Comparing the Effects of Three Different Dressings on the Cutaneous Response of Sacral Skin
NCT ID: NCT03815240
Last Updated: 2020-05-06
Study Results
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View full resultsBasic Information
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COMPLETED
NA
12 participants
INTERVENTIONAL
2019-02-08
2019-07-23
Brief Summary
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The overall aim of this study is to measure the effects of Mepilex® Border Sacrum Dressing on the skin structure and function during mechanical loading compared to (1) no dressing, (2) ALLEVYN Life Sacrum Dressing and (3) Optifoam® Gentle Liquitrap Sacrum Dressing.
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Detailed Description
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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 intensities and to measure PU preventive device performance. Recently it could be shown that there are associations between structural and functional skin changes at the sacral area during loading. The overall aim of this study is to measure the effects of Mepilex® Border Sacrum Dressing on the skin structure and function during mechanical loading compared to no dressing, ALLEVYN Life Sacrum and Optifoam® Gentle Liquitrap Sacrum.
The procedure of one visit will be as follows:
After a skin acclimatization time of 30 minutes baseline measurements and Cyanoacrylate Skin Surface (CSSS)-stripping will be performed. Then a randomization envelope will be opened and the corresponding dressing will be applied or the skin will be left uncovered. The subject will then lie in supine position on a standard hospital mattress for a loading period of 3.5 hours. Every 30 minutes the head of the bed will be elevated to 45° for five minutes. During these five minutes, the participants will be instructed to bend their knees and to drag the feet repeatedly forth and back 10 times in order to simulate shear forces. The whole exercise will be done six times, after 0.5, 1, 1.5, 2, 2.5 and 3 hours. After 3.5 hours loading time in supine position the subjects will move into prone position. The dressing (if present) will be removed and all skin measurements and CSSS-stripping will be conducted again. The subjects will come back for another three times completing the remaining interventions. At the end, each volunteer will have received all three types of dressings once and once no dressing. In between, there are at least 3 weeks to prevent possible carry over effects.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
NONE
Study Groups
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no dressing (A)
No dressing will be applied at sacrum before 3.5 hours loading period in supine position
No dressing
no dressing at sacrum
Mepilex (B)
'Mepilex® Border Sacrum' dressing will be applied at sacrum before 3.5 hours loading period in supine position
Mepilex® Border Sacrum
adhesive sacrum dressing
Allevyn (C)
'ALLEVYN Life Sacrum' dressing will be applied at sacrum before 3.5 hours loading period in supine position
ALLEVYN Life Sacrum
adhesive sacrum dressing
Optifaom (D)
'Optifoam® Gentle Sacrum' Dressing will be applied at sacrum before 3.5 hours loading period in supine position
Optifoam® Gentle Sacrum
adhesive sacrum dressing
Interventions
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No dressing
no dressing at sacrum
Mepilex® Border Sacrum
adhesive sacrum dressing
ALLEVYN Life Sacrum
adhesive sacrum dressing
Optifoam® Gentle Sacrum
adhesive sacrum dressing
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
65 Years
80 Years
FEMALE
Yes
Sponsors
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Charite University, Berlin, Germany
OTHER
Responsible Party
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PD Dr. Jan Kottner
Principal Investigator
Locations
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Charité-Universitätsmedizin Berlin
Berlin, , Germany
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CRC-SP-A-32
Identifier Type: -
Identifier Source: org_study_id
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