An interventional study of Platelet enriched plasma administration and Placebo Arm in Ear Cartilage, Platelets and Microtia-Anotia, sponsored by Hospital General Dr. Manuel Gea González. Status unknown at 1 site in Mexico. Open to participants aged 8 Years to 12 Years. Per ClinicalTrials.gov, last updated 2018-02-22.
Sponsored by Hospital General Dr. Manuel Gea González · Not applicable, Interventional, and Treatment
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.
Hospital General Dr. Manuel Gea González is the lead sponsor of 2 studies on the registry; none are open to participants now.
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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
This arm will be used as control. The surgeon will inject 0.9% saline solution (5ml) in a blinded basis.
Procedure: Placebo Arm
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
5 ml of saline 0.9%will be applied in the temporal fascia as a placebo used to compare to the experimental group.
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.
Time frame: evaluation will be at day 10
Complication
It refers to a deviation from the normal course of the pathology, 3 complications will be taken into account: infection, seroma and hematoma
Time frame: evaluation will be at day 10
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2017 (actual). Primary completion is estimated for Nov 2018, 17 months after the start.
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This study is status unknown, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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Microtia-Anotia
Hospital General Dr. Manuel Gea González