Prospective, Multicenter, Observational Study to Evaluate the Clinical Performance of a Sterile, Bacteria-binding, Super-absorbent Wound Dressing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Number of patients with persisting infections will be documented in a standardized Case Report Form (CRF).
研究概览
简要总结
This prospective, multicenter, single-arm observational study aims to document the clinical performance and safety of a sterile, bacteria-binding, super-absorbent wound dressing for the intended use in a daily clinical practice. 50 patients (male/female) with superficial wounds of any etiology affecting only epidermis and dermis layer, with one or more clinical signs of infection or at high risk of infection and also high to very high exudate levels will be observed over a period of 14 days.
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
- •Men and women ≥ 18 years old
- •Written informed consent after patient education to participate in the study
- •Superficial wounds of any etiology affecting only epidermis and dermis layers
- •Maximum wound size: 6 x 16cm / 6 x 6cm
- •Wounds with one or more clinical signs or infection or assessed as at high risk of infection according to the following:
- •Wounds assessed as critically colonized with malodour, abnormal tissue or absence of viable tissue, excessive or increased serous exudate, possible extension of wound dimensions and no sign of a healing process and/or
- •Wounds with one or more historical episodes of topical infection and/or
- •Wounds assessed as at a high risk of infection on other grounds by the investigator.
- •Superficial wounds with high levels of exudate
排除标准
- •Not willing to sign or incapable of signing an informed consent form
- •Known allergy or sensitivity to one of the dressing components
- •Pregnancy or lactation
- •Subject is participating in another clinical study
结局指标
主要结局
Number of patients with persisting infections will be documented in a standardized Case Report Form (CRF).
时间窗: 14 days
Symptoms such as odor, pain, localized heat and erythema will be assessed by a clinician and documented in four different categories depending on its severity.
Number of participants with newly developed infections will be documented in a standardized Case Report Form (CRF)
时间窗: 14 days
Symptoms such as odor, pain, localized heat and erythema will be assessed by a clinician and documented in four different categories depending on its severity.
次要结局
未报告次要终点