- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04023981
Parafricta Bootees vs UK Standard Care to Prevent Heel Pressure Ulcers
July 17, 2019 updated by: Dr Grace Carolan-Rees, Cardiff and Vale University Health Board
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.
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 Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
31
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Cardiff, United Kingdom, CF14 4UJ
- Cedar, Cardiff & Vale University Health Board
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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No Intervention: Standard care alone
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.
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Experimental: Parafricta bootees plus standard care
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of heel pressure ulcers of EPUAP NPUAP/PPPIA Category 1 or above
Time Frame: Day 3
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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.
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Day 3
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Director: Grace Carolan-Rees, Prof, Cedar, Cardiff & Vale University Health Board
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 26, 2017
Primary Completion (Actual)
April 30, 2018
Study Completion (Actual)
April 30, 2018
Study Registration Dates
First Submitted
July 16, 2019
First Submitted That Met QC Criteria
July 17, 2019
First Posted (Actual)
July 18, 2019
Study Record Updates
Last Update Posted (Actual)
July 18, 2019
Last Update Submitted That Met QC Criteria
July 17, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- WA/17/0051
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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