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

Not Applicable

• Conditions: Oral Dryness; General Surgery
• Interventions: Device: wetting lips following surgery using anesthesia

• Registration Number: NCT00945022
• Lead Sponsor: IMD Tech Ltd

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2009-07
• Study First Submitted: 2009-07-13
• Study First Submitted QC: 2009-07-22
• Study First Posted: 2009-07-23
• Last Update Submitted: 2011-06-08
• Last Update Posted: 2011-06-09
• Study Start: 2011-10
• Primary Completion: 2012-02
• Study Completion: 2012-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lipsus	wetting lips following surgery using anesthesia	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Shaari Zedek Medical Center; 🇮🇱 Jerusalem, Israel