The primary objective of the study is to assess the safety and adhesive performance of the VIPER System when compared to the Esteem™ Cut to Fit One Piece Closed End Pouch when used by healthy volunteers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Comparison of ostomy systems
Comparison of ostomy systems
Susan Bell, RN, MSN, CWOCN
Jobstown, New Jersey, United States
Safety: Related Events
All adverse events (AE's) related to the use of the device
Time frame: 17 hours
Efficacy: Device Fall-Offs
The number and percentage of subjects with study device fall-off during the study
Time frame: 17 hours
Efficacy: Device Fall-Offs
The total number of study device fall-offs during the course of the study
Time frame: 17 hours
Safety: Skin Reactions
Time frame: 17 hours
Adhesive
Initial tack of the adhesive (during first hour of wear)
Time frame: 1 hour
Ease of Removal
Ease of removal of the adhesive wafer from the skin
Time frame: 17 hours
Security
Perceived security of the study pouch during wear
Time frame: 17 hours
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