<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03824886</url>
  </required_header>
  <id_info>
    <org_study_id>CRC-SP-A-30</org_study_id>
    <nct_id>NCT03824886</nct_id>
  </id_info>
  <brief_title>Enhancing SKIN Health and Safety in Aged CARE</brief_title>
  <acronym>SKINCARE</acronym>
  <official_title>Enhancing SKIN Health and Safety in Aged CARE: An Exploratory Cluster Randomized Pragmatic Trial in Aged Nursing Home Residents (SKINCARE)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>PD Dr. Jan Kottner</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Charite University, Berlin, Germany</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Aged long-term care receivers are affected by various adverse skin conditions like pressure&#xD;
      ulcers, incontinence-associated dermatitis, dryness, intertrigo and many more. Prevention of&#xD;
      these skin problems and the provision of general hygiene and skin care activities are key&#xD;
      areas of nursing practice. Numerous condition specific guidelines are available and are&#xD;
      implemented separately. The more guidelines exist, the more difficult it is for nurses to&#xD;
      implement them all. On the other hand, there is a huge overlap in terms of aetiology,&#xD;
      pathogenesis and prevention of aforementioned skin conditions.&#xD;
&#xD;
      The overall aim of this trial is to test the feasibility and to estimate possible effects of&#xD;
      a comprehensive skin care package targeting main nursing relevant skin problems at the same&#xD;
      time. Therefore a study will be performed in nursing homes of the state of Berlin comparing&#xD;
      the skin care package to standard care. Residents' safety and subjective wellbeing will&#xD;
      increase combined with improvements in professional competence of nurses. An advisory board&#xD;
      consisting of international experts agreed already to supervise the trial.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objectives and aims:&#xD;
&#xD;
      Aged and care dependent patients suffer from many adverse skin conditions like xerosis cutis&#xD;
      (including pruritus), pressure ulcers, skin tears, intertrigo and incontinence-associated&#xD;
      dermatitis. Separate preventive strategies for these particular risks and diseases are&#xD;
      available and partly implemented. Although distinct clinical diagnoses, there are substantial&#xD;
      overlaps in terms of etiology (e.g. skin fragility, immobility) pathophysiology, prevention&#xD;
      (e.g. safe handling, off-loading) and treatment (e.g. skin protection and care). Facilities&#xD;
      are challenged to implement fragmented, condition-specific guidelines, neglecting shared&#xD;
      etiologies and prevention and treatment principles, which has been shown to be an important&#xD;
      barrier for implementation of evidence-based practice.&#xD;
&#xD;
      Recently an evidence-based comprehensive skin care algorithm was developed. The objective of&#xD;
      this trial is to investigate the feasibility of the implementation of this skin care package,&#xD;
      to describe context factors for implementation, to estimate effect sizes and intracluster&#xD;
      coefficients.&#xD;
&#xD;
      Study design:&#xD;
&#xD;
      An exploratory cluster randomized trial in aged nursing home residents will be conducted. The&#xD;
      cluster design was chosen to avoid contamination between groups. A total of n = 500 residents&#xD;
      from n = 20 nursing homes (randomly selected from the population of nursing homes of the&#xD;
      state of Berlin) will be included in the study. In the intervention group (n = 10 nursing&#xD;
      homes), the developed evidence-based algorithm will be implemented. The control group (n = 10&#xD;
      nursing homes) receives the usual standard care of the respective nursing home.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2018</start_date>
  <completion_date type="Actual">June 4, 2021</completion_date>
  <primary_completion_date type="Actual">June 4, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of Pressure Ulcers (PU) Category II, III, IV, Unstageable, Deep Tissue Injury (DTI)</measure>
    <time_frame>Week 12 +/- 1</time_frame>
    <description>Proportions of newly developed PUs per person and per skin area to calculate the cumulative incidence</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of Pressure Ulcers (PU) Category II, III, IV, Unstageable, Deep Tissue Injury (DTI)</measure>
    <time_frame>Week 24 +/- 1</time_frame>
    <description>Proportions of newly developed PUs per person and per skin area to calculate the cumulative incidence</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Location of Pressure Ulcers (PU) Category II, III, IV, Unstageable, Deep Tissue Injury (DTI)</measure>
    <time_frame>Week 12 +/- 1</time_frame>
    <description>Classification according to NPUAP (National Pressure Ulcer Advisory Panel)/EPUAP (European Pressure Ulcer Advisory Panel) 2014</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Location of Pressure Ulcers (PU) Category II, III, IV, Unstageable, Deep Tissue Injury (DTI)</measure>
