The purpose of this study is to assess the safety (absence of skin irritation) of a feminine hygiene product for perineal hygiene prior to undertaking a clinical effectiveness trial. The feminine hygiene towel or wipe is an anti-bacterial Natural Health Product solution.
The design of the trial will be open-label and uncontrolled.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Each participant will be asked to complete a treatment period of one month's duration. At the start of the study, the participants will be asked to fill-out a baseline questionnaire and will be given a month's supply of the perineal hygiene towel with instructions about its use. At day 15, 30 and 45 follow-ups will be conducted.
Division of Geriatric Medicine, Clinical Sciences Building, University of Alberta Hosp
Edmonton, Alberta, Canada
Number of participants without any adverse events as a measure of safety
Number of participants without any adverse events
Time frame: 45 Days
Ease of use of the perineal hygiene wipe by the participants on a daily basis
Ease of use of the perineal hygiene wipe by the participants on a daily basis
Time frame: 30 Days
Self-reported comfort score on a scale of 1 to 10
Self-reported comfort score on a scale of 1 to 10
Time frame: 30 Days
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