Use of Platelet-enriched Plasma During Auricular Reconstruction

Study Overview
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Brief Summary
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In this study investigators are trying to determine the benefits of using platelet enriched plasma during the second stage of auricular reconstruction. The intervention will be blinded to the surgeon and the surgical team. The main outcome will be the evaluation of the integration rate of the skin full thickness graft used to coat the auricular frame.

Official Title
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Use of Platelet-enriched Plasma to Improve the Percentage of Integration of the Cutaneous Graft During Second Stage of Auricular Reconstruction in Children Aged 8-12 Years; A Controlled Clinical Trial

Conditions
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Ear Cartilage, Platelets, Microtia-Anotia

Intervention / Treatment
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* Procedure: Platelet enriched plasma administration
* Procedure: Placebo Arm


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Microtia Tanzer II-A patients aged 8-12 years Haemoglobin > 10 gr/dL History of first stage of auricular reconstruction Exclusion Criteria: associated endocrinopathies desnutrition (<2.5 gr/ dL)

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PEP-Arm<br>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. | Procedure: Platelet enriched plasma administration<br>* 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<br>|
| Placebo Comparator: Placebo-Arm<br>This arm will be used as control. The surgeon will inject 0.9% saline solution (5ml) in a blinded basis. | Procedure: Placebo Arm<br>* 5 ml of saline 0.9%will be applied in the temporal fascia as a placebo used to compare to the experimental group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Integration rate (in percentage) of the full thickness split graft sued during the second stage of auricular reconstruction. | Evaluation of the integration will be made on clinical basis, and evaluated by 3 experimented plastic surgeons. | evaluation will be at day 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication | It refers to a deviation from the normal course of the pathology, 3 complications will be taken into account: infection, seroma and hematoma | evaluation will be at day 10 |