NCT00778947撤回不适用
Comparison of Harmonic Scalpel to Conventional Diathermy in Free Tissue Transfer for Breast Reconstruction
St Andrew's Centre for Plastic Surgery1 个研究点 分布在 1 个国家开始时间: 2008年11月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- The speed of flap harvest measured as the time from "knife to skin" to the flap being removed from the patient.
研究概览
简要总结
The purpose of this single centre study is to evaluate whether the use of Harmonic Synergy Dissecting Hook (Harmonic Scalpel) in breast reconstruction surgery is superior to conventional diathermy in terms of improving ease and speed of perforator dissection, reducing postoperative pain, days of hospital stay and time taken to return to daily activities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients aged between 18 and 80 years old
- •Able to comprehend, follow, and provide written informed consent.
- •Willingness to comply with study requirements including follow-up visits
排除标准
- •Patients who have a pacemaker
- •Pregnant or breast feeding females.
- •General contraindication for surgery as deemed by the PI (e.g. physically unfit)
- •Patients who smoke
- •Diabetic patients
- •Patients who are receiving permanent analgesics
- •Patients receiving anti-coagulation therapy.
- •Patients with a physical or psychological condition which would impair participation in the study.
- •Participation in any other device or drug study within 90 days prior to enrollment.
- •Planned participation in any other medical device study during the timeframe of this study.
结局指标
主要结局
The speed of flap harvest measured as the time from "knife to skin" to the flap being removed from the patient.
时间窗: At surgery
次要结局
- Incidence of seroma(post operation for 6 months)
- Number of days of hospitalisation(post operation for 6 months)
- Return to theatre(post operation for 6 months)
- Incidence of abdominal (donor site) wound dehiscence(post operation for 6 months)
- Bleeding complications(intra operation and for 6 months post op)
- Ease of flap harvest: the subjective opinion of the surgeon based on structured questionnaire(At surgery)
- Post operative pain, based on the visual analogue scale at 3, 6, 12 and 24 weeks post operatively.(3, 6, 12 and 24 weeks post operation)
- Rates of post operative infection(post operation for 6 months)
- Impact on daily activities (SF-36 Questionnaire) at 3, 6, 12 and 24 weeks post operatively(3, 6, 12, and 24 weeks post operation)
- Post operative drainage from the wound(post operation for 6 months)
- Re-operation required(post operation for 6 months)
研究者
研究点 (1)
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