NCT03271164已完成不适用
Prospective Randomized Controlled Case Series Evaluating the Safety and Efficacy of FBPM10 System When Compared to Standard of Care in the Treatment of Post-surgical Wounds
KLOX Technologies Inc.2 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2017年8月29日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Adverse events, Serious adverse events, device incidents and compliance
研究概览
简要总结
This is a prospective randomized controlled case series in patients having a surgery for bilateral breast reduction. Objectives of the case series are to evaluate the safety and efficacy of the FBPM10 System when compared with standard of care (massages with vitamin E cream) in the treatment of post-surgical wounds.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed and dated written informed consent form;
- •Female 18 years of age and older;
- •Good general health, stable weight, free of systemic diseases such as diabetes, arthritis, HIV infection or genetic disorder that could influence the outcome of the treatment;
- •Fitzpatrick skin type I to III;
- •Patients with bilateral breast reduction, expected to have newly formed post-surgery breast incisions of comparable length and of comparable appearance, located on comparable skin area;
- •Patients able to understand, willing and able to comply with all study requirements and post-operative instructions.
排除标准
- •Inability to understand the Study and its requirements or to give informed consent;
- •Systemic antibiotic therapy or anti-inflammatory drugs or any other medication(s) that might interfere with healing within the last three months prior to Treatment initiation;
- •Current use of anticoagulants such as (but not limited to) warfarin, clopidogrel, enoxaparin or high doses of aspirin (> 162 mg daily);
- •Female pregnant patient (by medical history or as ascertained by a pregnancy test);
- •Patient with current alcohol use or actively consuming drugs (addiction) as it may interfere with patient's ability to comply with Study procedures;
- •Patient with known photosensitivity, taking drug(s) to treat photosensitivity, with concurrent disease (such as porphyria) or drug(s) (such as methotrexate or chloroquine) known to induce severe photosensitivity of the skin;
- •Patients who are immunocompromised or taking immunosuppressive therapy;
- •Any concurrent therapy that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the Study investigational device;
- •Patient has ongoing malignant disease of any type, active systemic, local skin infection or disease, autoimmune disease or any significant chronic disease which, in the opinion of the investigator, might interfere with the evaluation of the Study objectives or would result in non-compliance with the Study protocol;
- •Patients having had surgery in the area to be incised within one year of Study Screening;
- •Patients with tattoos in the areas of incisions;
- •Patients with history or familial history of keloids or hypertrophic scars;
- •Patients with incisions that are actively bleeding;
- •Patients with known skin hypersensitivity;
- •Patients with known allergic reactions to silicone.
- •Patients that cannot start the treatment within 14 days of the surgery.
研究组 & 干预措施
Treatment with FBPM10 system
Experimental
One breast will be randomized to be treated with FBPM10 System.
干预措施: FBPM10 System (Device)
Treatment with standard of care
Active Comparator
One breast will be selected to be treated with massages with vitamin E cream.
干预措施: Massages with vitamin E cream (Other)
结局指标
主要结局
Adverse events, Serious adverse events, device incidents and compliance
时间窗: Up to 24 weeks
Number of adverse events, serious adverse events, device incidents and missed treatment visits
次要结局
- Vancouver Scar Scale (VSS)(Up to 24 weeks)
- Patient and Observer Scar Assessment Scale (POSAS)(Up to 24 weeks)
- Ease of wound management(Up to 24 weeks)
研究者
研究点 (2)
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