NCT03824886: SKINCARE

Enhancing SKIN Health and Safety in Aged CARE

Completed NA Last updated 9 August 2021

What this trial tests

NA trial testing Implementation of skin care algorithm in Xerosis Cutis in 405 participants. Completed in 4 June 2021.

Timeline

1 October 2018

Primary endpoint
4 June 2021

4 June 2021

Quick facts

Lead sponsor	PD Dr. Jan Kottner
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	405
Start date	1 October 2018
Primary completion	4 June 2021
Estimated completion	4 June 2021
Sites	2 locations across Germany

Drugs / interventions tested

• Implementation of skin care algorithm

Conditions studied

• Xerosis Cutis — all drugs for Xerosis Cutis →
• Dry Skin — all drugs for Dry Skin →
• Pruritus — all drugs for Pruritus →
• Pressure Ulcer — all drugs for Pressure Ulcer →

Sponsor

PD Dr. Jan Kottner

Who can join

65 and older, any sex, with Xerosis Cutis or Dry Skin. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Prevalence and associations of xerosis cutis, incontinence-associated dermatitis, skin tears, pressure ulcers, and intertrigo in aged nursing home residents: A representative prevalence study.
   Völzer B, El Genedy-Kalyoncu M, Fastner A, Tomova-Simitchieva T, et al · · 2023 · cited 34× · PMID 36898269 · DOI 10.1016/j.ijnurstu.2023.104472
2. Enhancing SKIN health and safety in aged CARE (SKINCARE Trial): a study protocol for an exploratory cluster-randomized pragmatic trial.
   Kottner J, Hahnel E, El Genedy M, Neumann K, et al · · 2019 · cited 13× · PMID 31142364 · DOI 10.1186/s13063-019-3375-7
3. Enhancing skin health and safety in aged care (SKINCARE trial): A cluster-randomised pragmatic trial.
   Völzer B, El Genedy-Kalyoncu M, Fastner A, Tomova-Simitchieva T, et al · · 2024 · cited 9× · PMID 37956524 · DOI 10.1016/j.ijnurstu.2023.104627
4. Clinical Measurement of Transepidermal Water Loss.
   Kundu D, Jayaraman A, Sen CK. · · 2026 · cited 4× · PMID 40476522 · DOI 10.1089/wound.2024.0148
5. Identification of risk factors and development of a multivariable prognostic prediction model for incontinence-associated dermatitis in older nursing home residents.
   El Genedy-Kalyoncu M, Völzer B, Kottner J. · · 2026 · cited 1× · PMID 41708806 · DOI 10.1038/s41598-026-40416-7
6. Skin care types, frequencies and products: A cross-sectional study in German institutional long-term care.
   Amin R, Völzer B, El Genedy-Kalyoncu M, Blume-Peytavi U, et al · · 2024 · cited 1× · PMID 38360494 · DOI 10.1016/j.jtv.2024.02.005
7. Development of a multivariable prognostic prediction model for skin tears in older nursing home residents.
   El Genedy-Kalyoncu M, Völzer B, Kottner J. · · 2025 · PMID 40175500 · DOI 10.1038/s41598-025-95944-5