Use of Platelet-enriched Plasma During Auricular Reconstruction

Overview

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.

Full Title of Study: “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”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Treatment
  • Masking: Double (Participant, Investigator)
• Study Primary Completion Date: November 29, 2018

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.

Arms, Groups and Cohorts

• 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.
• Placebo Comparator: Placebo-Arm
  • This arm will be used as control. The surgeon will inject 0.9% saline solution (5ml) in a blinded basis.

Clinical Trial Outcome Measures

Primary Measures

• 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 Measures

• 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

Participating in This Clinical Trial

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 Eligibility: All

Minimum Age: 8 Years

Maximum Age: 12 Years

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Hospital General Dr. Manuel Gea González
• Provider of Information About this Clinical Study
  • Principal Investigator: Jorge Raúl Carrillo Córdova, Medical Doctor – Hospital General Dr. Manuel Gea González