Comparing the Effects of Three Different Dressings on the Cutaneous Response of Sacral Skin

Study Overview
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Brief Summary
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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. 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.

Detailed Description
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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 near to bony prominences, like at the sacral area. The cornerstone of PU prevention is repositioning, early mobilization and the use of special support surfaces. In addition, empirical evidence suggests that the application of preventive dressings on PU predilection sites helps to prevent PU development. 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.

Official Title
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Comparing the Effects of Three Different Dressings on the Cutaneous Response to Pressure and Shear of Sacral Skin: an Exploratory Crossover Study

Conditions
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Pressure Ulcer Prevention

Intervention / Treatment
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* Other: No dressing
* Other: Mepilex® Border Sacrum
* Other: ALLEVYN Life Sacrum
* Other: Optifoam® Gentle Sacrum


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: no dressing (A)<br>No dressing will be applied at sacrum before 3.5 hours loading period in supine position | Other: No dressing<br>* no dressing at sacrum<br>|
| Active Comparator: Mepilex (B)<br>'Mepilex® Border Sacrum' dressing will be applied at sacrum before 3.5 hours loading period in supine position | Other: Mepilex® Border Sacrum<br>* adhesive sacrum dressing<br>|
| Active Comparator: Allevyn (C)<br>'ALLEVYN Life Sacrum' dressing will be applied at sacrum before 3.5 hours loading period in supine position | Other: ALLEVYN Life Sacrum<br>* adhesive sacrum dressing<br>|
| Active Comparator: Optifaom (D)<br>'Optifoam® Gentle Sacrum' Dressing will be applied at sacrum before 3.5 hours loading period in supine position | Other: Optifoam® Gentle Sacrum<br>* adhesive sacrum dressing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Skin Surface Temperature From Baseline | A skin thermometer based on infrared technique (Courage and Khazaka Electronic GmbH) was used to measure the skin surface temperature at the sacrum | Change from baseline after 3.5 hours loading period at visit 1 (Day 0), visit 2 (not before 3 weeks after visit 1), visit 3 (not before 3 weeks after visit 2), visit 4 (not before 3 weeks after visit 3). | 
| Change in Stratum Corneum Hydration (SCH) From Baseline | Corneometer CM 825 (Courage and Khazaka Electronic GmbH) was used to measure the stratum corneum hydration (SCH) at the sacrum in arbitrary units (AU) (range 0-120 AU). Lower values represent reduced skin hydration in the upper skin layer. The measurement is based on capacitance measurement of a dielectric medium. The change in the dielectric constant due to skin surface hydration by capacitance differences of a precision capacitor is measured. | Change from baseline after 3.5 hours loading period at visit 1 (Day 0), visit 2 (not before 3 weeks after visit 1), visit 3 (not before 3 weeks after visit 2), visit 4 (not before 3 weeks after visit 3). | 
| Change in Erythema Index (EI) From Baseline | Mexameter MX18 (Courage and Khazaka Electronic GmbH) was used to measure the Erythema index at the sacrum. This device uses specific wavelengths (the intensity of the reflected red (λ = 660 nm) and green (λ = 568 nm) lights) to measure the absorption capacity of the skin (specifically the content of hemoglobin in the skin) and presents values from 0 to 999. Lower values represent less redness. | Change from baseline after 3.5 hours loading period at visit 1 (Day 0), visit 2 (not before 3 weeks after visit 1), visit 3 (not before 3 weeks after visit 2), visit 4 (not before 3 weeks after visit 3). | 
| Change in Average Roughness (Rz) From Baseline | The Visioscan VC 98 camera (Courage and Khazaka Electronic GmbH) was used to capture images of the sacrum. The special LED UV light source with diffuser provides sharp, very high resolution images of the skin surface (255 grey levels representing different depths). The grey level distribution allows the calculation of different roughness parameters to quantitatively describe the skin surface. | Change from baseline after 3.5 hours loading period at visit 1 (Day 0), visit 2 (not before 3 weeks after visit 1), visit 3 (not before 3 weeks after visit 2), visit 4 (not before 3 weeks after visit 3). | 
| Change in Arithmetic Average Roughness (Ra) From Baseline | The Visioscan VC 98 camera (Courage and Khazaka Electronic GmbH) was used to capture images of the sacrum. The special LED UV light source with diffuser provides sharp, very high resolution images of the skin surface (255 grey levels representing different depths). The grey level distribution allows the calculation of different roughness parameters to quantitatively describe the skin surface. | Change from baseline after 3.5 hours loading period at visit 1 (Day 0), visit 2 (not before 3 weeks after visit 1), visit 3 (not before 3 weeks after visit 2), visit 4 (not before 3 weeks after visit 3). | 
| Change in Maximum Roughness (Rmax) From Baseline | The Visioscan VC 98 camera (Courage and Khazaka Electronic GmbH) was used to capture images of the sacrum. The special LED UV light source with diffuser provides sharp, very high resolution images of the skin surface (255 grey levels representing different depths). The grey level distribution allows the calculation of different roughness parameters to quantitatively describe the skin surface. | Change from baseline after 3.5 hours loading period at visit 1 (Day 0), visit 2 (not before 3 weeks after visit 1), visit 3 (not before 3 weeks after visit 2), visit 4 (not before 3 weeks after visit 3). | 
| Change in Interleukin IL-1alpha Concentration From Baseline | Based on Cyanoacrylate Skin Surface (CSSS)-Stripping, corneocytes was collected in order to analyse changes regarding interleukin IL-1alpha concentrations. | Change from baseline after 3.5 hours loading period at visit 1 (Day 0), visit 2 (not before 3 weeks after visit 1), visit 3 (not before 3 weeks after visit 2), visit 4 (not before 3 weeks after visit 3). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurence of Sacral Pain | The occurrence of pain (yes/no) | Captured from baseline until the end of the loading period after 3.5 hours at visit 1 (Day 0), visit 2 (not before 3 weeks after visit 1), visit 3 (not before 3 weeks after visit 2), visit 4 (not before 3 weeks after visit 3). | 
| Time Until First Reporting of Sacral Pain | Time from baseline until the subject reported pain at sacrum | Sacral pain was assessed from baseline up until 3.5 hours loading period at visit 1 (Day 0), visit 2 (not before 3 weeks after visit 1), visit 3 (not before 3 weeks after visit 2), visit 4 (not before 3 weeks after visit 3). | 
| Change in Erythema Score From Baseline | Erythema was assessed by visual inspection. A metric scale will be used: 0 = none 1 = mild (slight reddening), 2 = moderate (distinct redness), 3 = severe (strong redness, dark red) | Change from baseline after 3.5 hours loading period at visit 1 (Day 0), visit 2 (not before 3 weeks after visit 1), visit 3 (not before 3 weeks after visit 2), visit 4 (not before 3 weeks after visit 3). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pressure Ulcer Prevention, Preventive Dressings