The purpose of this feasibility study is to evaluate the performance and skin-friendliness of the barrier of the Fecal Incontinence Management System. The investigator will complete a questionnaire for each of the tested products and the products will be evaluated as regards leakage, wear time, and skin-friendliness.
The purpose of this feasibility study is to evaluate the performance and skin-friendliness of the barrier of the Fecal Incontinence Management System. The investigator will complete a questionnaire for each of the tested products and the products will be evaluated as regards leakage, wear time, and skin-friendliness
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
4
The device is intended to remedy fecal incontinence.
Beth Israel Deaconess Medical Center, Inc.
Boston, Massachusetts, United States
The Primary Outcome Measure is Device Wear Time (Time From the Device is Applied Until it is Removed)
Time frame: 5 days
Is the Barrier Size and Shape Satisfactory
Percentage of subjects who answered yes to the question: is the barrier size and shape satisfactory
Time frame: Subjects were followed for the duration of the study, an average of 23 hours
Assessment of Skin 0-2 Inches From the Edge of the Anus
Skin condition scale: 1 = Normal skin without redness, 2 = Normal redness and intact skin, 3 = Abnormal redness but intact skin, 4 = Red and spotted but intact skin, 5 = Red and broken skin, 6 = Broken and bleeding skin Best skin condition score is 1, and worst skin condition score is 6.
Time frame: Subjects were evaluated before and after test
What is Your Assessment of the Ease of Correct Application of the Anal Adhesive?
Time frame: After application of product
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