Pressure Ulcer Prevention
Conditions
Keywords
Pressure Ulcer Prevention, Preventive Dressings
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 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
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.
Interventions
OTHERNo dressing
no dressing at sacrum
OTHERMepilex® Border Sacrum
adhesive sacrum dressing
OTHERALLEVYN Life Sacrum
adhesive sacrum dressing
OTHEROptifoam® Gentle Sacrum
adhesive sacrum dressing
Sponsors
Charite University, Berlin, Germany
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
65 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Interleukin IL-1alpha Concentration From Baseline | 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). | Based on Cyanoacrylate Skin Surface (CSSS)-Stripping, corneocytes was collected in order to analyse changes regarding interleukin IL-1alpha concentrations. |
| Change in Average Roughness (Rz) From Baseline | 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). | 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 in Arithmetic Average Roughness (Ra) From Baseline | 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). | 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 in Maximum Roughness (Rmax) From Baseline | 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). | 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 in Skin Surface Temperature From Baseline | 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). | A skin thermometer based on infrared technique (Courage and Khazaka Electronic GmbH) was used to measure the skin surface temperature at the sacrum |
| Change in Stratum Corneum Hydration (SCH) From Baseline | 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). | 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 in Erythema Index (EI) From Baseline | 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). | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time Until First Reporting of Sacral Pain | 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). | Time from baseline until the subject reported pain at sacrum |
| Change in Erythema Score From Baseline | 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). | 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) |
| Occurence of Sacral Pain | 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). | The occurrence of pain (yes/no) |
Countries
Germany
Participant flow
Recruitment details
The study took place at the Clinical Research Center for Hair and Skin Science in Berlin, Germany from January 2019 to July 2019 and involved 12 healthy female volunteers
Participants by arm
| Arm | Count |
|---|---|
| no Dressing, Mepilex, Allevyn, Optifoam (in Different Order) Cross-over study. Each of the 12 participants received each intervention once (no dressing, Mepilex® Border Sacrum, ALLEVYN Life Sacrum, Optifoam® Gentle Sacrum) | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | no Dressing, Mepilex, Allevyn, Optifoam (in Different Order) |
|---|---|
| Age, Continuous | 72.2 years STANDARD_DEVIATION 4.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 12 Participants |
| Region of Enrollment Germany | 12 participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 |
| other Total, other adverse events | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 |
Outcome results
Primary
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.
Time frame: 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).
Population: Cross-over study. Each of the 12 participants received each intervention once (total number is 12).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| no Dressing (A) | Change in Arithmetic Average Roughness (Ra) From Baseline | -0.8 micrometre |
| Mepilex (B) | Change in Arithmetic Average Roughness (Ra) From Baseline | -0.3 micrometre |
| Allevyn (C) | Change in Arithmetic Average Roughness (Ra) From Baseline | 0.5 micrometre |
| Optifaom (D) | Change in Arithmetic Average Roughness (Ra) From Baseline | -4.5 micrometre |
Primary
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.
Time frame: 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).
Population: Cross-over study. Each of the 12 participants received each intervention once (total number is 12).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| no Dressing (A) | Change in Average Roughness (Rz) From Baseline | -0.8 micrometre |
| Mepilex (B) | Change in Average Roughness (Rz) From Baseline | -1 micrometre |
| Allevyn (C) | Change in Average Roughness (Rz) From Baseline | -0.8 micrometre |
| Optifaom (D) | Change in Average Roughness (Rz) From Baseline | -6.3 micrometre |
Primary
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.
Time frame: 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).
Population: Cross-over study. Each of the 12 participants received each intervention once (total number is 12).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| no Dressing (A) | Change in Erythema Index (EI) From Baseline | 29 arbitrary units |
| Mepilex (B) | Change in Erythema Index (EI) From Baseline | 7 arbitrary units |
| Allevyn (C) | Change in Erythema Index (EI) From Baseline | 41 arbitrary units |
| Optifaom (D) | Change in Erythema Index (EI) From Baseline | 4 arbitrary units |
Primary
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.
Time frame: 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).
