N/A
N=12
Comparing the Effects of Three Different Dressings on the Cutaneous Response of Sacral Skin
Pressure Ulcer Prevention
Bottom Line
View on ClinicalTrials.gov: NCT03815240 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
May 2020
Primary outcome: Primary: Change in Skin Surface Temperature From Baseline — 3.1; 3.8; 3.0; 3.3 °C
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- No dressing (Other); Mepilex® Border Sacrum (Other); ALLEVYN Life Sacrum (Other); Optifoam® Gentle Sacrum (Other)
- Age
- Older Adult · 65+ yrs
- Sex
- Female
- Sponsor
- Charite University, Berlin, Germany
- Primary completion
- Jul 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Skin Surface Temperature From Baseline |
3.1; 3.8; 3.0; 3.3 | — |
| PRIMARY Change in Stratum Corneum Hydration (SCH) From Baseline |
7.0; 4.4; 5.9; 7.3 | — |
| PRIMARY Change in Erythema Index (EI) From Baseline |
29; 7; 41; 4 | — |
| PRIMARY Change in Average Roughness (Rz) From Baseline |
-0.8; -1; -0.8; -6.3 | — |
| PRIMARY Change in Arithmetic Average Roughness (Ra) From Baseline |
-0.8; -0.3; 0.5; -4.5 | — |
| PRIMARY Change in Maximum Roughness (Rmax) From Baseline |
-0.5; -1.8; -1.3; -8.0 | — |
| PRIMARY Change in Interleukin IL-1alpha Concentration From Baseline |
1.1; -0.1; 1.3; 1.3 | — |
| SECONDARY Occurence of Sacral Pain |
0; 0; 0; 0 | — |
| SECONDARY Time Until First Reporting of Sacral Pain |
NA; NA; NA; NA | — |
| SECONDARY Change in Erythema Score From Baseline |
9; 6; 5; 5; 3; 6 | — |
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 intensities and to measure PU preventive device performance.
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.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03815240). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.