An observational study in Pressure Injuries and Pressure Ulcers, Bedsores, Decubitus Ulcer, sponsored by Nottingham University Hospitals NHS Trust. Recruiting at 1 site in United Kingdom. Per ClinicalTrials.gov, last updated 2025-12-26.
Sponsored by Nottingham University Hospitals NHS Trust · Observational
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:
Research Question/Aim(s): How accurate is the BRADEN-QD in capturing risk of pressure injury (PI) in hospitalised infants and children and young people (CYP) with dark skin tones (DST)? Aim: To evaluate critical gaps in knowledge and evidence by modification (as required) and validation of the BRADEN-QD in hospitalised infants and CYP with DST.
Objectives:
Study Design This is a mixed methods sequential study comprising of two phases; Phase 1 (information gathering) consists of two Work Packages (WPs 1 and 2). WP1: Individual interviews or focus groups with stakeholders to identify further PI risk items not captured from the literature. Interviews will be conducted online, over the telephone or face-to-face according to participant preference. Interviews will be audio recorded and transcribed verbatim.
WP2: Participants from stage 1 are invited to take part in a 60-minute Nominal Group Technique online workshop to rank, according to relevance and importance, the PI risk items identified from stage 1. A modified Delphi technique will be used and items with a consensus of ≥ 70% will be added to the BRADEN-QD to create a modified BRADEN-QD (mBRADEN-QD).
Study Phase 2; A multicentre pyschometric validation approach will be used to assess the accuracy and validity of the original tool (BRADEN-QD) or modified BRADEN-QD tool (mBRADEN-QD), based on Phase 1 findings.
Study Participants Phase 1: WP1 and WP2: Healthcare professionals (HCP), Children and young people (CYP), and parents/ guardians.
Phase 2: Hospitalised CYP with dark skin tone. Planned Size of Sample (if applicable) Phase 1: WP1 total participants 20 (7 CYP, 7 parents/ guardians and 6 HCP). WP2 participants from WP1 will be invited to take part. A minimum of 10 participants required.
Phase 2: A total of 522 participants will be recruited into the study across 10 sites. Each site will be expected to recruit a total of 52 participants.
Follow up duration (if applicable): Phase 2 For participants recruited for Phase 2, PI assessment is to be completed three times per week (Monday, Wednesday and Friday) for two full weeks and then once weekly for two weeks = maximum 8 times total follow up. Subject data will be considered complete at discharge or hospital day 28 after enrolment into the study whichever occur first. Any identified hospital acquired pressure injuries (HAPIs) will be categorised according to stage and causation. HAPIs will be managed at the discretion of the clinical team.
545 studies on the registry are indexed under Pressure Ulcer; 129 are open to participants now.
This study's planned enrollment of 542 is above the median of 138 across 110 observational studies indexed under Pressure Ulcer.
Browse Pressure Ulcer studies →Nottingham University Hospitals NHS Trust is the lead sponsor of 107 studies on the registry; 19 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Phase 1
HCP participants:
Parent/ guardian participants:
CYP participants:
1. Infants and CYP admitted to hospital for 24 hrs 2. Age 0-19 years 3. Able to gain consent. 4. Fitzpatrick Classification of Skin Types IV, V or VI.
Exclusion Criteria:
Phase1:
HCP participants:
Parents participants:
CYP participants:
1. Admitted to hospital for less than 24 hrs 2. Unable to gain consent 3. Fitzpatrick Classification of Skin Types I, II or III
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
Time frame: up to 4 weeks
Pressure Injury development
Developing a pressure injury while in hospital.
Time frame: up to 4 weeks
Length of hospital stay (LOS)
Number of days in hospital
Time frame: up to 24 weeks
Morbidity
Complications experienced while in hospital
Time frame: Up to 4 weeks
Mortality
Deaths while in hospital
Time frame: up to 4 weeks
Economic impact
Estimated treatment costs from pressure injury
Time frame: Up to 4 weeks
Plan to share: Undecided
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