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
试验速览
- 阶段
- 不适用
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Integration rate (in percentage) of the full thickness split graft sued during the second stage of auricular reconstruction.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 8 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Microtia Tanzer II-A
- •patients aged 8-12 years
- •Haemoglobin > 10 gr/dL
- •History of first stage of auricular reconstruction
排除标准
- •associated endocrinopathies
- •desnutrition (<2.5 gr/ dL)
研究组 & 干预措施
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.
干预措施: Platelet enriched plasma administration (Procedure)
Placebo-Arm
This arm will be used as control. The surgeon will inject 0.9% saline solution (5ml) in a blinded basis.
干预措施: Placebo Arm (Procedure)
结局指标
主要结局
Integration rate (in percentage) of the full thickness split graft sued during the second stage of auricular reconstruction.
时间窗: evaluation will be at day 10
Evaluation of the integration will be made on clinical basis, and evaluated by 3 experimented plastic surgeons.
次要结局
- Complication(evaluation will be at day 10)
研究者
Jorge Raúl Carrillo Córdova
Medical Doctor
Hospital General Dr. Manuel Gea González