Status:
TERMINATED
Comparative Study to Assess an Advanced Skin Protectant in the Management of Incontinence-associated Dermatitis
Lead Sponsor:
Solventum US LLC
Collaborating Sponsors:
3M
Conditions:
Incontinence-associated Dermatitis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 Dermatiti...
Detailed Description
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 dermatiti...
Eligibility Criteria
Inclusion
- 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
- 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?
- 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?
Key Trial Info
Start Date :
November 17 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 10 2018
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03298113
Start Date
November 17 2017
End Date
July 10 2018
Last Update
December 2 2024
Active Locations (3)
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1
Universitair Ziekenhuis Gent
Ghent, East Flanders, Belgium, 9000
2
Charité - Universitätsmedizin Berlin
Berlin, Germany, 10117
3
University Hospital Southampton
Southampton, United Kingdom, SO16 6YD