    <time_frame>Week 24 +/- 1</time_frame>
    <description>Classification according to NPUAP (National Pressure Ulcer Advisory Panel)/EPUAP (European Pressure Ulcer Advisory Panel) 2014</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of Incontinence-associated Dermatitis (IAD)</measure>
    <time_frame>Week 12 +/- 1</time_frame>
    <description>Proportions of newly developed IAD per person and per skin area to calculate the cumulative incidence. The classification of IAD will be according to GLOBIAD (Ghent Global IAD Categorisation tool) and distinction between intact and eroded skin according to Proceedings of the Global IAD Expert Panel.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of Incontinence-associated Dermatitis (IAD)</measure>
    <time_frame>Week 24 +/- 1</time_frame>
    <description>Proportions of newly developed IAD per person and per skin area to calculate the cumulative incidence. The classification of IAD will be according to GLOBIAD (Ghent Global IAD Categorisation tool) and distinction between intact and eroded skin according to Proceedings of the Global IAD Expert Panel.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of Intertrigo</measure>
    <time_frame>Week 12 ± 1</time_frame>
    <description>Proportions of newly developed intertrigo per person and skin area to calculate the cumulative incidence. Medical diagnoses according to ICD (international classification of diseases) 11.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of Intertrigo</measure>
    <time_frame>Week 24 ± 1</time_frame>
    <description>Proportions of newly developed intertrigo per person and skin area to calculate the cumulative incidence. Medical diagnoses according to ICD (international code of diseases) 11.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of Skin Tears (ST)</measure>
    <time_frame>Week 12 ± 1</time_frame>
    <description>Proportions of newly developed STs per person and skin area to calculate the cumulative incidence. Classification according to ISTAP (International Skin Tear Advisory Panel).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of Skin Tears (ST)</measure>
    <time_frame>Week 24 ± 1</time_frame>
    <description>Proportions of newly developed STs per person and skin area to calculate the cumulative incidence. Classification according to ISTAP (International Skin Tear Advisory Panel).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Dry Skin Score (ODS) on face, trunk, arms, hands, feet, legs</measure>
    <time_frame>Week 0, Week 12 ± 1, Week 24 ± 1</time_frame>
    <description>Change in Overall Dry Skin score. ODS is a clinical assessment of the presence and severity of skin dryness using a five-point scale. A score of '0' indicates no skin dryness, whereas a score of '4' indicates advanced skin roughness, large scales, inflammation and cracks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stratum Corneum Hydration (SCH) measurements on right lower leg lateral, right midvolar forearm</measure>
    <time_frame>Week 0, Week 12 ± 1, Week 24 ± 1</time_frame>
    <description>Change in Stratum Corneum Hydration. SCH was measured using the Corneometer CM 825 (Courage + Khazaka, Cologne, Germany). This measurement is based on the differences of the dielectric constant of water and other substances. With this device, only the moisture content in the stratum corneum is measured. The arbitrary units (a.u.) range from 0 to 120 where as higher readings indicate higher stratum corneum hydration.&#xD;
Means of triplicate measurements per skin area in arbitrary units at right lower leg lateral, right midvolar forearm&#xD;
If measurements are not possible at right leg/arm (e.g. due to amputation) they will be conducted at contralateral skin areas</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Transepidermal Water Loss (TEWL) on right lower leg lateral, right midvolar forearm</measure>
    <time_frame>Week 0, Week 12 ± 1, Week 24 ± 1</time_frame>
    <description>Change in Transepidermal water loss. TEWL was measured with the Tewameter TM 300 (Courage + Khazaka, Cologne, Germany). The probe captures the constant permeation of water through the stratum corneum in gram per hour per m2. The measuring probe contains a pair of sensors that are located in different distances to the skin surface to determine temperature and relative humidity above the skin surface. The humidity gradient between both sensors is used for calculating the transepidermal water loss. Higher values indicate a higher transepidermal water loss.&#xD;
Means of duplicate measurements per skin area in g/m2/h at right lower leg lateral, right midvolar forearm&#xD;
If measurements are not possible at right leg/arm (e.g. due to amputation) they will be conducted at contralateral skin areas</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Skin Surface pH on right lower leg lateral, right midvolar forearm</measure>
    <time_frame>Week 0, Week 12 ± 1, Week 24 ± 1</time_frame>