Population: Cross-over study. Each of the 12 participants received each intervention once (total number is 12).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| no Dressing (A) | Change in Interleukin IL-1alpha Concentration From Baseline | 1.1 picogramme/microgramme |
| Mepilex (B) | Change in Interleukin IL-1alpha Concentration From Baseline | -0.1 picogramme/microgramme |
| Allevyn (C) | Change in Interleukin IL-1alpha Concentration From Baseline | 1.3 picogramme/microgramme |
| Optifaom (D) | Change in Interleukin IL-1alpha Concentration From Baseline | 1.3 picogramme/microgramme |
Primary
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.
Time frame: 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).
Population: Cross-over study. Each of the 12 participants received each intervention once (total number is 12).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| no Dressing (A) | Change in Maximum Roughness (Rmax) From Baseline | -0.5 micrometre |
| Mepilex (B) | Change in Maximum Roughness (Rmax) From Baseline | -1.8 micrometre |
| Allevyn (C) | Change in Maximum Roughness (Rmax) From Baseline | -1.3 micrometre |
| Optifaom (D) | Change in Maximum Roughness (Rmax) From Baseline | -8.0 micrometre |
Primary
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
Time frame: 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).
Population: Cross-over study. Each of the 12 participants received each intervention once (total number is 12).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| no Dressing (A) | Change in Skin Surface Temperature From Baseline | 3.1 °C |
| Mepilex (B) | Change in Skin Surface Temperature From Baseline | 3.8 °C |
| Allevyn (C) | Change in Skin Surface Temperature From Baseline | 3.0 °C |
| Optifaom (D) | Change in Skin Surface Temperature From Baseline | 3.3 °C |
Primary
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.
Time frame: 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).
Population: Cross-over study. Each of the 12 participants received each intervention once (total number is 12).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| no Dressing (A) | Change in Stratum Corneum Hydration (SCH) From Baseline | 7.0 arbitrary units |
| Mepilex (B) | Change in Stratum Corneum Hydration (SCH) From Baseline | 4.4 arbitrary units |
| Allevyn (C) | Change in Stratum Corneum Hydration (SCH) From Baseline | 5.9 arbitrary units |
| Optifaom (D) | Change in Stratum Corneum Hydration (SCH) From Baseline | 7.3 arbitrary units |
Secondary
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)
Time frame: 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).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| no Dressing (A) | Change in Erythema Score From Baseline | no erythema | 9 Participants |
| no Dressing (A) | Change in Erythema Score From Baseline | moderate erythema | 0 Participants |
| no Dressing (A) | Change in Erythema Score From Baseline | mild erythema | 3 Participants |
| Mepilex (B) | Change in Erythema Score From Baseline | no erythema | 6 Participants |
| Mepilex (B) | Change in Erythema Score From Baseline | moderate erythema | 0 Participants |
| Mepilex (B) | Change in Erythema Score From Baseline | mild erythema | 6 Participants |
| Allevyn (C) | Change in Erythema Score From Baseline | mild erythema | 6 Participants |
| Allevyn (C) | Change in Erythema Score From Baseline | no erythema | 5 Participants |
| Allevyn (C) | Change in Erythema Score From Baseline | moderate erythema | 1 Participants |
| Optifaom (D) | Change in Erythema Score From Baseline | no erythema | 5 Participants |
| Optifaom (D) | Change in Erythema Score From Baseline | moderate erythema | 2 Participants |
| Optifaom (D) | Change in Erythema Score From Baseline | mild erythema | 5 Participants |
Secondary
Occurence of Sacral Pain
The occurrence of pain (yes/no)
Time frame: 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).
Population: Cross-over study. Each of the 12 participants received each intervention once (total number is 12).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| no Dressing (A) | Occurence of Sacral Pain | 0 Participants |
| Mepilex (B) | Occurence of Sacral Pain | 0 Participants |
| Allevyn (C) | Occurence of Sacral Pain | 0 Participants |
| Optifaom (D) | Occurence of Sacral Pain | 0 Participants |
Secondary
Time Until First Reporting of Sacral Pain
Time from baseline until the subject reported pain at sacrum
Time frame: 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).
Population: Cross-over study. Each of the 12 participants received each intervention once (total number is 12).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| no Dressing (A) | Time Until First Reporting of Sacral Pain | NA minutes |
| Mepilex (B) | Time Until First Reporting of Sacral Pain | NA minutes |
| Allevyn (C) | Time Until First Reporting of Sacral Pain | NA minutes |
| Optifaom (D) | Time Until First Reporting of Sacral Pain | NA minutes |