NCT05422248招募中不适用
Oxygen Wound Therapy Feasibility Study
Fisher and Paykel Healthcare1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2022年12月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change in wound area
研究概览
简要总结
Determine the feasibility of using a new topical oxygen therapy device to treat hard to heal lower leg wounds.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with hard to heal lower leg wounds as determined by the treating clinician.
- •Patient has a wound area greater than the area of the interface
- •Aged 16 years and over
- •Able to provide informed consent
排除标准
- •Lower limb wounds with bone or tendon exposed
- •Infected wounds which require treatment with antibiotics
- •Wounds with critical bioburden requiring a medicated dressing
- •Wounds that require dressing changes more than every second day, for example high exudating wounds
- •Wounds with slough covering more than 30% of the wound surface
研究组 & 干预措施
Series
Active Comparator
Standard wound care for 4 weeks followed by intervention device wound care for up to 12 weeks.
干预措施: Series Topical Oxygen Therapy (Device)
Paired
Active Comparator
Intervention device wound care to a portion of wound and standard wound care to the remaining portion of the wound, for up to 12 weeks.
干预措施: Paired Topical Oxygen Therapy (Device)
结局指标
主要结局
Change in wound area
时间窗: 12 weeks
cm\^2
次要结局
未报告次要终点
研究者
研究点 (1)
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