Contribution of PRF in CDH in Children With Prothetic Patch Closure

Phase 3TerminatedNCT03861182

University Hospital, Strasbourg, France30 enrolled

Overview

Improved management of giant congenital diaphragmatic hernias (CDH) in neonates : decreased risk of morbidity and mortality due to prosthesis release. CDH is a rare disease with a still very dark prognosis, with a high rate of morbidity and mortality in giants forms linked to the release of insufficiently biologically integrated prosthesis. The biological functionalization of the prosthetic materials by host PRF would improve the biological colonization of materials and thus reduce the risk of prosthetic release.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Congenital Diaphragmatic Hernias

Interventions

Biological functionalization of the prosthetic materials by PRFBIOLOGICAL

The biological functionalization of the prosthetic materials by host PRF would improve the biological colonization of materials and thus reduce the risk of prosthetic release.

Eligibility

Sex: ALLMin age: 1 DayHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: Adult Healthy Volunteers : \- Over 18 years of age Neonates: * Aged between 1h of life and 28 days of life * Born beyond 33 Week of Amenorrhea + 1day and 2kg of birth weight * Hospitalized in the medical-surgical centre of Pediatrics of the hospital of Strasbourg * For whom a blood sample was prescribed as part of their routine care Exclusion Criteria: Adult Healthy Volunteers : * Systemic inflammatory disease * Transient inflammatory state * Any drug that modifies the coagulation cascade during the 48h preceding the sampling Neonates: * Risk of anemia \< 7g/DL * Current anticoagulant treatment

Locations (1)

Hôpitaux Universitaires de Strasbourg

Strasbourg, France

Outcomes

Primary Outcomes

Comparison of cell colonization between neonate biomaterials and the same biomaterials functionalized by Platelet Rich Fibrin of healthy adult volunteers.

Analysis of cell colonization after cell culture.

Time frame: 7 days

Data from ClinicalTrials.gov

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