Use of Platelet-enriched Plasma During Auricular Reconstruction
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|ClinicalTrials.gov Identifier: NCT03215979|
Recruitment Status : Recruiting
First Posted : July 12, 2017
Last Update Posted : February 22, 2018
|Condition or disease||Intervention/treatment||Phase|
|Ear Cartilage Platelets Microtia-Anotia||Procedure: Platelet enriched plasma administration Procedure: Placebo Arm||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||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|
|Actual Study Start Date :||June 29, 2017|
|Estimated Primary Completion Date :||November 29, 2018|
|Estimated Study Completion Date :||December 10, 2018|
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
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 Comparator: Placebo-Arm
This arm will be used as control. The surgeon will inject 0.9% saline solution (5ml) in a blinded basis.
Procedure: 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.
- Integration rate (in percentage) of the full thickness split graft sued during the second stage of auricular reconstruction. [ Time Frame: evaluation will be at day 10 ]Evaluation of the integration will be made on clinical basis, and evaluated by 3 experimented plastic surgeons.
- Complication [ Time Frame: evaluation will be at day 10 ]It refers to a deviation from the normal course of the pathology, 3 complications will be taken into account: infection, seroma and hematoma
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): NCT03215979
|Hospital General "Dr. Manuel Gea González"||Recruiting|
|Mexico city, Mexico, 4800|
|Contact: Jorge Raúl Carrillo-Córdova, M.D 01 55 4000 3000 ext 1323 firstname.lastname@example.org|