Xerosis CutisSKINCARENCT03824886
Enhancing SKIN Health and Safety in Aged CARE
A study testing Implementation of skin care algorithm in people with Xerosis Cutis and Dry Skin, run by PD Dr. Jan Kottner at 2 sites in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Xerosis Cutis, Dry Skin, Pruritus
- What is being tested?
- Implementation of skin care algorithm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 405 participants
- Where
- 2 sitesGermany
- Study dates
- 1 Oct 2018to 4 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Living in the nursing home,
- 65+ years,
- 'Care degree 2' or higher according to SGB XI (Sozialgesetzbuch (Codebook of Social Law)),
- Written informed consent (by legal representative if required)
- Nursing home in the federal state of Berlin with at least n = 70 or more residents.
- Expression of a clear commitment to implement the skin care algorithm if assigned to the intervention group,
Show all 9Show fewer
- Valid pressure ulcer prevention standard/algorithm is in place,
- Written commitment to adherence to the trial procedures regardless of the outcome of randomisation. Exclusion criteria:
- Nursing homes with less than n = 70 residents in the federal state of Berlin.
Who cannot join
- Residents at end of life,
- Any dermatological condition or skin affection requiring dermatological treatment,
- Known allergies to any product ingredients
- Nursing homes with less than n = 70 residents in the federal state of Berlin
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Charité - Universitätsmedizin Berlin
Berlin, 10117
Charité-Universitätsmedizin Berlin
Berlin, 10117
About this study
Official title: Enhancing SKIN Health and Safety in Aged CARE: An Exploratory Cluster Randomized Pragmatic Trial in Aged Nursing Home Residents (SKINCARE)
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.
Read the detailed description
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.
- Conditions
- Xerosis Cutis, Dry Skin, Pruritus, Pressure Ulcer, Intertrigo, Incontinence-associated Dermatitis
- Being tested
- Implementation of skin care algorithm
- Keywords
- Skin Integrity, Aged Care Receivers, Care Dependent, Geriatric Patients, Prevention, Skin Protection
- Medical subject headings
- Pruritus, Pressure Ulcer, Intertrigo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation of skin care algorithmOther
Implementation of structured and standardized skin care regimen
| Study group | Role | What they receive |
|---|---|---|
| Implementation of skin care algorithm | Experimental | 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. Receives: Other: Implementation of skin care algorithm |
| Standard Care | No intervention | 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'. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Pressure Ulcers (PU) Category II, III, IV, Unstageable, Deep Tissue Injury (DTI)
Proportions of newly developed PUs per person and per skin area to calculate the cumulative incidence
Measured: Week 12 +/- 1
Incidence of Pressure Ulcers (PU) Category II, III, IV, Unstageable, Deep Tissue Injury (DTI)
Proportions of newly developed PUs per person and per skin area to calculate the cumulative incidence
Measured: Week 24 +/- 1
Location of Pressure Ulcers (PU) Category II, III, IV, Unstageable, Deep Tissue Injury (DTI)
Classification according to NPUAP (National Pressure Ulcer Advisory Panel)/EPUAP (European Pressure Ulcer Advisory Panel) 2014
Measured: Week 12 +/- 1
Location of Pressure Ulcers (PU) Category II, III, IV, Unstageable, Deep Tissue Injury (DTI)
Classification according to NPUAP (National Pressure Ulcer Advisory Panel)/EPUAP (European Pressure Ulcer Advisory Panel) 2014
Measured: Week 24 +/- 1
Incidence of Incontinence-associated Dermatitis (IAD)
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.
Measured: Week 12 +/- 1
Incidence of Incontinence-associated Dermatitis (IAD)
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.
Measured: Week 24 +/- 1
Incidence of Intertrigo
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.
Measured: Week 12 ± 1
Incidence of Intertrigo
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.