    <description>Change in Skin surface pH. Skin surface pH was measured with the Skin-pH-Meter PH 905 (Courage + Khazaka, Cologne, Germany), a planar glass electrode. The pH is a measure of acidity and alkalinity of a solution and it indicates the concentration of the hydrogen ions in an aqueous solution. Reference values of human skin have been reported to range from 4 to 6.&#xD;
Means of duplicate measurements per skin area at right lower leg lateral, right midvolar forearm&#xD;
If measurements are not possible at right leg/arm (e.g. due to amputation) they will be conducted at contralateral skin areas</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Skin surface temperature [°C] on right lower leg lateral, right midvolar forearm</measure>
    <time_frame>Week 0, Week 12 ± 1, Week 24 ± 1</time_frame>
    <description>Skin surface temperature was measured with the Skin-Thermometer ST 500 (Courage+Khazaka electronic GmbH).&#xD;
Means of duplicate measurements per skin area in °C at right lower leg lateral, right midvolar forearm&#xD;
If measurements are not possible at right leg/arm (e.g. due to amputation) they will be conducted at contralateral skin areas</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life (QoL) (residents without cognitive impairment): WHO-Five Well-being Index (WHO = World Health Organization)</measure>
    <time_frame>Week 0, Week 24 ± 1</time_frame>
    <description>Self-completion of the WHO-Five Well-being Index by residents without cognitive impairment. The German version of the WHO-Five Well-being Index questionnaire published by the World Health Organization in 1998 will be used. Scores range from '5' (all the time) to '0' (never) for in total five items.The sum scores range from 0, indicating the lowest well-being, to 25, indicating the highest well-being. A cut-off score of &lt; 13 is recommended. Means will be calculated.&#xD;
◦ Means</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life (QoL) (cognitively impaired residents): QUALIDEM 18-Item Assessment (QUALIDEM = No original term, measurement instrument for proxy rating of quality of life in people with dementia)</measure>
    <time_frame>Week 0, Week 24 ± 1</time_frame>
    <description>The QUALIDEM assessment is a dementia-specific quality of life (QoL) instrument carried out by the nursing staff that allows a proxy-based QoL rating in all stages of dementia.The German version of the QUALIDEM version 2.0 published in 2015 will be used.Residents with a very severe dementia will answer the 18-item Instrument.To assess whether the resident is affected by mild to severe dementia or very severe dementia the global deterioration scale (GDS) will be used (see Outcome 22).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life (QoL) (cognitively impaired residents): QUALIDEM 37-Item Assessment</measure>
    <time_frame>Week 0, Week 24 ± 1</time_frame>
    <description>The QUALIDEM assessment is a dementia-specific quality of life (QoL) instrument carried out by the nursing staff that allows a proxy-based QoL rating in all stages of dementia.The German version of the QUALIDEM version 2.0 published in 2015 will be used.In case the resident is affected by a mild to severe dementia the 37-item assessment will be used.To assess whether the resident is affected by mild to severe dementia or very severe dementia the global deterioration scale (GDS) will be used (see Outcome 22).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Itch Assessment</measure>
    <time_frame>Week 0, Week 12 ± 1, Week 24 ± 1</time_frame>
    <description>Self-completion of the 5-D itch scale by residents without cognitive impairment (according to GDS score of 1)&#xD;
The score of the 5-D Itch scale ranges from '5' (no pruritus) to '25' (most severe pruritus) and contains five items measuring pruritus over the past two weeks.&#xD;
Means</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Assessment (residents without cognitive impairment): numeric rating scale</measure>
    <time_frame>Week 0, Week 12 ± 1, Week 24 ± 1</time_frame>
    <description>◦ Self-completion of a numeric rating scale (NRS with total scores from 0: minimum pain to 10: maximum pain) to measure pain by residents without cognitive impairment. Means of the total score will be calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Assessment (cognitively impaired residents): Verbal rating scale</measure>
    <time_frame>Week 0, Week 12 ± 1, Week 24 ± 1</time_frame>
    <description>◦ Verbal rating scale (proxy rated) to measure pain in cognitively impaired residents (VRS with total scores from 0: minimum pain to 10: maximum pain). Means of the total score will be calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assesment of dementia: Global Deterioration scale.</measure>
    <time_frame>Week 0</time_frame>
    <description>To assess whether the resident is affected by mild to severe dementia or very severe dementia the global deterioration scale (GDS) will be used. GDS scores from 2 to 6 indicate a mild to severe dementia and the 37-item assessment of the QUALIDEM tool will be used (see Outcome 18). A GDS score of 7 indicates very severe dementia and the 18-item QUALIDEM tool will be used (see Outcome 17).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">405</enrollment>
