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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Congenital Diaphragmatic Hernias | Biological: Biological functionalization of the prosthetic materials by PRF | Phase 3 |
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 |

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. |
- 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

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
France | |
Hôpitaux Universitaires de Strasbourg | |
Strasbourg, France, 67 091 |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Hernias, Diaphragmatic, Congenital Hernia, Diaphragmatic Hernia Pathological Conditions, Anatomical Congenital Abnormalities |