Measured: Week 24 ± 1
Incidence of Skin Tears (ST)
Proportions of newly developed STs per person and skin area to calculate the cumulative incidence. Classification according to ISTAP (International Skin Tear Advisory Panel).
Measured: Week 12 ± 1
Incidence of Skin Tears (ST)
Proportions of newly developed STs per person and skin area to calculate the cumulative incidence. Classification according to ISTAP (International Skin Tear Advisory Panel).
Measured: Week 24 ± 1
Secondary outcomes (12)
Overall Dry Skin Score (ODS) on face, trunk, arms, hands, feet, legs
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.
Measured: Week 0, Week 12 ± 1, Week 24 ± 1
Stratum Corneum Hydration (SCH) measurements on right lower leg lateral, right midvolar forearm
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
Measured: Week 0, Week 12 ± 1, Week 24 ± 1
Transepidermal Water Loss (TEWL) on right lower leg lateral, right midvolar forearm
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
Measured: Week 0, Week 12 ± 1, Week 24 ± 1
Skin Surface pH on right lower leg lateral, right midvolar forearm
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
Measured: Week 0, Week 12 ± 1, Week 24 ± 1
Skin surface temperature [°C] on right lower leg lateral, right midvolar forearm
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
Measured: Week 0, Week 12 ± 1, Week 24 ± 1
Quality of Life (QoL) (residents without cognitive impairment): WHO-Five Well-being Index (WHO = World Health Organization)
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
Measured: Week 0, Week 24 ± 1
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)
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).
Measured: Week 0, Week 24 ± 1
Quality of Life (QoL) (cognitively impaired residents): QUALIDEM 37-Item Assessment
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).
Measured: Week 0, Week 24 ± 1
Itch Assessment
- 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
Measured: Week 0, Week 12 ± 1, Week 24 ± 1
Pain Assessment (residents without cognitive impairment): numeric rating scale
◦ 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.
Measured: Week 0, Week 12 ± 1, Week 24 ± 1
Pain Assessment (cognitively impaired residents): Verbal rating scale
◦ 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.
Measured: Week 0, Week 12 ± 1, Week 24 ± 1
Assesment of dementia: Global Deterioration scale.
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).
Measured: Week 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2019
- Study start1 Oct 2018
- Primary completion4 Jun 2021
- Study completion4 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Xerosis CutisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 405 participants (actual)
Sponsor and investigators
- Lead sponsor
- PD Dr. Jan Kottner
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, PD Dr. Jan Kottner, Charite University, Berlin, Germany
- Investigators
- Jan Kottner, Prof. Dr., Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03824886
- Sponsor's protocol ID
- CRC-SP-A-30
- Acronym
- SKINCARE
- Status last verified
- Aug 2021
- First submitted
- 21 Jan 2019
- Last updated
- 9 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Amin R, Volzer B, El Genedy-Kalyoncu M, Blume-Peytavi U, Kottner J. Skin care types, frequencies and products: A cross-sectional study in German institutional long-term care. J Tissue Viability. 2024 May;33(2):318-323. doi: 10.1016/j.jtv.2024.02.005. Epub 2024 Feb 10.
PubMed 38360494Volzer B, El Genedy-Kalyoncu M, Fastner A, Tomova-Simitchieva T, Neumann K, Hillmann K, Blume-Peytavi U, Hahnel E, Sill J, Balzer K, Kottner J. Enhancing skin health and safety in aged care (SKINCARE trial): A cluster-randomised pragmatic trial. Int J Nurs Stud. 2024 Jan;149:104627. doi: 10.1016/j.ijnurstu.2023.104627. Epub 2023 Oct 28.
PubMed 37956524Volzer B, El Genedy-Kalyoncu M, Fastner A, Tomova-Simitchieva T, Neumann K, Sill J, Balzer K, Kottner J. Prevalence and associations of xerosis cutis, incontinence-associated dermatitis, skin tears, pressure ulcers, and intertrigo in aged nursing home residents: A representative prevalence study. Int J Nurs Stud. 2023 May;141:104472. doi: 10.1016/j.ijnurstu.2023.104472. Epub 2023 Feb 23.
