CompletedNot Applicable

A Clinical Evaluation of 3M Cavilon Advanced Barrier Film for the Treatment of Incontinence Associated Dermatitis (IAD)

16 participantsStarted 2014-08

Plain-language summary

The purpose of this study is to obtain information concerning the safety and effective use of a protective barrier film in patients experiencing severe incontinence associated dermatitis.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Is the subject 18 years of age or older?
✓. Is the subject in a facility providing nursing care 24h per day?
✓. Does the subject have severe incontinence-associated dermatitis eg breached or denuded skin? The ideal candidate would have denudement present.
✓. Is the subject willing to have photos taken of their skin exposed to incontinence and permit use of the photos in potential publications?
✓. Is the subject willing to release rights to 3M for use of the photos?
✓. Has the subject signed an Institutional Review Board-approved informed consent document and authorized the use and disclosure of protected health information? At NS-LIJ, only subjects who are capable of consenting are eligible to enroll. The study will not include participants with decisional impairment that would render them incapable of informed consent.

Exclusion criteria

✕. If female, is the subject pregnant or breast feeding or have they given birth within the 3 weeks preceding the screening visit?
✕. Does the subject have a known allergy to acrylates or cyanoacrylate?
✕. Does the subject have a current pressure ulcer in the area where the skin is affected by incontinence?
✕. Does the subject have an active genital herpes infection?
✕. Does the subject have a pre-existing abnormal skin disease on the treatment areas that may affect skin assessment?
✕. Does the skin area involved in this study require treatment with a concomitant medication or product?
✕. Has the subject been enrolled in any investigational study within 30 days of the Screening Visit?
✕. Does the subject have any medical condition that in the opinion of the investigator should exclude him/her from participating in the study?

What they're measuring

Number of Participants With Change in Incontinence Associated Dermatitis Score

Timeframe: Baseline and end of treatment (up to 3 weeks)

Trial details

NCT IDNCT02724449

SponsorSolventum US LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-02

Results submitted2017-03-13

View on ClinicalTrials.gov More Dermatitis trials