  <condition>Xerosis Cutis</condition>
  <condition>Dry Skin</condition>
  <condition>Pruritus</condition>
  <condition>Pressure Ulcer</condition>
  <condition>Intertrigo</condition>
  <condition>Incontinence-associated Dermatitis</condition>
  <condition>Skin Tear</condition>
  <condition>Skin Care</condition>
  <arm_group>
    <arm_group_label>Implementation of skin care algorithm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In the interventional nursing homes, a structured skin care prevention package based on a newly developed evidence-based skin care algorithm will be implemented at the nursing homes and delivered by nurses.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>In the control group, no additional intervention will be implemented. PU and IAD prevention and basic hygiene and skin care activities are routinely conducted in German nursing homes. This is considered as 'usual practice'.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Implementation of skin care algorithm</intervention_name>
    <description>Implementation of structured and standardized skin care regimen</description>
    <arm_group_label>Implementation of skin care algorithm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion/ Exclusion Criteria for Residents:&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Living in the nursing home,&#xD;
&#xD;
          -  65+ years,&#xD;
&#xD;
          -  'Care degree 2' or higher according to SGB XI (Sozialgesetzbuch (Codebook of Social&#xD;
             Law)),&#xD;
&#xD;
          -  Written informed consent (by legal representative if required)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Residents at end of life,&#xD;
&#xD;
          -  Any dermatological condition or skin affection requiring dermatological treatment,&#xD;
&#xD;
          -  Known allergies to any product ingredients&#xD;
&#xD;
        Inclusion/ Exclusion Criteria for Nursing Homes:&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Nursing home in the federal state of Berlin with at least n = 70 or more residents.&#xD;
&#xD;
          -  Expression of a clear commitment to implement the skin care algorithm if assigned to&#xD;
             the intervention group,&#xD;
&#xD;
          -  Valid pressure ulcer prevention standard/algorithm is in place,&#xD;
&#xD;
          -  Written commitment to adherence to the trial procedures regardless of the outcome of&#xD;
             randomisation. Exclusion criteria:&#xD;
&#xD;
          -  Nursing homes with less than n = 70 residents in the federal state of Berlin.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Nursing homes with less than n = 70 residents in the federal state of Berlin&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jan Kottner, Prof. Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Charite University, Berlin, Germany</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Charité - Universitätsmedizin Berlin</name>
      <address>
        <city>Berlin</city>
        <zip>10117</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charité-Universitätsmedizin Berlin</name>
      <address>
        <city>Berlin</city>
        <zip>10117</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>January 21, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>August 6, 2021</last_update_submitted>
  <last_update_submitted_qc>August 6, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 9, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Charite University, Berlin, Germany</investigator_affiliation>
    <investigator_full_name>PD Dr. Jan Kottner</investigator_full_name>
    <investigator_title>Scientific Director Clinical Research Center for Hair and Skin Science</investigator_title>
  </responsible_party>
  <keyword>Skin Integrity</keyword>
  <keyword>Aged Care Receivers</keyword>
  <keyword>Care Dependent</keyword>
  <keyword>Geriatric Patients</keyword>
  <keyword>Prevention</keyword>
  <keyword>Skin Protection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dermatitis</mesh_term>
    <mesh_term>Pruritus</mesh_term>
    <mesh_term>Pressure Ulcer</mesh_term>
    <mesh_term>Intertrigo</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03824886
org study id: CRC-SP-A-30
nct id: NCT03824886
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Aged long-term care receivers are affected by various adverse skin conditions like pressure
      ulcers, incontinence-associated dermatitis, dryness, intertrigo and many more. Prevention of
      these skin problems and the provision of general hygiene and skin care activities are key
      areas of nursing practice. Numerous condition specific guidelines are available and are
      implemented separately. The more guidelines exist, the more difficult it is for nurses to
      implement them all. On the other hand, there is a huge overlap in terms of aetiology,
      pathogenesis and prevention of aforementioned skin conditions.

