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

IMD Tech

Status

Unknown

Conditions

General Surgery

Oral Dryness

Treatments

Device: wetting lips following surgery using anesthesia

Study type

Interventional

Funder types

Industry

Identifiers

NCT00945022

WL - 01

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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