About this trial
What is the problem? Children and young people admitted to hospital can sometimes be harmed by what is called a pressure injury. Pressure injuries are sores (ulcers) that happen on areas of the skin that are under pressure. The pressure can come from lying in bed, sitting in a wheelchair, or wearing a cast for a long time. They usually form on bony parts of the body, such as the heels, elbows, hips, and tailbone. This can be uncomfortable for the patient and distressing for their families. As well, it means that more staff and treatments are needed for the patient.
What is known? There is a difference in pressure injury seriousness for infants and children with dark skin tones to those without. Pressure injury care for hospitalised patients starts with an assessment using a tool. In the past, the assessment tools were developed without consideration for differences due to skin tone. This means that the current tools may not be the best way to identify pressure injury for dark skin tones. Healthcare professionals need to make sure that tools are fit for purpose for all.
What are investigators going to do? Investigators will work with healthcare professionals, children, and parents together to develop and test the existing pressure injury risk assessment tool for use with dark skin tones.
This study is a result of care priority discussions with parents and children. It came from the patients and will benefit the patients. Children, young people, and parents will be involved throughout to ensure their voices are heard.
How are investigators going to do it?
Investigators will:
1. Look at existing information about pressure injury for children with darker skin tones. If required, investigators will change and increase the accuracy of the existing tool. 2. Test the modified risk assessment tool at 10 children's hospitals in the UK. Investigators will do this to see if it can distinguish hospitalised children with dark skin tones, at high or low risk of pressure injury development during their hospital stay.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Experts (e.g. tissue viability practitioners, dermatologist)
HCP looking after hospitalised infants and CYP
Able to give consent
Parents/ guardians of infants and CYP admitted to hospital with or developed PI
Disqualifiers
HCP not working with hospitalised infants and CYP.
Unable to provide consent.
Parents of hospitalised infants and CYP with no PI.
Unable to gain consent
Trial population
Phase 1: Healthcare professionals who look after infants, children and young people in hospital (children's nurses and doctors from various clinical areas, dermatologist, tissue viability practitioners and clinical educators); parents/ guardians of children who have a dark skin tone, have developed a pressure injury(s) while in hospital before, and children and young people with dark skin tones who have developed pressure injury(s) while in hospital before. Phase 2: Children and young people with dark skin tone admitted to hospital.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Total PI risk assessment score measured using the BRADEN-QD scale with or without additional items
Total PI risk assessment score. The scale uses a 0 to 20 point scale, with scores of 13 or higher indicating a patient is at risk for a PI
Pressure Injury development
Developing a pressure injury while in hospital.
Secondary outcomes
Length of hospital stay (LOS)
Number of days in hospital
Morbidity
Complications experienced while in hospital
Mortality
Deaths while in hospital
Economic impact
Estimated treatment costs from pressure injury
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Nottingham University Hospitals NHS Trust
Lead sponsor
University of Leicester
Collaborator
University of Surrey
Collaborator