Heel Ulcer, Pressure Injury, Pressure Ulcer
Conditions
Keywords
Parafricta, Pressure ulcer
Brief summary
This randomised study will assess whether Parafricta bootees, when used in addition to normal standard care, can reduce the incidence of heel PUs in patients at very high risk of skin breakdown. The participant group will be hospital inpatients at high risk of PUs (Waterlow score of 20 or more) who are bedbound and do not have existing heel PUs. The participants will be randomised to an intervention arm using Parafricta plus standard care, or a control arm of standard care only. The primary outcome is incidence of heel PUs at day 3. Secondary outcomes are incidence of PUs at day 14, length of stay, severity of PUs, patient acceptability of device, cost-effectiveness.
Interventions
DEVICEParafricta bootees
Parafricta bootees are a medical device designed to eliminate skin damage due to friction and shear. The basis of Parafricta bootees is a low friction material and bi-layer construction to make the material of the bootee slide on itself when movement of the foot would otherwise bring friction and shear to bear on the skin.
Sponsors
Welsh Wound Innovation Centre
Cardiff and Vale University Health Board
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
Assessment of the primary study outcome was by independent blinded assessment of digital photographic images, by assessors who did not undertake study visits and who were unaware of the participant's allocated treatment.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
The eligibility criteria for this study at the time of recruitment were: * Adult of age 18 years or over * Admitted to secondary care in an in-patient hospital (with no specified interval from admission to hospital to study recruitment) * Bedbound or unable to walk independently and requiring assistance to transfer to a chair * 'Very high' risk group for pressure ulceration (defined by a Waterlow Score of 20 or more) * No existing heel pressure ulcers of EPUAP/NPUAP/PPPIA Category 1 or above or any other type of wound on the feet. * Patient was not being treated with pressure offloading boots. * Patient was not being treated with a heel cast.
Exclusion criteria
• Patients with a single or double lower limb amputation were not eligible to participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of heel pressure ulcers of EPUAP NPUAP/PPPIA Category 1 or above | Day 3 | Incidence of heel pressure ulcers of EPUAP NPUAP/PPPIA Category 1 or above on Visit 2 (Day 3), assessed by examination of digital images by two independent expert assessors who are blinded to the participants' allocated treatment. |
Countries
United Kingdom
Outcome results
None listed