Use of Platelet-enriched Plasma During Auricular Reconstruction

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03215979
• Date of registration: 07/07/2017
• Prospective Registration: No
• Primary sponsor: Hospital General Dr. Manuel Gea González
• Public title: Use of Platelet-enriched Plasma During Auricular Reconstruction
• Scientific 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
• Date of first enrolment: June 29, 2017
• Target sample size: 36
• Recruitment status: Unknown status
• URL: https://clinicaltrials.gov/show/NCT03215979
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: N/A

Countries of recruitment

Mexico

Contacts

• Name: Jorge Raúl Carrillo-Córdova, M.D

Key inclusion & exclusion 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)



Age minimum: 8 Years
Age maximum: 12 Years
Gender: All

Health Condition(s) or Problem(s) studied

Ear Cartilage

Microtia-Anotia

Platelets

Intervention(s)

Procedure: Placebo Arm

Procedure: Platelet enriched plasma administration

Primary Outcome(s)

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]

Secondary Outcome(s)

Complication [Time Frame: evaluation will be at day 10]

Secondary ID(s)

05-20-2017

Source(s) of Monetary Support

Please refer to primary and secondary sponsors