Use of Platelet-enriched Plasma During Auricular Reconstruction

Platelets Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03215979
• Other study ID #: 05-20-2017
• Status: Recruiting
• Phase: N/A
• First received: July 7, 2017
• Last updated: February 20, 2018
• Start date: June 29, 2017
• Est. completion date: December 10, 2018

Study information

• Verified date: February 2018
• Source: Hospital General Dr. Manuel Gea González
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: December 10, 2018
• Est. primary completion date: November 29, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

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)

Related Conditions & MeSH terms

• Ear Cartilage
• Microtia-Anotia
• Platelets

Intervention

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 Arm
5 ml of saline 0.9%will be applied in the temporal fascia as a placebo used to compare to the experimental group.

Locations

Country	Name	City	State
Mexico	Hospital General "Dr. Manuel Gea González"	Mexico city

Sponsors (1)

Lead Sponsor	Collaborator
Hospital General Dr. Manuel Gea González

Country where clinical trial is conducted

Mexico, 

Outcome

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