      The overall aim of this trial is to test the feasibility and to estimate possible effects of
      a comprehensive skin care package targeting main nursing relevant skin problems at the same
      time. Therefore a study will be performed in nursing homes of the state of Berlin comparing
      the skin care package to standard care. Residents' safety and subjective wellbeing will
      increase combined with improvements in professional competence of nurses. An advisory board
      consisting of international experts agreed already to supervise the trial.
Objectives and aims:

      Aged and care dependent patients suffer from many adverse skin conditions like xerosis cutis
      (including pruritus), pressure ulcers, skin tears, intertrigo and incontinence-associated
      dermatitis. Separate preventive strategies for these particular risks and diseases are
      available and partly implemented. Although distinct clinical diagnoses, there are substantial
      overlaps in terms of etiology (e.g. skin fragility, immobility) pathophysiology, prevention
      (e.g. safe handling, off-loading) and treatment (e.g. skin protection and care). Facilities
      are challenged to implement fragmented, condition-specific guidelines, neglecting shared
      etiologies and prevention and treatment principles, which has been shown to be an important
      barrier for implementation of evidence-based practice.

      Recently an evidence-based comprehensive skin care algorithm was developed. The objective of
      this trial is to investigate the feasibility of the implementation of this skin care package,
      to describe context factors for implementation, to estimate effect sizes and intracluster
      coefficients.

      Study design:

      An exploratory cluster randomized trial in aged nursing home residents will be conducted. The
      cluster design was chosen to avoid contamination between groups. A total of n = 500 residents
      from n = 20 nursing homes (randomly selected from the population of nursing homes of the
      state of Berlin) will be included in the study. In the intervention group (n = 10 nursing
      homes), the developed evidence-based algorithm will be implemented. The control group (n = 10
      nursing homes) receives the usual standard care of the respective nursing home.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Incidence of Pressure Ulcers (PU) Category II, III, IV, Unstageable, Deep Tissue Injury (DTI)
time frame: Week 12 +/- 1
description: Proportions of newly developed PUs per person and per skin area to calculate the cumulative incidence
measure: Incidence of Pressure Ulcers (PU) Category II, III, IV, Unstageable, Deep Tissue Injury (DTI)
time frame: Week 24 +/- 1
description: Proportions of newly developed PUs per person and per skin area to calculate the cumulative incidence
measure: Location of Pressure Ulcers (PU) Category II, III, IV, Unstageable, Deep Tissue Injury (DTI)
time frame: Week 12 +/- 1
description: Classification according to NPUAP (National Pressure Ulcer Advisory Panel)/EPUAP (European Pressure Ulcer Advisory Panel) 2014
measure: Location of Pressure Ulcers (PU) Category II, III, IV, Unstageable, Deep Tissue Injury (DTI)
time frame: Week 24 +/- 1
description: Classification according to NPUAP (National Pressure Ulcer Advisory Panel)/EPUAP (European Pressure Ulcer Advisory Panel) 2014
measure: Incidence of Incontinence-associated Dermatitis (IAD)
time frame: Week 12 +/- 1
description: Proportions of newly developed IAD per person and per skin area to calculate the cumulative incidence. The classification of IAD will be according to GLOBIAD (Ghent Global IAD Categorisation tool) and distinction between intact and eroded skin according to Proceedings of the Global IAD Expert Panel.
measure: Incidence of Incontinence-associated Dermatitis (IAD)
time frame: Week 24 +/- 1
description: Proportions of newly developed IAD per person and per skin area to calculate the cumulative incidence. The classification of IAD will be according to GLOBIAD (Ghent Global IAD Categorisation tool) and distinction between intact and eroded skin according to Proceedings of the Global IAD Expert Panel.
