Clinical Study to Assess a New Barrier Film's Ability to Provide Skin Protection Against Incontinence & Allow Healing

Stopped early · Not applicable

Conditions studied: Incontinence Associated Dermatitis

In brief

The purpose of the study is to evaluate the safety and efficacy of the investigational product (3M™ Cavilon™ Advanced High Endurance Skin Protectant) for the treatment of incontinence associated dermatitis.

Key facts

Study ID

NCT02570139

Run by

Solventum US LLC

People needed

45

Starts

2015-10-01

Expected to finish

2017-06-23

Last updated by the study team

2024-10-02

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects may be enrolled into this study if the answers to all these questions are yes.
• 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?

You may not qualify if…

• Subjects are excluded from participation in this study if any of the answers to these following questions is yes.
• 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?
• Does the subject have a preexisting skin disease on the areas affected by incontinence that may make skin assessments for this study difficult?
• Does the skin area affected by incontinence require treatment with a concomitant medication or product?
• Does the subject have an active genital herpes infection?
• Has the subject received antifungal powders in the area affected with IAD within 24 hours prior to enrollment?
• Has the subject received cyanoacrylate based skin protectant (such as Marathon) within 72 hours prior to enrollment?
• Is the facility unwilling to discontinue use for this subject of Dimethicone-containing wipes on the area where the skin protectant product will be applied?
• Is the facility unwilling to discontinue use for this subject of Chlorhexidine Gluconate wipes on the area where the skin protectant product will be applied?
• Does the subject have any medical condition that in the opinion of the investigator should exclude him/her from participating in the study?
• Has the subject been enrolled in any investigational study where product was applied to proposed study sites within 30 days of the screening visit?

Where it is running

• Children's Hospitals and Clinic — Minneapolis, Minnesota, United States
• Children's Hospital and Clinics — Saint Paul, Minnesota, United States
• Good Samaritan — Kearney, Nebraska, United States
• St. Elizabeth — Lincoln, Nebraska, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• North Shore University Hospital — Manhasset, New York, United States
• Lennox Hill — New York, New York, United States
• St. John — Tulsa, Oklahoma, United States
• Roper St. Francis — Charleston, South Carolina, United States
• Baylor Plano — Plano, Texas, United States

Full record on ClinicalTrials.gov

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