NCT04023981

Parafricta Bootees vs UK Standard Care to Prevent Heel Pressure Ulcers

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 at Fourteen Days.

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Cardiff and Vale University Health Board · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pressure Ulcer
• Pressure Injury
• Heel Ulcer

Interventions

Type	Name	Description
DEVICE	Parafricta 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.

Timeline

• Start date: 2017-10-26
• Primary completion: 2018-04-30
• Completion: 2018-04-30
• First posted: 2019-07-18
• Last updated: 2019-07-18

Locations

1 site across 1 country: United Kingdom