Safety Assessment of Cold Gas Plasma on Intact Skin
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- pain
研究概览
简要总结
In this study the application of cold atmospheric plasma (CAP) will be tested on intact skin of volunteers. To test safety, several skin parameters will be monitored, the antimicrobial effect will be investigated as well. The investigators expect this treatment to have a good antimicrobial effect with acceptable, transient skin sensations.
详细描述
Control of infection and bacterial colonisation constitutes a continuing challenge in patients with burns. Prevention of microbial contamination and infection is vital for burn wound care as bacterial presence can result in excessive inflammatory reactions, delayed re-epithelialisation, impaired matrix remodelling and bacteraemia. A novel method to decrease the likelihood of infection and to help cure wounds is cold atmospheric plasma (CAP). CAP has been shown in vitro to kill a wide range of pathogenic bacteria.
This safety study aims to demonstrate the safety, efficacy and efficiency of CAP for burn wound treatment. Intact skin of volunteers will be CAP treated. Local skin reaction (blister formation, pain, itching), erythema, local skin temperature, trans epidermal water loss (TEWL) and reduction of the bacterial load wil be monitored.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- 是
入选标准
- •Able and willing to comply with the research protocol
- •No language barrier
排除标准
- •Atopic dermatitis or other skin disease
- •Implanted electrical medical devices such cardiac pacemakers
- •Pregnant or lactating women
- •Patients with infected wounds.
- •Life-threatening cardiac conductivity abnormality
- •Active malignancy
- •Women of childbearing age not using contraceptive measures
研究组 & 干预措施
CAP treated
volar arm will be treated with cold atmospheric plasma.
干预措施: Cold Atmospheric Plasma (Device)
CAP on bacteria
volar arm with bacteria will be treated with cold atmospheric plasma.
干预措施: Cold Atmospheric Plasma (Device)
no CAP on bacteria
volar arm with bacteria will not be treated with cold atmospheric plasma. Sham comparator for measurements of skin parameters TEWL, temperature and bacterial load.
结局指标
主要结局
pain
时间窗: before to 30 minutes after treatment
by using a visual analogue thermometer (VAT)
次要结局
- trans epidermal water loss(before to 30 minutes after treatment)
- local skin reaction(directly to 30 minutes after treatment)
- reduction of the bacterial load(directly to 5 minutes after treatment)
- local skin temperature(before to 30 minutes after treatment)
- colour/pigmentation(before to 30 minutes after treatment)