measure: Incidence of Intertrigo
time frame: Week 12 ± 1
description: Proportions of newly developed intertrigo per person and skin area to calculate the cumulative incidence. Medical diagnoses according to ICD (international classification of diseases) 11.
measure: Incidence of Intertrigo
time frame: Week 24 ± 1
description: Proportions of newly developed intertrigo per person and skin area to calculate the cumulative incidence. Medical diagnoses according to ICD (international code of diseases) 11.
measure: Incidence of Skin Tears (ST)
time frame: Week 12 ± 1
description: Proportions of newly developed STs per person and skin area to calculate the cumulative incidence. Classification according to ISTAP (International Skin Tear Advisory Panel).
measure: Incidence of Skin Tears (ST)
time frame: Week 24 ± 1
description: Proportions of newly developed STs per person and skin area to calculate the cumulative incidence. Classification according to ISTAP (International Skin Tear Advisory Panel).
measure: Overall Dry Skin Score (ODS) on face, trunk, arms, hands, feet, legs
time frame: Week 0, Week 12 ± 1, Week 24 ± 1
description: Change in Overall Dry Skin score. ODS is a clinical assessment of the presence and severity of skin dryness using a five-point scale. A score of '0' indicates no skin dryness, whereas a score of '4' indicates advanced skin roughness, large scales, inflammation and cracks.
measure: Stratum Corneum Hydration (SCH) measurements on right lower leg lateral, right midvolar forearm
time frame: Week 0, Week 12 ± 1, Week 24 ± 1
description: Change in Stratum Corneum Hydration. SCH was measured using the Corneometer CM 825 (Courage + Khazaka, Cologne, Germany). This measurement is based on the differences of the dielectric constant of water and other substances. With this device, only the moisture content in the stratum corneum is measured. The arbitrary units (a.u.) range from 0 to 120 where as higher readings indicate higher stratum corneum hydration.
Means of triplicate measurements per skin area in arbitrary units at right lower leg lateral, right midvolar forearm
If measurements are not possible at right leg/arm (e.g. due to amputation) they will be conducted at contralateral skin areas
measure: Transepidermal Water Loss (TEWL) on right lower leg lateral, right midvolar forearm
time frame: Week 0, Week 12 ± 1, Week 24 ± 1
description: Change in Transepidermal water loss. TEWL was measured with the Tewameter TM 300 (Courage + Khazaka, Cologne, Germany). The probe captures the constant permeation of water through the stratum corneum in gram per hour per m2. The measuring probe contains a pair of sensors that are located in different distances to the skin surface to determine temperature and relative humidity above the skin surface. The humidity gradient between both sensors is used for calculating the transepidermal water loss. Higher values indicate a higher transepidermal water loss.
Means of duplicate measurements per skin area in g/m2/h at right lower leg lateral, right midvolar forearm
If measurements are not possible at right leg/arm (e.g. due to amputation) they will be conducted at contralateral skin areas
measure: Skin Surface pH on right lower leg lateral, right midvolar forearm
time frame: Week 0, Week 12 ± 1, Week 24 ± 1
description: Change in Skin surface pH. Skin surface pH was measured with the Skin-pH-Meter PH 905 (Courage + Khazaka, Cologne, Germany), a planar glass electrode. The pH is a measure of acidity and alkalinity of a solution and it indicates the concentration of the hydrogen ions in an aqueous solution. Reference values of human skin have been reported to range from 4 to 6.
Means of duplicate measurements per skin area at right lower leg lateral, right midvolar forearm
If measurements are not possible at right leg/arm (e.g. due to amputation) they will be conducted at contralateral skin areas
measure: Skin surface temperature [°C] on right lower leg lateral, right midvolar forearm
time frame: Week 0, Week 12 ± 1, Week 24 ± 1
description: Skin surface temperature was measured with the Skin-Thermometer ST 500 (Courage+Khazaka electronic GmbH).
Means of duplicate measurements per skin area in °C at right lower leg lateral, right midvolar forearm
If measurements are not possible at right leg/arm (e.g. due to amputation) they will be conducted at contralateral skin areas
measure: Quality of Life (QoL) (residents without cognitive impairment): WHO-Five Well-being Index (WHO = World Health Organization)
time frame: Week 0, Week 24 ± 1
description: Self-completion of the WHO-Five Well-being Index by residents without cognitive impairment. The German version of the WHO-Five Well-being Index questionnaire published by the World Health Organization in 1998 will be used. Scores range from '5' (all the time) to '0' (never) for in total five items.The sum scores range from 0, indicating the lowest well-being, to 25, indicating the highest well-being. A cut-off score of < 13 is recommended. Means will be calculated.
