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Use of Platelet-enriched Plasma During Auricular Reconstruction

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ClinicalTrials.gov Identifier: NCT03215979
Recruitment Status : Recruiting
First Posted : July 12, 2017
Last Update Posted : October 24, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Ear Cartilage Platelets Microtia-Anotia Procedure: Platelet enriched plasma administration Procedure: Placebo Arm

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : June 29, 2017
Estimated Primary Completion Date : November 29, 2017
Estimated Study Completion Date : December 10, 2017

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U.S. FDA Resources

Arms and Interventions

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.


Outcome Measures

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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


Eligibility Criteria

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Ages Eligible for Study:   8 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03215979


Locations
Mexico
Hospital General "Dr. Manuel Gea González" Recruiting
Mexico city, Mexico, 4800
Contact: Jorge Raúl Carrillo-Córdova, M.D    01 55 4000 3000 ext 1323    dr.carrillo.plastica@gmail.com   
Sponsors and Collaborators
Hospital General Dr. Manuel Gea González
Dr. Armando Apellaniz
More Information

Responsible Party: Jorge Raúl Carrillo Córdova, Medical Doctor, Hospital General Dr. Manuel Gea González
ClinicalTrials.gov Identifier: NCT03215979     History of Changes
Other Study ID Numbers: 05-20-2017
First Posted: July 12, 2017    Key Record Dates
Last Update Posted: October 24, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Congenital Microtia
Ear Diseases
Otorhinolaryngologic Diseases
Congenital Abnormalities