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Parafricta Bootees vs UK Standard Care to Prevent Heel Pressure Ulcers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04023981
Recruitment Status : Terminated (Difficulties in recruiting eligible participants)
First Posted : July 18, 2019
Last Update Posted : July 18, 2019
Sponsor:
Collaborator:
Welsh Wound Innovation Centre
Information provided by (Responsible Party):
Dr Grace Carolan-Rees, Cardiff and Vale University Health Board

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pressure Ulcer Pressure Injury Heel Ulcer Device: Parafricta bootees Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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.
Primary Purpose: Prevention
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.
Actual Study Start Date : October 26, 2017
Actual Primary Completion Date : April 30, 2018
Actual Study Completion Date : April 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pressure Sores

Arms and Interventions
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Arm Intervention/treatment
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.
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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of heel pressure ulcers of EPUAP NPUAP/PPPIA Category 1 or above [ Time Frame: Day 3 ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04023981


Locations
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United Kingdom
Cedar, Cardiff & Vale University Health Board
Cardiff, United Kingdom, CF14 4UJ
Sponsors and Collaborators
Cardiff and Vale University Health Board
Welsh Wound Innovation Centre
Investigators
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Study Director: Grace Carolan-Rees, Prof Cedar, Cardiff & Vale University Health Board
More Information
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Responsible Party: Dr Grace Carolan-Rees, Professor Grace Carolan-Rees, Cardiff and Vale University Health Board
ClinicalTrials.gov Identifier: NCT04023981    
Other Study ID Numbers: WA/17/0051
First Posted: July 18, 2019    Key Record Dates
Last Update Posted: July 18, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr Grace Carolan-Rees, Cardiff and Vale University Health Board:
Parafricta
Pressure ulcer
Additional relevant MeSH terms:
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Pressure Ulcer
Ulcer
Crush Injuries
Pathologic Processes
 Skin Ulcer
Skin Diseases
Wounds and Injuries