Enhancing SKIN Health and Safety in Aged CARE

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

405 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2021-06-04

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Skin Health and Effectiveness of Standardized Skin Care Regimens in Nursing Home Residents

NCT02216526

Xerosis Cutis

COMPLETED NA

Impact on Elderly Skin Due to Wet Pad Application.

NCT06248255

Incontinence

COMPLETED NA

How Wet Pads Affect Elderly Skin: Measuring Changes in the Skin Barrier

NCT07164898

Incontinence-associated Dermatitis

COMPLETED NA

Histopathological Comparison Between Superficial Pressure Ulcers and Incontinence-associated Dermatitis

NCT03685929

Pressure Ulcer Incontinence-associated Dermatitis Irritant Contact Dermatitis +1 more

COMPLETED

Prevention of Incontinence-associated Dermatitis

NCT05403762

Incontinence-associated Dermatitis

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Implementation of skin care algorithm

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.

Group Type EXPERIMENTAL

Implementation of skin care algorithm

Intervention Type OTHER

Implementation of structured and standardized skin care regimen

Standard Care

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'.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Implementation of skin care algorithm

Implementation of structured and standardized skin care regimen

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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,
* Valid pressure ulcer prevention standard/algorithm is in place,

Exclusion Criteria

* 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.

* Nursing homes with less than n = 70 residents in the federal state of Berlin

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes