World Hip Trauma Evaluation Appendix 14 - 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 (PRESSURE 3)
Prevention of heel pressure ulcer after surgery for a broken hip
WHiTE 14-PRESSURE 3 is a randomised comparison appended to the World Hip Trauma Evaluation (WHiTE ) Platform. WHiTE is a platform trial designed to efficiently deliver multiple randomised comparisons of interventions for patients aged 60 years and over with a hip fracture. The platform and its appended randomised comparisons are governed by one single set of ethical and regulatory approvals and an explicit legal basis and processing purpose for the use of patient-level data. The Platform affords a common core dataset and documentation. Individual randomised comparisons are not dependent on each other and each will have unique start and stop dates and publication of results without compromising the integrity of the platform. Specifically for WHiTE 14-PRESSURE 3: randomisation will be on a 1:1:1 basis stratified by recruitment centre, consent type (individual versus consultee), and skin status at randomisation (Skin Status ‘(0 or A versus Category 1 PU or suspected deep tissue injury)’) using a minimisation algorithm (including a small number to seed the algorithm and a random element) ensuring allocation concealment to the point of randomisation to: * Standard Care plus Constant Low-Pressure Devices for up to 30 days or index hospital discharge (whichever is sooner). Constant Low-Pressure devices distribute pressure over a larger surface area and reduce the magnitude of the applied pressure by increasing the overall contact area *Standard Care plus Heel Off-loading Devices for up to 30 days or index hospital discharge (whichever is sooner). Off-loading devices completely eliminate heel pressure *Standard Care: In this pragmatic randomised comparison, any interventions prescribed for the prevention of PUs to participants in the standard care group will be at the discretion of the attending clinical team. Records will be made of the type of mattress and additional heel adjuvant devices each participant has been assigned pre-randomisation.
Current key inclusion criteria as of 05/06/2026: Platform inclusion criteria: Aged 60 years old and over presenting to a WHiTE recruitment centre for treatment of a hip fracture Additional inclusion criteria for PRESSURE 3: 1. Randomisation occurs within 4 days of diagnosis of a hip fracture 2. In the opinion of the treating clinical team, the patient may benefit from surgical treatment Previous key inclusion criteria: Platform inclusion criteria: Aged 60 years old and over presenting to a WHiTE recruitment centre for treatment of a hip fracture Additional inclusion criteria for PRESSURE 3: 1. Diagnosis of hip fracture within 48 hours of randomisation 2. In the opinion of the treating clinical team, the patient may benefit from surgical treatment
Platform exclusion criteria: 1. Previous participation in the same randomised comparison 2. A second hip fracture (on the other side), while the patient is still enrolled in the Platform following their first hip fracture, Additional exclusion criteria for PRESSURE 3: 3. A heel off-loading or CLP device has been assigned prior to randomisation 4. There is an existing Category 2-4 or Unstageable PU on either heel or ’not applicable' on both heels (ie no evaluable heel sites) 5. There is a contra-indication to the interventions e.g. allergy to device material