NCT01092468已完成2 期
Prospective, Randomised, Single-blinded Study : Comparison of Harmonic Scalpel to Conventional Diathermy in Perforator Flap
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- flap elevation time: from identification of skin perforator to completion of dissection to main pedicle
研究概览
简要总结
This study is to compare the efficacy of Harmonic Scalpel with conventional diathermy technique in terms of reducing elevation time and perioperative complications of perforator flaps for head and neck reconstruction.
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •head and neck reconstruction with perforator flap
- •informed consent from the patient
排除标准
- •coagulation problem
- •refused to participate
研究组 & 干预措施
Diathermy
Placebo Comparator
Perforator flap elevation using conventional diathermy technique
干预措施: Diathermy (Procedure)
Harmonic Scalpel
Active Comparator
Perforator flap elevation using Harmonic Scalpel
干预措施: Harmonic Scalpel (Procedure)
结局指标
主要结局
flap elevation time: from identification of skin perforator to completion of dissection to main pedicle
时间窗: 1 hour after completion of flap elevation
次要结局
- postoperative drainage amount(1 week after flap inset)
- postoperative pain measured by visual analogue scale (VAS)(1 week after completion of flap elevation)
- intraoperative complications: bleeding, perforator injury (thermal, mechanical)(1 hour after completion of flap elevation)
研究者
Man Ki Chung
Assistant professor
Samsung Medical Center
研究点 (1)
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