Comparative Study to Assess an Advanced Skin Protectant in the Management of Incontinence-associa… (NCT03298113) | Clinical Trial Compass
TerminatedNot Applicable
Comparative Study to Assess an Advanced Skin Protectant in the Management of Incontinence-associated Dermatitis
Stopped: slow enrollment
Belgium, Germany, United Kingdom20 participantsStarted 2017-11-17
Plain-language summary
The purpose of the clinical study is to assess the effects of 3M Cavilon Advanced Skin Protectant in comparison to different local IAD care regimes in hospitals (IAD: Incontinence-associated Dermatitis)
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Is the patient 18 years or older?
✓. Has the patient or their legally authorized representative signed the Informed Consent Form?
✓. Does the patient have IAD category 1A (IAD 1A: persistent redness without clinical signs of infection) or IAD category 2A (IAD 2A: skin loss without clinical signs of infection) in the study area (study area: the sacral region going down to the upper thighs, bordered approximately 5 cm below the gluteal fold?
✓. Is the patient incontinent and does stool and/or urine come into direct contact with the skin?
✓. Is the patient able to be turned/positioned with regard to skin assessment and photo documentation?
✓. Is there a reasonable expectation that the patient will remain in the hospital setting for at least 7 days?
Exclusion criteria
✕. Is the patient pregnant or breast feeding?
✕. Does the patient have a known hypersensitivity or allergy to acrylate or cyanoacrylate?
✕. Does the patient have a stage II, III, IV or unstageable pressure ulcer or other suspected deep tissue injury in the study area?
✕. Does the patient require topical treatment due to a fungal, bacterial or viral infection in the study area?
✕. Does the patient require treatment with topical medication or product other than IAD treatment in the study area?
What they're measuring
1
Healing of IAD
Timeframe: up to 21 days depending on length of hospitalization
✕. Does the patient have any other local dermatological disease or skin condition interfering with this study?
✕. Does the patient have any medical condition (e.g. end of life, planned elective surgery) that in the opinion of the investigator should exclude him/her from participating in the study?
✕. Does the patient participate in another study with a known or implied effect on skin barrier function?