Properties of Biomaterials and Biological Integration of Diaphragmatic Prothesis in Infancy

In case of CDH, the incomplete development of a part of the diaphragm allows abdominal viscera to herniate into thorax cavity during fetal development and impaired lung and heart development.

After birth, CDH patients who survived thanks to an active reanimation management undergo diaphragmatic repair. In case of large defect, a patch is needed to complete diaphragmatic closure. Thanks to primary cell culture from foreskin, peritoneal epithelium or cremaster dedicated to incineration investigators want to analyse biological integration of actually used prothesis and others innovations.

Study Overview

• Status: Completed
• Conditions: Congenital Diaphragmatic Repair
• Intervention / Treatment: Procedure: Foreskin resection

• Study Type: Observational
• Enrollment (Actual): 1

Contacts and Locations

• Study Contact: Name: Isabelle TALON, MD; Phone Number: +33 3 88 12 72 96; Email: isabelle.talon2@chru-strasbourg.fr
• Study Contact Backup: Name: Anne SCHNEIDER, MD; Phone Number: +33 3 88 12 72 93; Email: anne.schneider1@chru-strasbourg.fr

Study Locations

• France
  • Strasbourg, France, 67098
    • Les Hôpitaux Universitaires de Strasbourg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 14 years (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Children that benefits of a foreskin resection, inguinal hernia repair or orchidopexy

Description

Inclusion Criteria:

• Minor aged 0 (day of birth) to 14 years
• Patient for whom an indication of posthectomy and / or cure of inguinal hernia and / or testicular ectopy is retained
• Patient whose legal representatives have agreed to the use of operational waste from mesenchymal tissues (foreskin, cremaster and peritoneum) destined for incineration.
• Patient affiliated to a social security scheme

Exclusion Criteria:

- parents don't agree to the use of its operating waste for research purposes

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cell colonization	Study cell colonization	samples are processed immediately after sampling
quality of the extracellular matrix	Quality of the extracellular matrix produced in vitro in contact with the currently used implant materials compared to biomaterials under development	samples are processed immediately after sampling

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France
• Investigators: Principal Investigator: Isabelle TALON, MD, Les Hôpitaux Universitaires de Strasbourg

Study record dates

Study Major Dates

• Study Start (Actual): May 29, 2018
• Primary Completion (Actual): May 29, 2023
• Study Completion (Actual): May 31, 2023

Study Registration Dates

• First Submitted: October 17, 2017
• First Submitted That Met QC Criteria: October 20, 2017
• First Posted (Actual): October 23, 2017

Study Record Updates

• Last Update Posted (Actual): July 14, 2023
• Last Update Submitted That Met QC Criteria: July 13, 2023
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 6834

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No