Investigation of the Clinical Performance of Biatain Fiber Ag on Burns
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 9
- 主要终点
- Percentage of Wounds Healed Within 14 Days
研究概览
简要总结
The goal of this study is to test a new gelling fiber wound dressing with silver on patients with a partial thickness burn wound, which is infected or at risk of infection.
Participants will be asked to wear the test dressing in a two weeks period(+/- 2 days) consisting of 3-4 study visits, and will have the dressing changed once pr. week at the research facility. The wound will be cleaned, assessed and photos will be uploaded to a digital software system.
详细描述
The clinical investigation is a non-comparative, one-armed, open-labelled, multi-centre study.
The test product, Biatain Fiber Ag is a non-CE-marked gelling fiber wound dressing, containing silver. The product is intended for moist wound healing and exudate management of moderate to high exuding wounds. The product has a classification III, as it contains the active ingredient silver.
The overall purpose of this investigation is to obtain clinical data supporting effectiveness of Biatain Fiber Ag to obtain the CE-mark in EU.
The total study duration for the subject will be approximately two weeks (+/- 2 days), consisting of a two-week test period and 4 study visits (V0/V1, V2 and V3). V3 will also terminate the 2-week study period.
The primary endpoint is percentage of wounds healed within 14 days (≥ 95 % reepithelialisation) The clinical investigation will be conducted in a total of 50 eligible subjects with a partial thickness burn wound that are infected or at risk of infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has signed informed consent
- •Is between 18 -65 years (both included)
- •Is capable of following study procedure (assessed by investigator).
- •Has a partial thickness burn wound
- •Has a burn wound that is infected or at risk of infection (assessed by investigator)
- •The size of burn (including both study wound and non-study injuries) has a Total Body Surface Area (TBSA) less than 10% (assessed by investigator).
- •The wound should fit under a 20x30 cm dressing (600 cm2) or smaller
- •The shape and location of the wound should be suitable for photo capture (assessed by the investigator).
- •Has a wound that has medium to high level of exudate (assessed by the investigator)
- •Is suitable to use the test product for wound treatment (assessed by the investigator).
排除标准
- •Is pregnant/breastfeeding
- •Is currently receiving or has within the past 60 days received radio- and/or chemotherapy (low doses radio- and/or chemotherapy is allowed for other indications than cancer if assessed by investigator not to influence study wound area)
- •Known history of skin sensitivity to any components of the test dressings
- •>72 hours from time of injury
- •Intake of antibiotics within one week before the start of the enrolment
- •Use of chemical debridement
- •Participation in any other clinical studies that can compromise this study treatment (assessed by the investigator).
结局指标
主要结局
Percentage of Wounds Healed Within 14 Days
时间窗: 2 weeks
The percentage of wounds achieving healing within 14 days (+/- 2 days). A wound was considered healed if re-epithelialization was visually assessed to be 95% or greater.
次要结局
未报告次要终点