◦ Means
measure: Quality of Life (QoL) (cognitively impaired residents): QUALIDEM 18-Item Assessment (QUALIDEM = No original term, measurement instrument for proxy rating of quality of life in people with dementia)
time frame: Week 0, Week 24 ± 1
description: The QUALIDEM assessment is a dementia-specific quality of life (QoL) instrument carried out by the nursing staff that allows a proxy-based QoL rating in all stages of dementia.The German version of the QUALIDEM version 2.0 published in 2015 will be used.Residents with a very severe dementia will answer the 18-item Instrument.To assess whether the resident is affected by mild to severe dementia or very severe dementia the global deterioration scale (GDS) will be used (see Outcome 22).
measure: Quality of Life (QoL) (cognitively impaired residents): QUALIDEM 37-Item Assessment
time frame: Week 0, Week 24 ± 1
description: The QUALIDEM assessment is a dementia-specific quality of life (QoL) instrument carried out by the nursing staff that allows a proxy-based QoL rating in all stages of dementia.The German version of the QUALIDEM version 2.0 published in 2015 will be used.In case the resident is affected by a mild to severe dementia the 37-item assessment will be used.To assess whether the resident is affected by mild to severe dementia or very severe dementia the global deterioration scale (GDS) will be used (see Outcome 22).
measure: Itch Assessment
time frame: Week 0, Week 12 ± 1, Week 24 ± 1
description: Self-completion of the 5-D itch scale by residents without cognitive impairment (according to GDS score of 1)
The score of the 5-D Itch scale ranges from '5' (no pruritus) to '25' (most severe pruritus) and contains five items measuring pruritus over the past two weeks.
Means
measure: Pain Assessment (residents without cognitive impairment): numeric rating scale
time frame: Week 0, Week 12 ± 1, Week 24 ± 1
description: ◦ Self-completion of a numeric rating scale (NRS with total scores from 0: minimum pain to 10: maximum pain) to measure pain by residents without cognitive impairment. Means of the total score will be calculated.
measure: Pain Assessment (cognitively impaired residents): Verbal rating scale
time frame: Week 0, Week 12 ± 1, Week 24 ± 1
description: ◦ Verbal rating scale (proxy rated) to measure pain in cognitively impaired residents (VRS with total scores from 0: minimum pain to 10: maximum pain). Means of the total score will be calculated.
measure: Assesment of dementia: Global Deterioration scale.
time frame: Week 0
description: To assess whether the resident is affected by mild to severe dementia or very severe dementia the global deterioration scale (GDS) will be used. GDS scores from 2 to 6 indicate a mild to severe dementia and the 37-item assessment of the QUALIDEM tool will be used (see Outcome 18). A GDS score of 7 indicates very severe dementia and the 18-item QUALIDEM tool will be used (see Outcome 17).
arm group label: Implementation of skin care algorithm
arm group type: Experimental
description: In the interventional nursing homes, a structured skin care prevention package based on a newly developed evidence-based skin care algorithm will be implemented at the nursing homes and delivered by nurses.
arm group label: Standard Care
arm group type: No Intervention
description: In the control group, no additional intervention will be implemented. PU and IAD prevention and basic hygiene and skin care activities are routinely conducted in German nursing homes. This is considered as 'usual practice'.
intervention type: Other
intervention name: Implementation of skin care algorithm
description: Implementation of structured and standardized skin care regimen
arm group label: Implementation of skin care algorithm
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jan Kottner, Prof. Dr.
role: Principal Investigator
affiliation: Charite University, Berlin, Germany
facility: 
facility: 
country: Germany
responsible party type: Sponsor-Investigator
investigator affiliation: Charite University, Berlin, Germany
investigator full name: PD Dr. Jan Kottner
investigator title: Scientific Director Clinical Research Center for Hair and Skin Science
mesh term: Dermatitis
mesh term: Pruritus
mesh term: Pressure Ulcer
mesh term: Intertrigo
sharing ipd: Undecided