None listed
Conditions
Brief summary
This is a multisite single-blinded randomised controlled trial of 418 patients across three intensive care units in three acute hospitals to evaluate the clinical effectiveness of a heel off-loading boot (Prevalon TM) in reducing heel pressure injuries and preventing foot contractures in intensive care patients. Patients in ICU who meet the eligibility criteria will be allocated to one of two arms, either the intervention (PrevalonTM heel protector boot - https://sageproducts.com/prevalon-heel-protectors/) or the control (standard care - use of pillow/s for heel elevation). The trial design follows the Consolidated Standards of reporting Trials (CONSORT) protocol RCTs. Our hypothesis is patients who receive the intervention have a lower incidence of heel PIs and plantar flexion contractures compared to those patients who have standard care. The planned duration of this study is 18 months.
Interventions
The intervention will consist of the application of the PrevalonTM heel protector boot; Skin inspection to the heels every 8 hours; Shift by shift assessment of the PrevalonTM heel protector boot position; Documentation of all assessment and prevention strategies at each shift. The boot will remain insitu for the duration of the patient’s intensive care unit stay or until the patient is no longer bed-bound and no longer deemed at risk of developing a heel pressure injury.
The PrevalonTM boot is
The intervention will consist of the application of the PrevalonTM heel protector boot; Skin inspection to the heels every 8 hours; Shift by shift assessment of the PrevalonTM heel protector boot position; Documentation of all assessment and prevention strategies at each shift. The boot will remain insitu for the duration of the patient’s intensive care unit stay or until the patient is no longer bed-bound and no longer deemed at risk of developing a heel pressure injury. The PrevalonTM boot is a heel protector device that supports the foot and ankle and elevates the heel to provide complete off-loading at the heel. The PrevalonTM boot also holds the foot in position to avoid foot and leg rotation to prevent foot contractures. Following ethical and governance approvals, Clinical Nurse Educators, Clinical Nurse Specialists and bedside RNs will be trained in the application of the PrevalonTM heel protector boot and data collection. This training will be provided by the investigators who are all recognised clinical experts. Training comprises one x 30 minute education session on theory, demonstration, procedures and benefits of the PrevalonTM and a 2 minute video on the application of the PrevalonTM. All training will be provided face to face to nurses, either at the bedside at an appropriate time that will be arranged with the nursing unit manager and the clinical nurse educators. The video link is as follows: https://sageproducts.com/videos/heel-protector3/training/. Further, general project information sessions will be provided at each participating hospital site for all ICU clinicians. For patients randomised to the intervention group, a PrevalonTM heel protector boot information brochure (a readily available resource https://sageproducts.com/wp-content/uploads/2015/08/Prevalon-Heel-Protector-Wedge_21433C.pdf) will be left at the bedside for nurses and interested family members. Fidelity and adherence to the intervention and control will be monitored by measurement of processes of care for both groups via a checklist. RNs will complete a checklist to monitor adherence to each group’s protocol (paper or electronic) three times a week.
Sponsors
Royal Prince Alfred Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• All ICU patients >18years with who have been assessed as high risk of developing a pressure injury (Waterlow > 15, Braden <10). • Patients who are expected to remain in ICU > 72 hours • Patients who are expected to be bed bound for at least three days
Exclusion criteria
• Patients with a community or hospital-acquired PI on both heels diagnosed within 24 hours of admission to the ICU.
Outcome results
None listed