Use of Platelet-enriched Plasma During Auricular Reconstruction

February 20, 2018 updated by: Jorge Raúl Carrillo Córdova, Hospital General Dr. Manuel Gea González

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Mexico city, Mexico, 4800
        • Recruiting
        • Hospital General "Dr. Manuel Gea González"
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PEP-Arm
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
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
Placebo Comparator: Placebo-Arm
This arm will be used as control. The surgeon will inject 0.9% saline solution (5ml) in a blinded basis.
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complication
Time Frame: 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
evaluation will be at day 10

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital General Dr. Manuel Gea González

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 29, 2017

Primary Completion (Anticipated)

November 29, 2018

Study Completion (Anticipated)

December 10, 2018

Study Registration Dates

First Submitted

July 7, 2017

First Submitted That Met QC Criteria

July 11, 2017

First Posted (Actual)

July 12, 2017

Study Record Updates

Last Update Posted (Actual)

February 22, 2018

Last Update Submitted That Met QC Criteria

February 20, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05-20-2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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