Use of Platelet-enriched Plasma During Auricular Reconstruction

Not Applicable

• Conditions: Platelets; Ear Cartilage; Microtia-Anotia
• Interventions: Procedure: Platelet enriched plasma administration; Procedure: Placebo Arm

• Registration Number: NCT03215979
• Lead Sponsor: Hospital General Dr. Manuel Gea González

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-29
• Study First Submitted: 2017-07-07
• Study First Submitted QC: 2017-07-11
• Study First Posted: 2017-07-12
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-20
• Last Update Posted: 2018-02-22
• Primary Completion: 2018-11-29
• Study Completion: 2018-12-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 36

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PEP-Arm	Platelet enriched plasma administration	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.
Placebo-Arm	Placebo Arm	This arm will be used as control. The surgeon will inject 0.9% saline solution (5ml) in a blinded basis.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Complication	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

Trial Locations

Locations (1)

Hospital General "Dr. Manuel Gea González"; 🇲🇽 Mexico city, Mexico