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Use of Platelet-enriched Plasma During Auricular Reconstruction

NCT03215979 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2018-02-22

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Hospital General Dr. Manuel Gea González

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-29
Primary Completion
2018-11-29
Completion
2018-12-10

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03215979 on ClinicalTrials.gov