Clinical Trials Logo
  1. Home
  2. Skin Care
  3. NCT03824886

Enhancing SKIN Health and Safety in Aged CARE — SKINCARE  

Pressure Ulcer Clinical Trial

Official title:
Enhancing SKIN Health and Safety in Aged CARE: An Exploratory Cluster Randomized Pragmatic Trial in Aged Nursing Home Residents (SKINCARE)

Clinical 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. 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03824886
Study type Interventional
Source Charite University, Berlin, Germany
Contact
Status Completed
Phase N/A
Start date October 1, 2018
Completion date June 4, 2021
View Details
See also
  Status Clinical Trial Phase
Completed NCT03351049 - An RCT on Support Surfaces for Pressure Ulcer Prevention N/A
Completed NCT05112068 - Comparative Assessment of Effectiveness and Safety of Methods for Skin and Hair Care in Severe Intensive Care Unit Patients
Completed NCT05575869 - Evaluation of the Impact of the PRONEtect Education Hub vs. Classic Lecture, on the Competencies of Nursing Students N/A
Completed NCT03220451 - Use of Adhesive Elastic Taping for the Therapy of Medium/Severe Pressure Ulcers in Spinal Cord Injured Patients N/A
Terminated NCT05234632 - Study to Evaluate the PICO 14 Negative Pressure Wound Therapy System in the Management of Acute and Chronic Wounds N/A
Completed NCT04540822 - Peripheral Catheter Pressure Ulcer Prevention in Pediatry : Use of Compresses Versus Standard Care N/A
Terminated NCT01966380 - Proof of Concept (Design Validation) in Patient With Hard to Heal Wounds Such as Pressure Ulcer, Diabetic Foot Ulcer and Leg Ulcer, Leia Phase 2
Completed NCT02092870 - Adipose Derived Regenerative Cellular Therapy of Chronic Wounds Phase 2
Completed NCT01438541 - A Multi-centre Evaluation of the Performance of Window Dressings on Subjects With High Risk Pressure Ulceration Phase 4
Completed NCT00365430 - SAFE or SORRY? Patient Safety Study of the Prevention of Adverse Patient Outcomes N/A
Completed NCT04251897 - Novel Support Surface to Alleviate Pressure Ulcer N/A
Completed NCT03391310 - Use of Honey for Pressure Ulcers in Critically Ill Children N/A
Recruiting NCT04559165 - Efficacy and Safety of Sericin and Chitosan Cream for Preventing and Limiting the Progressive of Pressure Sore N/A
Completed NCT05646121 - Suprasorb® A + Ag in the Treatment of Wounds at Risk of Infection and Infected Wounds
Not yet recruiting NCT06421454 - Clinical Trial for the Evaluation of Melatonin in the Treatment of Pressure Ulcers N/A
Terminated NCT05547191 - Evaluate Efficacy and Safety of ChloraSolv When Treating Pressure Ulcers in Need of Debridement N/A
Completed NCT05458050 - An Investigation to Identify Subjects Admitted to Hospital With an Increased Risk of Developing Pressure Ulcers N/A
Active, not recruiting NCT03048357 - Effectiveness of Freedom Bed Compared to Manual Turning in Prevention of Pressure Injuries in Persons With Limited Mobility Due to Traumatic Brain Injury and/or Spinal Cord Injury. N/A
Completed NCT06025370 - Pressures During Prone Positions in Healthy Volunteers N/A
Recruiting NCT05033470 - A Multicentre Prospective Study Evaluating an Off-loading Mattress Overlay System in Healing of Stage 3 Pressure Ulcers N/A