Use of Platelet-enriched Plasma During Auricular Reconstruction

NCT03215979 | Unknown

• 1 other identifier: 05-20-2017
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Ear Cartilage; Platelets; Microtia-Anotia

Outcome Measures

Primary Outcomes (1)

• 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.

  evaluation will be at day 10

Secondary Outcomes (1)

• Complication

  evaluation will be at day 10

Study Arms (2)

PEP-Arm

EXPERIMENTAL

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

Placebo-Arm

PLACEBO COMPARATOR

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

Procedure: Placebo Arm

Interventions

Platelet enriched plasma administration PROCEDURE

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

PEP-Arm

Placebo Arm PROCEDURE

5 ml of saline 0.9%will be applied in the temporal fascia as a placebo used to compare to the experimental group.

Placebo-Arm

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Microtia Tanzer II-A
• patients aged 8-12 years
• Haemoglobin \> 10 gr/dL
• History of first stage of auricular reconstruction

You may not qualify if:

• associated endocrinopathies
• desnutrition (\<2.5 gr/ dL)

Sponsors & Collaborators

• Hospital General Dr. Manuel Gea González: lead

Study Sites (1)

Hospital General "Dr. Manuel Gea González"

Mexico City, 4800, Mexico

RECRUITING

MeSH Terms

Conditions

Microtia-Anotia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: July 7, 2017
• First Posted: July 12, 2017
• Study Start: June 29, 2017
• Primary Completion: November 29, 2018
• Study Completion: December 10, 2018
• Last Updated: February 22, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)