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Parafricta Bootees vs UK Standard Care to Prevent Heel Pressure Ulcers

NCT04023981 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2019-07-18

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Welsh Wound Innovation Centre

    collaborator UNKNOWN

  • Cardiff and Vale University Health Board

    lead OTHER_GOV

Principal Investigators

  • Grace Carolan-Rees, Prof · Cedar, Cardiff & Vale University Health Board

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-26
Primary Completion
2018-04-30
Completion
2018-04-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04023981 on ClinicalTrials.gov