Contribution of PRF in CDH in Children With Prothetic Patch Closure

Congenital Diaphragmatic Hernias Clinical Trial

— HECODIAP  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03861182
• Other study ID #: 7067
• Status: Terminated
• Phase: Phase 3
• Start date: September 12, 2019
• Est. completion date: December 10, 2019

Study information

• Verified date: September 2019
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: December 10, 2019
• Est. primary completion date: December 10, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Congenital Diaphragmatic Hernias
• Hernia, Diaphragmatic
• Hernias, Diaphragmatic, Congenital

Intervention

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.

Locations

Country	Name	City	State
France	Hôpitaux Universitaires de Strasbourg	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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