Study for the Effects of Microcurrent Therapy on the Prevention and Healing of Brachioplasty Scars
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Assessing the change of POSAS Patient Scale Total Sum of Scores
研究概览
简要总结
Prospective, single-centre two-arm randomized controlled trial. Both groups receive standard wound care + hydration. The intervention group also receives microcurrent therapy. Patients with surgical incisions from bilateral Brachioplasty procedures will be included in this study. One arm will be randomized in the intervention group and one arm in the control group. Objective and subjective outcomes are registered. The aim of this study is to investigate whether the outcomes of the patients of the intervention group differ significantly from the patients in the control group.
详细描述
Study procedures:
Description of the clinical-investigation-related procedures in order of occurrence.
Measurements will be carried out at the following time-points:
- 15 days after surgery
- 90 days after surgery
- 180 days after surgery
Measurement procedures:
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subjects must be between 18 and 75 years old.
- •Having received surgical treatment, more specific bilateral brachioplasty.
排除标准
- •Subjects who have an implanted or other electrical stimulatory device such as pacemakers, or any other implanted electronic nerve, muscle or tissue stimulation.
- •Subjects with implanted hearing aids.
- •Subjects with a history of seizures, epilepsy.
- •Women who are pregnant at the time of enrolment
- •Central neurological conditions
- •Peripheral paralysis
- •Patients with diabetes mellitus
- •Subjects unable to give informed consent
结局指标
主要结局
Assessing the change of POSAS Patient Scale Total Sum of Scores
时间窗: At baseline (15 days after surgery) - 180 days after surgery.
The POSAS Patient Scale contains six items (pain, itch, colour, thickness, pliability, texture) that are scored numerically on a ten-step scale from 1 (= healthy skin) to 10 (= worst imaginable scar). Together they make up the 'Total Sum of Scores'.
次要结局
- POSAS Observer Scale Total Sum of Scores(At visit 1 (15 days after surgery) - at visit 2 (90 days after surgery) - at visit 3 (180 days after surgery))
- Elasticity measurement with Cutometer(At visit 1 (15 days after surgery) - at visit 2 (90 days after surgery) - at visit 3 (180 days after surgery))
- Disease specific assessment of Quality of Life with DLQI(At visit 1 (15 days after surgery) - at visit 2 (90 days after surgery) - at visit 3 (180 days after surgery))
- Colour measurement with MexaMeter(At visit 1 (15 days after surgery) - at visit 2 (90 days after surgery) - at visit 3 (180 days after surgery))
- Generic assessment of Quality of Life with EQ5D(At visit 1 (15 days after surgery) - at visit 2 (90 days after surgery) - at visit 3 (180 days after surgery))