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Completed

NCT Number: NCT03316924

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

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.

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Key information

Conditions

Congenital Diaphragmatic Repair

Age range

0 year–14 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Les Hôpitaux Universitaires de Strasbourg

Strasbourg, 67098, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Foreskin resection

Procedure

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

Other names: orchidopexie, inguinal hernia repair

Primary outcomes

  1. cell colonization

    Time frame: samples are processed immediately after sampling

    Study cell colonization

  2. quality of the extracellular matrix

    Time frame: samples are processed immediately after sampling

    Quality of the extracellular matrix produced in vitro in contact with the currently used implant materials compared to biomaterials under development

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Oct 23, 2017
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.