Evaluation of Safety and Efficacy of Using Lipsus Device for Oral Wetting

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of Safety and Efficacy of Using Lipsus Device for Oral Wetting

Conditions
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Oral Dryness, General Surgery

Intervention / Treatment
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* Device: wetting lips following surgery using anesthesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lipsus<br> | Device: wetting lips following surgery using anesthesia<br>* The investigator will position the Lipsus device in accordance with the instructions for use<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). |  | 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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General Surgery