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 (3M™ Cavilon™ Advanced High Endurance Skin Protectant) for the treatment of incontinence associated dermatitis.
Who can participate
Age range
1 Hour
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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?
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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?
. 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?