Use of Platelet-enriched Plasma During Auricular Reconstruction

Brief Title

Use of Platelet-enriched Plasma During Auricular Reconstruction

Official Title

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

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.
    



Study Type

Interventional


Primary Outcome

Integration rate (in percentage) of the full thickness split graft sued during the second stage of auricular reconstruction.

Secondary Outcome

 Complication

Condition

Ear Cartilage

Intervention

Platelet enriched plasma administration

Study Arms / Comparison Groups

 PEP-Arm
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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

36

Start Date

June 29, 2017

Completion Date

December 10, 2018

Primary Completion Date

November 29, 2018

Eligibility Criteria

        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)
      

Gender

All

Ages

8 Years - 12 Years

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

Mexico

Location Countries

Mexico

Administrative Informations


NCT ID

NCT03215979

Organization ID

05-20-2017


Responsible Party

Principal Investigator

Study Sponsor

Hospital General Dr. Manuel Gea González


Study Sponsor

, , 


Verification Date

February 2018