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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEP-Arm | Experimental | 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. |
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| Placebo-Arm | Placebo Comparator | This arm will be used as control. The surgeon will inject 0.9% saline solution (5ml) in a blinded basis. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Platelet enriched plasma administration | Procedure | 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital General "Dr. Manuel Gea González" | Recruiting | Mexico City | 4800 | Mexico |
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| ID | Term |
|---|---|
| C563457 | Microtia-Anotia |
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| Placebo Arm | Procedure | 5 ml of saline 0.9%will be applied in the temporal fascia as a placebo used to compare to the experimental group. |
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