NCT04771819已完成不适用
Safety and Performance of SoftOx Wound Irrigation Solution (SWIS) Compared to Normal Saline (NS) in Human Experimental Suction Blister Wounds
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Degree (percentage) re-epithelialization in the suction blister wound on day 10 in the SWIS treated wound versus NS treated wound
研究概览
简要总结
This is an open, evaluator blinded, intra-comparative, randomized, non-inferiority investigation prior to CE mark to confirm safety and performance of the SWIS device when used as intended, i.e. as an irrigation solution for mechanical rinsing of breached or compromised skin as a result from acute wounds.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy and intact skin where the blister suction wounds will be induced
- •Been informed of the nature, the scope and the relevance of the clinical investigation
- •Voluntarily agreed to participation and has duly signed the Information Consent Form
排除标准
- •Participating in any other clinical investigation
- •Disease that may interfere with the wound healing, e.g. diabetes, arterial-, renal-, liver, or cardiac insufficiency, chronic obstructive lung disease, cancer, autoimmune disease, edema of the arm, severe obesity, severe psychiatric disease, dementia or previous known wound healing problems, as judged by the investigator
- •Active skin disease, e.g. dermatitis, psoriasis and wounds, and/or tattoos in the areas where suction blister wounds will be induced, as judged by the investigator
- •Daily smoker
- •Systemic immunosuppressive treatment
- •Uncontrolled pain that may interfere with the investigation outcome, as judged by the investigator
- •Allergy to hypochlorous acid, acetic acid or any other remedies/material used in the clinical investigation
- •Not able to read or understand Danish
- •Any other conditions that as judged by the investigator may make follow-up or investigation inappropriate
- •That according to the Declaration of Helsinki is deemed unsuitable for study enrolment
研究组 & 干预措施
SoftOx Wound Irrigation Solution (SWIS)
Experimental
Blister wounds will be irrigated and soaked for 15 minutes.
干预措施: SWIS (Device)
Normal Saline
Active Comparator
Blister wounds will be irrigated and soaked for 15 minutes.
干预措施: SWIS (Device)
结局指标
主要结局
Degree (percentage) re-epithelialization in the suction blister wound on day 10 in the SWIS treated wound versus NS treated wound
时间窗: From baseline to day 10
Measure the degree of re-epithelialization to evaluate any differences between the treatments.
次要结局
- The incidence and severity of adverse events(Baseline to day 17)
- Percentage of suction blister wounds healed on day 10 in the SWIS treated wound versus NS treated wound(Day 10)
- Percentage of suction blister wounds with >30% CFU reduction in the SWIS treated wound and NS treated wound respectively if positive CFU level prior irrigation(Day 4)
- Percentage of suction blister wounds healed on day 17 (+/- 1 day) in the SWIS treated wound versus NS treated wound(Day 17)
- Subject evaluation of pain during each irrigation procedure on days 0, 2 and 4 in the SWIS treated wound versus NS treated wound(Baseline (day 0), day 2 and day 4)
- Degree (percentage) re-epithelialization in the suction blister wound on day 4 in the SWIS treated wound versus NS treated wound.(From baseline to day 4)
研究者
研究点 (1)
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