Back to resultsParafricta Bootees vs UK Standard Care to Prevent Heel Pressure Ulcers
Primary Purpose
Pressure Ulcer, Pressure Injury, Heel Ulcer
Status
Terminated
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Parafricta bootees
Sponsored by
About this trial
This is an interventional prevention trial for Pressure Ulcer focused on measuring Parafricta, Pressure ulcer
Eligibility Criteria
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.
Sites / Locations
- Cedar, Cardiff & Vale University Health Board
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Standard care alone
Parafricta bootees plus standard care
Arm 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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04023981
First Posted
July 16, 2019
Last Updated
July 17, 2019
Sponsor
Cardiff and Vale University Health Board
Collaborators
Welsh Wound Innovation Centre
1. Study Identification
Unique Protocol Identification Number
NCT04023981
Brief Title
Parafricta Bootees vs UK Standard Care to Prevent Heel Pressure Ulcers
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Terminated
Why Stopped
Difficulties in recruiting eligible participants
Study Start Date
October 26, 2017 (Actual)
Primary Completion Date
April 30, 2018 (Actual)
Study Completion Date
April 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cardiff and Vale University Health Board
Collaborators
Welsh Wound Innovation Centre
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pressure Ulcer, Pressure Injury, Heel Ulcer
Keywords
Parafricta, Pressure ulcer
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Assessment of the primary study outcome was by independent blinded assessment of digital photographic images, by assessors who did not undertake study visits and who were unaware of the participant's allocated treatment.
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard care alone
Arm Type
No Intervention
Arm 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.
Arm Title
Parafricta bootees plus standard care
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
Parafricta bootees
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of heel pressure ulcers of EPUAP NPUAP/PPPIA Category 1 or above
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Grace Carolan-Rees, Prof
Organizational Affiliation
Cedar, Cardiff & Vale University Health Board
Official's Role
Study Director
Facility Information:
Facility Name
Cedar, Cardiff & Vale University Health Board
City
Cardiff
ZIP/Postal Code
CF14 4UJ
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Parafricta Bootees vs UK Standard Care to Prevent Heel Pressure Ulcers
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