A Clinical Evaluation of 3M Cavilon Advanced Barrier Film for the Treatment of Incontinence Associated Dermatitis (IAD)
NCT ID: NCT02724449
Last Updated: 2024-12-17
Study Results
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View full resultsBasic Information
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COMPLETED
NA
16 participants
INTERVENTIONAL
2014-08-31
2015-02-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Cavilon Advanced Barrier Film
Cavilon Advanced Barrier Film applied to areas of IAD
Cavilon Advanced Barrier Film
Cavilon Advanced Barrier Fim's application applied twice a week
Interventions
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Cavilon Advanced Barrier Film
Cavilon Advanced Barrier Fim's application applied twice a week
Eligibility Criteria
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Inclusion Criteria
2. Is the subject in a facility providing nursing care 24h per day?
3. Does the subject have severe incontinence-associated dermatitis eg breached or denuded skin? The ideal candidate would have denudement present.
4. Is the subject willing to have photos taken of their skin exposed to incontinence and permit use of the photos in potential publications?
5. Is the subject willing to release rights to 3M for use of the photos?
6. 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.
18 years or older
Exclusion Criteria
1. If female, is the subject pregnant or breast feeding or have they given birth within the 3 weeks preceding the screening visit?
2. Does the subject have a known allergy to acrylates or cyanoacrylate?
3. Does the subject have a current pressure ulcer in the area where the skin is affected by incontinence?
4. Does the subject have an active genital herpes infection?
5. Does the subject have a pre-existing abnormal skin disease on the treatment areas that may affect skin assessment?
6. Does the skin area involved in this study require treatment with a concomitant medication or product?
7. Has the subject been enrolled in any investigational study within 30 days of the Screening Visit?
8. Does the subject have any medical condition that in the opinion of the investigator should exclude him/her from participating in the study?
9. Has the subject received antifungal powders within 24 hours prior to enrollment?
10. Has the subject received cyanoacrylate based skin protectant to the affected areas (such as Marathon) within 72 hours prior to enrollment?
11. Is the facility unwilling to discontinue use for this subject of Dimethicone containing wipes on the area where the investigational device will be applied?
12. Is the facility unwilling to discontinue use for this subject of Chlorhexidine Gluconate wipes on the area where the investigational device will be applied?
18 Years
ALL
Yes
Sponsors
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3M
INDUSTRY
Solventum US LLC
INDUSTRY
Responsible Party
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References
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Gray M, Beeckman D, Bliss DZ, Fader M, Logan S, Junkin J, Selekof J, Doughty D, Kurz P. Incontinence-associated dermatitis: a comprehensive review and update. J Wound Ostomy Continence Nurs. 2012 Jan-Feb;39(1):61-74. doi: 10.1097/WON.0b013e31823fe246.
Doughty D, Junkin J, Kurz P, Selekof J, Gray M, Fader M, Bliss DZ, Beeckman D, Logan S. Incontinence-associated dermatitis: consensus statements, evidence-based guidelines for prevention and treatment, and current challenges. J Wound Ostomy Continence Nurs. 2012 May-Jun;39(3):303-15; quiz 316-7. doi: 10.1097/WON.0b013e3182549118.
Beeckman D, Schoonhoven L, Verhaeghe S, Heyneman A, Defloor T. Prevention and treatment of incontinence-associated dermatitis: literature review. J Adv Nurs. 2009 Jun;65(6):1141-54. doi: 10.1111/j.1365-2648.2009.04986.x. Epub 2009 Apr 3.
Other Identifiers
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14-348
Identifier Type: -
Identifier Source: org_study_id