Enhancing SKIN Health and Safety in Aged CARE

NCT03824886 | Completed

• 1 other identifier: CRC-SP-A-30
• Study Type: interventional
• Target: 405
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Xerosis Cutis; Dry Skin; Pruritus; Pressure Ulcer; Intertrigo; Incontinence-associated Dermatitis; Skin Tear; Skin Care

Keywords

Skin Integrity; Aged Care Receivers; Care Dependent; Geriatric Patients; Prevention; Skin Protection

Outcome Measures

Primary Outcomes (10)

• 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

  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

  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

  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

  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.

  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.

  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.

  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.

  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).

  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).

  Week 24 ± 1

Secondary Outcomes (12)

• Overall Dry Skin Score (ODS) on face, trunk, arms, hands, feet, legs

  Week 0, Week 12 ± 1, Week 24 ± 1

• Stratum Corneum Hydration (SCH) measurements on right lower leg lateral, right midvolar forearm

  Week 0, Week 12 ± 1, Week 24 ± 1

• Transepidermal Water Loss (TEWL) on right lower leg lateral, right midvolar forearm

  Week 0, Week 12 ± 1, Week 24 ± 1

• Skin Surface pH on right lower leg lateral, right midvolar forearm

  Week 0, Week 12 ± 1, Week 24 ± 1

• Skin surface temperature [°C] on right lower leg lateral, right midvolar forearm

  Week 0, Week 12 ± 1, Week 24 ± 1

Study Arms (2)

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.

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'.

Interventions

Implementation of skin care algorithm OTHER

Implementation of structured and standardized skin care regimen

Implementation of skin care algorithm

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may not qualify if:

• Living in the nursing home,
• + years,
• 'Care degree 2' or higher according to SGB XI (Sozialgesetzbuch (Codebook of Social Law)),
• Written informed consent (by legal representative if required)
• Residents at end of life,
• Any dermatological condition or skin affection requiring dermatological treatment,
• Known allergies to any product ingredients
• 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,
• Valid pressure ulcer prevention standard/algorithm is in place,
• Nursing homes with less than n = 70 residents in the federal state of Berlin.
• Nursing homes with less than n = 70 residents in the federal state of Berlin

Sponsors & Collaborators

• PD Dr. Jan Kottner: lead

Study Sites (2)

Charité - Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

Charité-Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

Related Publications (4)

• 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.

  PMID: 38360494 DERIVED

• Volzer 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.

  PMID: 37956524 DERIVED

• Volzer 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.

  PMID: 36898269 DERIVED

• Kottner 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.

  PMID: 31142364 DERIVED

MeSH Terms

Conditions

Pruritus; Pressure Ulcer; Intertrigo

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Skin Ulcer; Dermatitis; Skin Diseases, Eczematous

Study Officials

• Jan Kottner, Prof. Dr.

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Scientific Director Clinical Research Center for Hair and Skin Science

Study Record Dates

• First Submitted: January 21, 2019
• First Posted: January 31, 2019
• Study Start: October 1, 2018
• Primary Completion: June 4, 2021
• Study Completion: June 4, 2021
• Last Updated: August 9, 2021

Record last verified: 2021-08

Locations

DE (2)