WHITE-PRESSURE3: World Hip Trauma Evaluation - Pressure ulcer prevention 3; A randomised clinical trial assessing early heel specific adjunct devices for heel pressure ulcer prevention in people with a fractured hip.
Every year, thousands of hip fracture patients in the UK develop painful heel pressure ulcers that delay their recovery and discharge from hospital. These ulcers—open wounds caused by prolonged pressure on the heel—can become infected, require additional treatment, and keep patients bedbound longer. Current standard care uses high-specification mattresses and frequent repositioning, but many patients still develop Category 2 or higher ulcers. Heel-specific devices that either completely lift the heel off the bed or distribute pressure over a larger area are available in the NHS but are not routinely used, even in high-risk patients. This trial will randomise 3,102 hip fracture patients aged 60 or over across 30 UK hospitals to receive either standard care alone, standard care plus a heel off-loading device, or standard care plus a constant low pressure device. The primary outcome is the proportion of patients who develop a new Category 2 or higher heel ulcer within 30 days of diagnosis. An embedded economic evaluation will assess cost-effectiveness against NICE standards. If one or both devices prove effective, the NHS could adopt a simple, low-cost intervention that prevents painful complications, shortens hospital stays, and helps older people regain their independence faster.
View original technical description
Patients admitted with a fractured hip are at risk of heel pressure ulcers (PU) which impact upon rehabilitation, recovery and independence. Whilst available in the NHS, the use of heel specific adjunct devices for heel PU prevention is not common, even in high-risk patient populations. AIM: to evaluate the clinical and cost-effectiveness of the use of early initiation of heel off-loading devices and constant low pressure devices for the prevention of Category 2 or higher heel PUs in hip fractures patients. PRIMARY OBJECTIVE: To compare the incidence of new Category 2 or higher heel PUs from diagnosis of a hip fracture to index hospital discharge or 30 days which ever is soonest, between Standard Care plus early initiation of a Heel Off-loading Device, Standard Care plus early initiation of a CLP Device and Standard Care alone in patients with hip fracture. SECONDARY OBJECTIVES: will compare: 1. the incidence of new Category 1 heel PUs from randomisation to index hospital discharge or 30 days which ever is soonest between treatment groups in participants with intact skin at randomisation. 2. the overall incidence of new Category 1 or higher heel PUs from randomisation to index hospital discharge or 30 days which ever is soonest, between treatment groups in participants with intact skin at randomisation. 3. the progression of Category 1 or higher heel PUs to a higher Category from diagnosis of a hip fracture to index hospital discharge or 30 days which ever is soonest. 4. the proportion of resolved heel PUs at 4 months post-diagnosis of a hip fracture between treatment groups in participants with a Category 1 or higher heel PU at their final pre-discharge/30 day in-hospital skin status assessment. 5.To quantify the comparative cost effectiveness of the trial treatments up to 12 months post-randomisation. DESIGN: pragmatic, multi-centre, randomised, 3 arm parallel group trial with embedded economic evaluation and internal pilot. SETTING: the trial will be embedded within the World Hip Trauma Evaluation (WHiTE) Platform in 30 pre-established WHiTE centres. Existing ethical and regulatory approvals for the platform enable efficiencies in study set-up. TARGET POPULATION: aged 60 years or over, admitted with a fracture of the hip within previous 48 hours. Excusions include pre-existing PU HEALTH TECHNOLOGIES: 3102 patients (1034 per group) will be randomised to: a) Standard of care plus adjunct heel off-loading devices which completely eliminate heel pressure including heel lift/suspension boots and off-loading wedges b) Standard of care plus adjunct constant low pressure device which distribute pressure over a larger surface area and so reduce the magnitude of the applied pressure including foam and gel pads and boots c) standard care alone which typically includes the provision of high specification foam mattresses or specialised air mattress; an electric profiling bed and; repositioning more frequently than 3 hourly. ANALYSES: analysis will be on an intention to treat basis with proportions of new Category 2 and higher heel PUs reported for each group and for the two principal comparisons: heel offloading versus standard care and CLP versus standard care, odds ratios and 97.5% confidence intervals will be reported. The economic assessment methods will adhere to the recommendations of the National Institute for Health and Care Excellence (NICE) Reference Case. TIMELINES AND ACCRUALS: Total 36 months – set-up 5months under WHiTE Platform, 6 month internal pilot in 6 centres, with 15 months full recruitment in 24 additional centres, 5 months follow-up and 5 months analysis/HTA monograph. IMPACT AND DISSEMINATION: the trial will provide definitive evidence on the effectiveness of adjunct devices for the prevention of heel PUs. We have developed a comprehensive publication, dissemination and impact plan to ensure implementation in clinical practice
Plain English summaries and category classifications on this site are generated by AI and may not perfectly reflect the original research.
Is something wrong? Let us know