The LipSense Clinical Research
Subtitle could be a name or a date of publish
The LipSense Clinical Research was made during July 2012 by Dr. Alex Iskovich and Prof. Ari Zimran , Sharey Tzedek Hospital Medical Center, Jerusalem, Israel
Dr. Alex Iskovich, Prof. Ari Zimran , Sharey Tzedek Medical Center, Jerusalem, Israel
Registrated study : NCT00945022, WL – 01, Evaluation of Safety and Efficacy of using LIPSense Device for oral wetting
Objective: to assess safety and (preliminary) efficacy of the LIPSense device to alleviate the sensation of
Lip and oral dryness following general anesthesia
Methods: Patients who were candidates for surgery under general anesthesia were randomly approached in the pre-op clinic by one of the Investigators and offered the use of the LIPSense device post-op in the context of a clinical trial with this new system.
The device was shown to the patient and written Informed Consent was requested.
One of the Investigators awaited the patient in the PACU (Recovery Room) after surgery.
In the case of the patient complaining of lip and / or oral dryness, the nurse on-call in the PACU alerted the Investigator who would then ask the patient to score the degree of dryness discomfort on a 0-10 scale,
where zero indicated no discomfort and 10 represented a worst, very significant discomfort.
The Investigator would then set up the LIPSense device and mounted the moist applicator on the patient face.
A second record of the discomfort/dryness score has been taken approximately one hour after continuous use
of the LIPSense device and then a third rating after 2 hours or at discharge from the PACU whichever came first.
Results: Of the 15 randomly approached patients, one patient (6.7%) was not interested to participate in the study. Of the remaining 14 patients who all signed Informed Consent, there were 8 males: mean age was 58.5 years (range 21-77 years); and 6 females: mean age 58.3 years (range 43-78 years).
One of the patients underwent 2 surgeries under general anesthesia during the trial period.
After the first surgery, the patient did not complain of lip/oral dryness, however same patient did complain of dryness after the second surgery and used the LIPSense device after the second surgery. Of the remaining 13 patients, one patient was transferred directly from the Operating Theatre to the Intensive Care Unit.
Four other patients did not complain of lip/oral dryness post-op and therefore did not need to avail themselves of the LIPSense device.
In all 10 patients who used the LIPSense device due to complaints of lip/oral dryness after general anesthesia discomfort has been reported as fully resolved and eliminated as result of the use of the device.
One patient complained of mild dripping from the device onto her jaw and the device has been replaced by a new one to the satisfaction of the patient. During the 10 minutes between the removal of the first device and the new one, the patient applied a wetted tongue depressor and wet gauze pads.
Safety: There were no adverse events and no patient requested that the LIPSense device be removed.
Efficacy: No patient requested additional wetting of the lips while the LIPSense device was in place. All patients reported that the lip/oral dryness was completely relieved by the LIPSense device.
Additional Comments: The PACU staff was comfortable with the installation of the LIPSense system and was satisfied with its safety and efficacy.
Table of the study participants who were treated with the LIPSense device
|Age(YR)||Sex||Surgical procedure (under general anesthesia)||Baseline Discomfort score (0-10)||T1Discomfort score at 60min (0-10)||T2Discomfort score last score and time recorded(0-10)||Comments|
|1||56||M||Laparoscopic Cholecystectomy||9||0||0 @ 70’||significantly less oral dryness; easy to use|
|2||71||F||Laparoscopic Cholecystectomy||6-7||0||0 @ 65’||easy to use|
|3||54||F||Laparoscopic Gastropexy / Gastric bypass||7||0||0 @ 70’||nothing to report|
|4||62||M||Radical Prostatectomy||7||0||0 @ 120’||easy to use; hopes not to suffer from latent oral virus post-recovery as usually does|
|5||64||M||Closure of Colostomy||7||0||0 @ 80’||easy to use; completely eliminated sense of oral dryness|
|6||51||M||Nephrectomy||6||0||0 @ 120’||very satisfied with the set-up|
|7||60||M||Radical Prostatectomy||7||1-2||0@120’||nothing to report|
|8||44||F||Laparoscopic Colectomy||5||0||0@120’||patient with the mild dripping whose set-up was switched|
|9||21||M||Excision of Osteoma||8||0||0@70’||very satisfied with the set-up|
|10||77||M||Nissen fundoplication (correction of GastroEsophageal reflux)||8||initially complained of severe oral dryness, but then became confused and could not provide scores after 60’|