Status:
COMPLETED
Comparing the Effects of Three Different Dressings on the Cutaneous Response of Sacral Skin
Lead Sponsor:
Charite University, Berlin, Germany
Conditions:
Pressure Ulcer Prevention
Eligibility:
FEMALE
65-80 years
Phase:
NA
Brief Summary
Skin functional parameters such as erythema or stratum corneum hydration have been successfully used in PU prevention research. These parameters are able to discriminate effects of different loading i...
Detailed Description
Pressure ulcers (PUs) are severe and unwanted cutaneous lesions and subcutaneous wounds caused by prolonged skin and underlying soft tissue deformation. In the supine position they predominantly occur...
Eligibility Criteria
Inclusion
- Healthy female volunteers
- 65 to 80 years
- Body Mass Index 18.5 to 29.9 kg/m2
- Non-smoker of at least one year (including electronic-cigarettes)
- Informed consent
- Being free of any clinical dermatosis in the investigational area
- Intact sacral skin without scars
- Skin phototype I, II, or III (according to Fitzpatrick)
- No regular use of leave-on products on the sacral skin
- Willing and able to fulfil the study requirements
Exclusion
- Disability to maintain in supine or prone Position
- Acute diseases
- Known hyper-sensibility or allergy to the study product or any of its ingredients
- Extensive UV exposure 4 weeks before study inclusion
- Use of topical treatment on the investigational areas or systemic Treatment within the 4 past weeks (topical hyaluronan, anti-inflammatory drugs, corticoids, retinoids, NSIDS etc.) that would interfere with assessment and/or investigational treatments
- Medical history of skin cancer
- History of established Diabetes mellitus, cardiac or renal insufficiency, COPD
- Chronic inflammatory skin disorders such as atopic dermatitis, psoriasis, lichen planus
- Participation in another study 4 weeks prior to study start
Key Trial Info
Start Date :
February 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 23 2019
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03815240
Start Date
February 8 2019
End Date
July 23 2019
Last Update
May 6 2020
Active Locations (1)
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1
Charité-Universitätsmedizin Berlin
Berlin, Germany, 10117