Parafricta bootees vs UK standard care to prevent heel pressure ulcers
Research type
Research Study
Full title
Parafricta bootees compared to UK standard care to prevent heel pressure ulcers: a multicentre pragmatic randomised controlled trial with blinded assessment at three days and fourteen days
IRAS ID
213629
Contact name
Grace Carolan-Rees
Contact email
Sponsor organisation
Cardiff and Vale University Local Health Board
Duration of Study in the UK
1 years, 11 months, 26 days
Research summary
Pressure ulcers are a serious problem for people who are bedbound in hospital. They occur due to:
i) Pressure on the skin when there is lack of movement.
ii) Friction and shear to the skin due to repetitive movement.
About 20% of pressure ulcers occur on the heels. Standard preventive care includes a pressure relief mattress and frequent repositioning by nurses. Pillows, foam bootees or inflatable bootees help to protect their feet from damage.
Our study will assess Parafricta bootees. These are designed to protect the feet from friction and shear. Some evidence suggests that the bootees may prevent heel pressure ulcers in hospital patients.
This randomised study will recruit people admitted to hospital who are bedbound or unable to walk independently and needing help to transfer to a chair and at very high risk of pressure ulcers (defined by a Waterlow Pressure Ulcer Risk Score of 20 or more). We will exclude people with heel pressure ulcers at admission and single or double lower limb amputees.
450 participants will be randomly allocated to one of two groups:
Group 1: Parafricta bootees added to standard care (n = 225).
Group 2: Standard care alone (n = 225).
Participants will be assessed for heel pressure ulcers on days 0, 3 and 14. The primary outcome is the number of heel pressure ulcers present at 3 days, determined by independent blind assessment of digital photographs. The secondary outcome measures are:
i) Number of heel pressure ulcers at 14 days.
ii) Length of hospital stay.
iii) Severity of pressure ulcers.
iv) Patient acceptability assessed using a short questionnaire.
v) Cost effectiveness of Parafricta bootees.REC name
Wales REC 7
REC reference
17/WA/0051
Date of REC Opinion
21 Mar 2017
REC opinion
Further Information Favourable Opinion