Parafricta Bootees vs UK Standard Care to Prevent Heel Pressure Ulcers

Cardiff and Vale University Health Board

Status: Terminated

Conditions: Heel Ulcer; Pressure Ulcer; Pressure Injury

Treatments: Device: Parafricta bootees

Study type: Interventional

Funder types: Other

Identifiers

NCT04023981

WA/17/0051

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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31 participants in 2 patient groups

Standard care alone

No Intervention group

Description:

Patients randomly allocated to standard care will be cared for on the appropriate mattress indicated for use in that participating centre according to local policy e.g. foam mattress or dynamic air mattress. Standard care may also include a mattress overlay or the use of a wedge or pillows to maintain the position of the participant, or pressure offloading boots on the foot if the need arises during the study period.

Parafricta bootees plus standard care

Experimental group

Description:

Patients randomly allocated to Parafricta plus standard care will be cared for on the appropriate mattress as above and care may possibly include a mattress overlay or the use of a wedge or pillows. Participants will in addition be issued with Parafricta bootees (one pair and up to two spare pairs). The patient and clinical staff and the patient's carers will be instructed in the use of Parafricta bootees, which are intended to be worn throughout the day and night and removed only for normal daily washing or examination of the patient's feet. Either the slip-on bootees or the Velco-closure bootees will be selected for the participant at the judgment of the clinical ward nurses.

Treatment:

Device: Parafricta bootees