Ear Cartilage, Microtia-Anotia, Platelets
Conditions
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.
Interventions
PROCEDUREPlatelet 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
PROCEDUREPlacebo Arm
5 ml of saline 0.9%will be applied in the temporal fascia as a placebo used to compare to the experimental group.
Sponsors
Hospital General Dr. Manuel Gea González
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
8 Years to 12 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Integration rate (in percentage) of the full thickness split graft sued during the second stage of auricular reconstruction. | evaluation will be at day 10 | Evaluation of the integration will be made on clinical basis, and evaluated by 3 experimented plastic surgeons. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complication | 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 |
Countries
Mexico
Outcome results
None listed