Ostomy
Conditions
Brief summary
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.
Interventions
DEVICEVIPER
Comparison of ostomy systems
DEVICEEsteem™ Cut to Fit One Piece Closed End Pouch
Comparison of ostomy systems
Sponsors
ConvaTec Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female between 18 and 70 years of age (inclusive) at the time of randomization * Willing and able to provide written informed consent and HIPAA Waiver * An appropriate candidate for participation with unbroken non-irritated abdominal skin * Willing to adhere to the study procedures and to attend the scheduled study visits according to the requirements of the study protocol * Willing to adhere to the scheduled study visits * Good manual dexterity and be able to take care of their abdominal area independently * Be willing and able to record the required study data in a specified format
Exclusion criteria
* A history of a known sensitivity or allergy to System 3+ adhesive (modified Stomahesive® technology), Stomahesive®, Durahesive®, Polyethylene Film, or polyester fiber,or to any adhesive components in general as listed in the Investigators Brochure. * Subjects who have any other medical condition which, according to the investigator justifies exclusion from the study * Subjects with any chronic allergies requiring the use of prescription medication * History of skin disease affecting abdominal area * Currently uses topical ointments in the area of the abdomen or is unwilling/unable to terminate over the counter use of topical ointments in the area of the abdomen * Active case of eczema, dermatitis, psoriasis * Pregnant or lactating females. * Subject currently enrolled in another investigational study * Possesses extensive knowledge about either product (ie employees that re members or extended members of the Core Team work in ostomy research and development, or ostomy division sales and marketing )
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety: Related Events | 17 hours | All adverse events (AE's) related to the use of the device |
| Efficacy: Device Fall-Offs | 17 hours | The number and percentage of subjects with study device fall-off during the study |
| Safety: Skin Reactions | 17 hours | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adhesive | 1 hour | Initial tack of the adhesive (during first hour of wear) |
| Ease of Removal | 17 hours | Ease of removal of the adhesive wafer from the skin |
| Security | 17 hours | Perceived security of the study pouch during wear |
Countries
United States
Outcome results
None listed