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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03861182
Recruitment Status : Terminated (Lack of staff)
First Posted : March 4, 2019
Last Update Posted : January 19, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Congenital Diaphragmatic Hernias Biological: Biological functionalization of the prosthetic materials by PRF Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Contribution of PRF (Platelet Rich Fibrin) in the Biological Functionalization of Prothetic Patch Closure : in Vitro Study
Actual Study Start Date : September 12, 2019
Actual Primary Completion Date : December 10, 2019
Actual Study Completion Date : December 10, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arms and Interventions
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Arm Intervention/treatment
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.
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.


Outcome Measures
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Primary Outcome Measures :
  1. Comparison of cell colonization between neonate biomaterials and the same biomaterials functionalized by Platelet Rich Fibrin of healthy adult volunteers. [ Time Frame: 7 days ]
    Analysis of cell colonization after cell culture.


Eligibility Criteria
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Ages Eligible for Study:   1 Day and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03861182


Locations
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France
Hôpitaux Universitaires de Strasbourg
Strasbourg, France, 67 091
Sponsors and Collaborators
University Hospital, Strasbourg, France
More Information
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Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT03861182    
Other Study ID Numbers: 7067
First Posted: March 4, 2019    Key Record Dates
Last Update Posted: January 19, 2021
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hernias, Diaphragmatic, Congenital
Hernia, Diaphragmatic
Hernia
 Pathological Conditions, Anatomical
Internal Hernia
Congenital Abnormalities