Contribution of PRF in CDH in Children With Prothetic Patch Closure (HECODIAP)

Contribution of PRF (Platelet Rich Fibrin) in the Biological Functionalization of Prothetic Patch Closure : in Vitro Study

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 Overview

• Status: Terminated
• Conditions: Congenital Diaphragmatic Hernias
• Intervention / Treatment: Biological: Biological functionalization of the prosthetic materials by PRF

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Strasbourg, France, 67 091
    • Hopitaux Universitaires de Strasbourg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Adult Healthy Volunteers	Biological: Biological functionalization of the prosthetic materials by PRF; 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.
Other: Neonates	Biological: Biological functionalization of the prosthetic materials by PRF; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	7 days

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2019
• Primary Completion (Actual): December 10, 2019
• Study Completion (Actual): December 10, 2019

Study Registration Dates

• First Submitted: January 24, 2019
• First Submitted That Met QC Criteria: February 28, 2019
• First Posted (Actual): March 4, 2019

Study Record Updates

• Last Update Posted (Actual): January 19, 2021
• Last Update Submitted That Met QC Criteria: January 14, 2021
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Pathological Conditions, Anatomical; Internal Hernia; Hernia; Hernias, Diaphragmatic, Congenital; Hernia, Diaphragmatic
• Other Study ID Numbers: 7067

Drug and device information, study documents

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