PubMed 36898269Kottner J, Hahnel E, El Genedy M, Neumann K, Balzer K. Enhancing SKIN health and safety in aged CARE (SKINCARE Trial): a study protocol for an exploratory cluster-randomized pragmatic trial. Trials. 2019 May 29;20(1):302. doi: 10.1186/s13063-019-3375-7.
PubMed 31142364
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing SKIN Health and Safety in Aged CARE: An Exploratory Cluster Randomized Pragmatic Trial in Aged Nursing Home Residents (SKINCARE)
- ClinicalTrials.gov ID
- NCT03824886
- Acronym / sponsor ID
- SKINCARE / CRC-SP-A-30
- Conditions
- Xerosis Cutis, Dry Skin, Pruritus, Pressure Ulcer, Intertrigo, Incontinence-associated Dermatitis
- Keywords
- Skin Integrity, Aged Care Receivers, Care Dependent, Geriatric Patients, Prevention, Skin Protection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 405 participants (actual)
- Lead sponsor
- PD Dr. Jan KottnerUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 4 Jun 2021 (actual)
- Study completion
- 4 Jun 2021 (actual)
- First posted
- 31 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Implementation of skin care algorithm | Experimental | Other: Implementation of skin care algorithmIn 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. |
| Standard Care | No intervention | –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'. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- Living in the nursing home,
- 65+ years,
- 'Care degree 2' or higher according to SGB XI (Sozialgesetzbuch (Codebook of Social Law)),
- Written informed consent (by legal representative if required)
- Nursing home in the federal state of Berlin with at least n = 70 or more residents.
Key exclusion criteria (4 listed)
- Residents at end of life,
- Any dermatological condition or skin affection requiring dermatological treatment,
- Known allergies to any product ingredients
- Nursing homes with less than n = 70 residents in the federal state of Berlin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implementation of skin care algorithmImplementation of structured and standardized skin care regimen | Other | Implementation of skin care algorithm |
Primary outcome
Incidence of Pressure Ulcers (PU) Category II, III, IV, Unstageable, Deep Tissue Injury (DTI)
Time frame: Week 12 +/- 1
Proportions of newly developed PUs per person and per skin area to calculate the cumulative incidence
Incidence of Pressure Ulcers (PU) Category II, III, IV, Unstageable, Deep Tissue Injury (DTI)
Time frame: Week 24 +/- 1
Proportions of newly developed PUs per person and per skin area to calculate the cumulative incidence
Location of Pressure Ulcers (PU) Category II, III, IV, Unstageable, Deep Tissue Injury (DTI)
Time frame: Week 12 +/- 1
Classification according to NPUAP (National Pressure Ulcer Advisory Panel)/EPUAP (European Pressure Ulcer Advisory Panel) 2014
Location of Pressure Ulcers (PU) Category II, III, IV, Unstageable, Deep Tissue Injury (DTI)
Time frame: Week 24 +/- 1
Classification according to NPUAP (National Pressure Ulcer Advisory Panel)/EPUAP (European Pressure Ulcer Advisory Panel) 2014
Incidence of Incontinence-associated Dermatitis (IAD)
Time frame: Week 12 +/- 1
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.
Incidence of Incontinence-associated Dermatitis (IAD)
Time frame: Week 24 +/- 1
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.
Incidence of Intertrigo
Time frame: Week 12 ± 1
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.
Incidence of Intertrigo
Time frame: Week 24 ± 1
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.
Incidence of Skin Tears (ST)
Time frame: Week 12 ± 1
Proportions of newly developed STs per person and skin area to calculate the cumulative incidence. Classification according to ISTAP (International Skin Tear Advisory Panel).
