Parafricta Bootees vs UK Standard Care to Prevent Heel Pressure Ulcers

Cardiff and Vale University Health Board31 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Pressure Ulcer Pressure Injury Heel Ulcer

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Incidence of heel pressure ulcers of EPUAP NPUAP/PPPIA Category 1 or above

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.

Time frame: Day 3