Use of Platelet-enriched Plasma During Auricular Reconstruction
NCT ID: NCT03215979
Last Updated: 2018-02-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
36 participants
INTERVENTIONAL
2017-06-29
2018-12-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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PEP-Arm
In this arm, surgeon will be applying platelet enriched plasma(PEP) (5 ml) during the second stage procedure of auricular reconstruction. PEP will be infected in the temporal fascia used to cover the cartilage frame.
Platelet enriched plasma administration
It is a blinded administration of platelet enriched plasma in the temporal fascia used to cover the auricular reconstruction frame, during the second stage of the procedure. The use of platelet enriched plasma is focused to improve the integration rate of the full-thickness split skin graft
Placebo-Arm
This arm will be used as control. The surgeon will inject 0.9% saline solution (5ml) in a blinded basis.
Placebo Arm
5 ml of saline 0.9%will be applied in the temporal fascia as a placebo used to compare to the experimental group.
Interventions
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Platelet enriched plasma administration
It is a blinded administration of platelet enriched plasma in the temporal fascia used to cover the auricular reconstruction frame, during the second stage of the procedure. The use of platelet enriched plasma is focused to improve the integration rate of the full-thickness split skin graft
Placebo Arm
5 ml of saline 0.9%will be applied in the temporal fascia as a placebo used to compare to the experimental group.
Eligibility Criteria
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Inclusion Criteria
* patients aged 8-12 years
* Haemoglobin \> 10 gr/dL
* History of first stage of auricular reconstruction
Exclusion Criteria
* desnutrition (\<2.5 gr/ dL)
8 Years
12 Years
ALL
No
Sponsors
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Hospital General Dr. Manuel Gea González
OTHER_GOV
Responsible Party
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Jorge Raúl Carrillo Córdova
Medical Doctor
Locations
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Hospital General "Dr. Manuel Gea González"
Mexico City, , Mexico
Countries
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Facility Contacts
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Other Identifiers
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05-20-2017
Identifier Type: -
Identifier Source: org_study_id
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