Incidence of Skin Tears (ST)
Time frame: Week 24 ± 1
Proportions of newly developed STs per person and skin area to calculate the cumulative incidence. Classification according to ISTAP (International Skin Tear Advisory Panel).
12 secondary outcomes
Overall Dry Skin Score (ODS) on face, trunk, arms, hands, feet, legs
Time frame: Week 0, Week 12 ± 1, Week 24 ± 1
Stratum Corneum Hydration (SCH) measurements on right lower leg lateral, right midvolar forearm
Time frame: Week 0, Week 12 ± 1, Week 24 ± 1
Transepidermal Water Loss (TEWL) on right lower leg lateral, right midvolar forearm
Time frame: Week 0, Week 12 ± 1, Week 24 ± 1
Skin Surface pH on right lower leg lateral, right midvolar forearm
Time frame: Week 0, Week 12 ± 1, Week 24 ± 1
Skin surface temperature [°C] on right lower leg lateral, right midvolar forearm
Time frame: Week 0, Week 12 ± 1, Week 24 ± 1
Quality of Life (QoL) (residents without cognitive impairment): WHO-Five Well-being Index (WHO = World Health Organization)
Time frame: Week 0, Week 24 ± 1
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
Quality of Life (QoL) (cognitively impaired residents): QUALIDEM 37-Item Assessment
Time frame: Week 0, Week 24 ± 1
Itch Assessment
Time frame: Week 0, Week 12 ± 1, Week 24 ± 1
Pain Assessment (residents without cognitive impairment): numeric rating scale
Time frame: Week 0, Week 12 ± 1, Week 24 ± 1
Pain Assessment (cognitively impaired residents): Verbal rating scale
Time frame: Week 0, Week 12 ± 1, Week 24 ± 1
Assesment of dementia: Global Deterioration scale.
Time frame: Week 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2021.
- Derived from this study: PubMed 38360494Amin R, Volzer B, El Genedy-Kalyoncu M, Blume-Peytavi U, Kottner J. Skin care types, frequencies and products: A cross-sectional study in German institutional long-term care. J Tissue Viability. 2024 May;33(2):318-323. doi: 10.1016/j.jtv.2024.02.005. Epub 2024 Feb 10.
- Derived from this study: PubMed 37956524Volzer B, El Genedy-Kalyoncu M, Fastner A, Tomova-Simitchieva T, Neumann K, Hillmann K, Blume-Peytavi U, Hahnel E, Sill J, Balzer K, Kottner J. Enhancing skin health and safety in aged care (SKINCARE trial): A cluster-randomised pragmatic trial. Int J Nurs Stud. 2024 Jan;149:104627. doi: 10.1016/j.ijnurstu.2023.104627. Epub 2023 Oct 28.
- Derived from this study: PubMed 36898269Volzer B, El Genedy-Kalyoncu M, Fastner A, Tomova-Simitchieva T, Neumann K, Sill J, Balzer K, Kottner J. Prevalence and associations of xerosis cutis, incontinence-associated dermatitis, skin tears, pressure ulcers, and intertrigo in aged nursing home residents: A representative prevalence study. Int J Nurs Stud. 2023 May;141:104472. doi: 10.1016/j.ijnurstu.2023.104472. Epub 2023 Feb 23.
- Derived from this study: PubMed 31142364Kottner J, Hahnel E, El Genedy M, Neumann K, Balzer K. Enhancing SKIN health and safety in aged CARE (SKINCARE Trial): a study protocol for an exploratory cluster-randomized pragmatic trial. Trials. 2019 May 29;20(1):302. doi: 10.1186/s13063-019-3375-7.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Kottner, Prof. Dr. principal investigator
Charite University, Berlin, Germany
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implementation of skin care algorithm in people with Xerosis Cutis and Dry Skin, run by PD Dr. Jan Kottner at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Pressure Ulcers (PU) Category II, III, IV, Unstageable, Deep Tissue Injury (DTI) (time frame: Week 12 +/- 1). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03824886, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2021.