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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03316924
Enrollment
1
Registered
2017-10-23
Start date
2018-05-29
Completion date
2023-05-31
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Diaphragmatic Repair

Brief summary

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.

Interventions

PROCEDUREForeskin resection

During the pediatric surgery consultation, the doctor will decide between Foreskin resection, orchidopexie or inguinal hernia repair.

Sponsors

University Hospital, Strasbourg, France
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
0 Years to 14 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
cell colonizationsamples are processed immediately after samplingStudy cell colonization
quality of the extracellular matrixsamples are processed immediately after samplingQuality of the extracellular matrix produced in vitro in contact with the currently used implant materials compared to biomaterials under development

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026