Evaluation of Safety and Efficacy of Using Lipsus Device for Oral Wetting
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The safety of using the Lipsus device for oral wetting will be established by physician's assessment/observation of adverse events (signs of pain, allergies, infection or any adverse effect).
研究概览
简要总结
Following waking up from surgery performed under general anesthesia, patients are suffering from discomforting oral dryness, and moreover, they are not allowed drinking for 24 hours. The current management involves the wetting of patient's lips using wet bandage. This action is dependent on the presence of a family member or a nurse, which is not always possible. Many patients describe the oral dryness as a suffering, added to the suffering anyway entailed by surgery.
The investigated Lipsus device is intended for oral wetting, relieving patient's suffering and minimizing the dependence on continuous presence next to patient's bed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Subject is scheduled for surgery under general anesthesia.
- •Male/female age 18 and up.
- •Subject able to comprehend and give informed consent for participation in this study
- •Subject must sign the Informed Consent Form.
排除标准
- •Subjects who have any form of suspicious lesion in treatment target area.
- •Pregnant or lactating Subjects
- •Subjects with any infection / abscess / bleeding / blister / crack / edema / fissure / ulcer / pain in treatment target area.
- •Eczema or dermatitis in treatment target area
- •Subjects on drugs or psychologically determined unsuitable for the study.
- •Subject is suffering extreme general weakness.
- •Subject objects to the study protocol.
- •Concurrent participation in any other clinical study
- •Physician objection
结局指标
主要结局
The safety of using the Lipsus device for oral wetting will be established by physician's assessment/observation of adverse events (signs of pain, allergies, infection or any adverse effect).
时间窗: 2 days
次要结局
- The efficacy of using the Lipsus device for oral wetting will be established by Level of oral dryness improvement measured by VAS oral dryness questionnaire.(2 days)