Endermotherapy With Burn Hypertrophic Scars
| 追踪信息 | |||
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| 首次提交日期 ICMJE | March 22, 2018 | ||
| 首次发布日期e ICMJE | October 5, 2018 | ||
| 最后更新发布日期 | October 5, 2018 | ||
| 预计研究开始日期 ICMJE | February 13, 2017 | ||
| 预计主要完成日期 | February 13, 2020 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
Skin Thickness Changes[ Time Frame: baseline, 12, 24 and 36 weeks ] Ultrasound skin measures, mm |
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| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
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| 描述性信息 | |||
| 简略标题 ICMJE | Endermotherapy With Burn Hypertrophic Scars | ||
| 正式标题 ICMJE | Randomized, Controlled, Within-patient, Singleblind Study to Evaluate the Efficacy of 12-weeks of Endermotherapy With Adult Burn Survivors | ||
| 简要概况 | Mechanical massage or endermotherapyTM is applied to scar tissue with the intended therapeutic value being the promotion of structural or physiological changes. These proposed changes are meant to induce more pliability, so that skin possesses the strength and elasticity required for normal mobility. The advantage of mechanical massage compared to manual massage is that it provides a standard dosage using rollers and suction valves to mobilize the tissue. However, research documenting and supporting this effect is lacking. The objective of this proposal is to document the effect of 12 weeks of endermotherapy treatment on hypertrophic scar characteristics, including erythema, pigmentation, pliability, and thickness in adult burn survivors and their subjective evaluation of itch, pain and overall scar outcome through a prospective, randomized, controlled, within-patient, single-blinded study. |
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| 详细说明 | Patients will receive 12 weeks of endermotherapy , 3 times a week. | ||
| 研究类型 ICMJE | Interventional | ||
| 研究阶段 | N/A | ||
| 研究设计 ICMJE | 分配: Randomized 干预模型: Parallel Assignment 干预模型描述: 盲法: Interventional 盲法描述: 主要目的: Treatment |
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| 研究工具 |
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| 招募信息 | |||
| 招募状态 ICMJE | Recruiting | ||
| 预计入组 ICMJE |
48 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | March 13, 2020 | ||
| 预计主要完成日期 | February 13, 2020 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: - females and males, of any race, 14 years or older, - a thermal injury, - at least 3 months post-burn so that the scars will be durable enough to tolerate the proposed forces, - at least 2 scar sites >2.034 mm thick and within 0.5 mm of each other, and - signed the informed patient consent form Exclusion Criteria: - subjects who have keloids, - with a diagnosis of psychiatric illness clearly documented in their medical file, - mechanism of injury is an electrical, chemical, or cold injury, - a dermatological conditions in the region of the evaluation site, that may interfere with the study results, - a suspected or known allergy to ultrasound gel, - unable to understand French or English, or - subjects who refuse to give informed consent. | ||
| 性别 |
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| 年龄 | 最小年龄：14 Years ，最大年龄：N/A | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | Canada | ||
| 管理信息 | 数据检测委员会 | ||
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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| IPD 共享声明 |
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| 责任方 | Bernadette Nedelec，Centre hospitalier de l'Université de Montréal (CHUM) | ||
| 研究赞助商 ICMJE | Centre hospitalier de l'Université de Montréal (CHUM) | ||
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| PRS 账户 | Centre hospitalier de l'Université de Montréal (CHUM) | ||
| 验证日期 | October 2018 | ||
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ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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