Use of Platelet-enriched Plasma During Auricular Reconstruction

Hospital General Dr. Manuel Gea González

Status: Unknown

Conditions: Microtia-Anotia; Platelets; Ear Cartilage

Treatments: Procedure: Platelet enriched plasma administration; Procedure: Placebo Arm

Study type: Interventional

Funder types: Other

Identifiers

NCT03215979

05-20-2017

Details and patient eligibility

About

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.

Enrollment: 36 estimated patients

Sex: All

Ages: 8 to 12 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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36 participants in 2 patient groups, including a placebo group

PEP-Arm

Experimental group

Description:

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.

Treatment:

Procedure: Platelet enriched plasma administration

Placebo-Arm

Placebo Comparator group

Description:

This arm will be used as control. The surgeon will inject 0.9% saline solution (5ml) in a blinded basis.

Treatment:

Procedure: Placebo Arm