Clinical Study to Assess a New Barrier Film's Ability to Provide Skin Protection Against Incontin… (NCT02570139) | Clinical Trial Compass
TerminatedNot Applicable
Clinical Study to Assess a New Barrier Film's Ability to Provide Skin Protection Against Incontinence & Allow Healing
Stopped: Low enrollment, short stay; lacked statistically powered evaluation for efficacy.
United States45 participantsStarted 2015-10
Plain-language summary
The purpose of the study is to evaluate the safety and efficacy of the investigational product (3Mâ„¢ Cavilonâ„¢ Advanced High Endurance Skin Protectant) for the treatment of incontinence associated dermatitis.
Who can participate
Age range1 Hour
SexALL
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Inclusion criteria
✓. Is the subject a full-term newborn (36 weeks or greater gestational age) or older?
✓. Is the subject in a facility providing nursing care 24 hours per day?
✓. Does the subject have severe Category 2 Incontinence-Associated Dermatitis (IAD) -red with skin breakdown (i.e. skin erosion and denudation or denudation of skin alone)?
✓. Is the subject willing to have photos taken of their skin exposed to incontinence and permit use of photographs in potential publication?
✓. Is the subject willing to release rights to 3M for the use of the photos?
✓. Is there a reasonable expectation that the subject will remain in a facility for at least 7 days following enrollment in the study?
✓. Has the subject, or their legally authorized representative, signed an Institutional Review Board-approved informed consent/assent document and authorized the use and disclosure of protected health information?
Exclusion criteria
✕. If female, is the subject pregnant or breast feeding or has she given birth within the 3 weeks preceding the screening visit?
✕. Does the subject have a known allergy to acrylates or cyanoacrylates?
✕. Does the subject have a Stage III, IV, unstageable, suspected deep tissue injury pressure ulcer in the area where the skin is affected by incontinence?
✕
What they're measuring
1
Percent Change From Baseline to End of Study in Incontinence Associated Dermatitis (IAD) Scores
Timeframe: up to 21 days depending on length of hospitalization