Clinical Functional Assessment of Moisture Sensor on Wound Dressing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Number of Dressing Changes With Sensor Activation at Correct Timing
研究概览
简要总结
Explorative study of function of a moisture sensor on top of a superabsorbent wound dressing on exuding leg ulcers.
详细描述
The function of a novel moisture sensor placed on a superabsorbent wound dressing has been evaluated in a small clinical investigation. Five patients with leg ulcers were included. The investigational device, Absorbest Fuktsensor, was placed on the dressing DryMax Extra Soft. Two variants of the study product were used, Variant A and Variant B. The difference between the variants were that Variant B had an extra layer of a nonwoven between the moisture sensor and the dressing in an attempt to delay the activation of the moisture sensor a little compared to Variant A which was not equipped with this nonwoven layer.
The overall aim was to observe the function of the sensor in clinical use and practical operation. Further the aim was to evaluate the two combinations of Absorbest Fuktsensor and DryMax Extra Soft and decide which combination would activate the sensor display in a satisfactory way related to the utilization of the dressings absorbing capacity while avoiding leakage and maceration.
The study was performed accordingly to ISO 14155 and the declaration of Helsinki.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- 否
入选标准
- •Presence of moderate to highly exuding leg ulcer by clinician assessment
- •Wound deemed suitable for treatment with study product
- •Informed consent from the participants.
排除标准
- •Pregnancy
- •Bleeding from the wound
- •Known allergy to components
- •Wound infection
- •Mental illness
- •Illness or treatment of an indication other than the wound and which, according to the study personnel, can affect the wound treatment, the study and/or the dressing.
研究组 & 干预措施
A-B-A
Investigational device is Absorbest moisture sensor in variant A and variant B, placed on the backside of the wound dressing DryMax Extra Soft. Participants performed three dressing changes. They first received variant A, at next dressing change they received variant B, and on the third dressing change they received variant A again. No washout periods.
干预措施: Sensor activation (on DryMax Extra Soft) (Device)
B-A-B
Investigational device is Absorbest moisture sensor in variant A and variant B, placed on the backside of the wound dressing DryMax Extra Soft. Participants performed three dressing changes. They first received variant B, at next dressing change they received variant A, and on the third dressing change they received variant B again. No washout periods.
干预措施: Sensor activation (on DryMax Extra Soft) (Device)
结局指标
主要结局
Number of Dressing Changes With Sensor Activation at Correct Timing
时间窗: Inclusion visit to study completed after 3 dressing changes, 1-2 weeks
Sensor activation - measured as indication on the sensor display; indication at correct time, indication but not att correct time, no indication.
Timing of Dressing Change Related to Dressing Size and Weight After Use
时间窗: Inclusion visit to study completed after 3 dressing changes, 1-2 weeks
Dressing weight after use were measured on a scale and recorded. The weight were compared to a predefined table. Dressing size 10x10 cm: Changed too early \<11 g Correct change 11-26 g Changed too late \>26 g Dressing size 10x20 cm: Changed too early \<17 g Correct change 17-62 g Changed too late \>62 g Dressing size 20x20 cm: Changed too early \<26 g Correct change 26-109 g Changed too late \>109 g
次要结局
- Wound Size After Three Dressing Changes(At final dressing change no.3 (after 1-2 weeks))
- Level of Usability(Inclusion visit to study completed after 3 dressing changes, 1-2 weeks)
- Complications if the Dressing Was Switched Too Late.(Inclusion visit to study completed after 3 dressing changes, 1-2 weeks)
研究者
Fredrik Iredahl
MD, PhD.
Vårdcentralen Åby