NCT05347927已完成不适用
Exploratory, Prospective, Multicenter, Observational Study to Evaluate the Influence of Undercast Material Types on Skin Microbiome
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 3
- 主要终点
- products´ influence on skin microbiome during fracture management
研究概览
简要总结
This clinical study will evaluate the clinical performance and the safety of the CE-marked casting and padding materials when used in routine fracture care without any additional invasive methods and within the intended use. As primary objective the cast therapy´s influence on skin microbiome during fracture management will be investigated. Further, the influence of the padding material on the skin microbiome, device comfort, skin conditions, and impact on daily life activities as well as HCP´s and patient´s satisfaction and general product safety and performance are considered as secondary outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Subject ≥ 18 years of age
- •Patient is physically and mentally able to participate in this study
- •Proper understanding of the Dutch language
- •Signed informed consent
- •Fractures to be treated with a short-arm cast without thumb inclusion for the period of 3 weeks (e.g. 2R3A1 = radial styloid avulsion, 2R3A2 = Simple radial fracture, 2U3A1 = Ulnar fracture of the base of the styloid process, 2U3A2= Simple distal ulna fracture, 2R3B1 = Intraarticular fracture of the styloid process of the radius (not displaced) or Triquetrum fracture (non AO classified))
排除标准
- •Subject <18 years of age
- •Pregnancy, breast feeding
- •Participation in other clinical trials
- •Patient is neither physically nor mentally able to participate in this study
- •Non-intact skin in treatment area (including dermatological issues)
- •Patients with impaired (e.g. Cortisone skin, extremely dry skin, parchment skin) or damaged skin with either a surgical wound or a traumatic wound
- •Medical treatment prior casting which could influence the microbiome
- •Known Blood Circulatory Diseases
- •Known Lymphedema or any general disorder of the lymphatic system
- •Known Osteoporosis
- •Known Diabetes
- •Knowing of one of the following illnesses that might require regular systemic medication: cancer, rheumatic disease
- •Intolerability or documented allergies against cast materials
- •Subjects with not "normal" (unusual) hygienic behavior
- •Suspected drug addiction or alcohol abuse
- •Patients diagnosed HIV-positive or with infectious hepatitis based on self-declaration by subjects
结局指标
主要结局
products´ influence on skin microbiome during fracture management
时间窗: 3 weeks
Beta diversity skin microbiome
次要结局
- Treatment comfort(3 weeks)
- Number of adverse events during study per product(3 weeks)
- General product performance(3 weeks)
- Impact on daily life activities(3 weeks)
研究者
研究点 (3)
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