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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2012-04-30

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.

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Detailed Description

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Conditions

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Oral Dryness General Surgery

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Lipsus

Group Type EXPERIMENTAL

wetting lips following surgery using anesthesia

Intervention Type DEVICE

The investigator will position the Lipsus device in accordance with the instructions for use

Interventions

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wetting lips following surgery using anesthesia

The investigator will position the Lipsus device in accordance with the instructions for use

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No