NCT03215979

Use of Platelet-enriched Plasma During Auricular Reconstruction

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Hospital General Dr. Manuel Gea González · Other Government
• Sex: All
• Age: 8 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Ear Cartilage
• Platelets
• Microtia-Anotia

Interventions

Type	Name	Description
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
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.

Timeline

• Start date: 2017-06-29
• Primary completion: 2018-11-29
• Completion: 2018-12-10
• First posted: 2017-07-12
• Last updated: 2018-02-22

Locations

1 site across 1 country: Mexico