Parafricta Bootees vs UK Standard Care to Prevent Heel Pressure Ulcers

• ClinicalTrials.gov Identifier: NCT04023981
• Recruitment Status: Terminated
• First Posted: July 18, 2019
• Last Update Posted: July 18, 2019
• Sponsor: Cardiff and Vale University Health Board
• Collaborator: Welsh Wound Innovation Centre
• Information provided by (Responsible Party): Dr Grace Carolan-Rees, Cardiff and Vale University Health Board

Tracking Information

• First Submitted Date: July 16, 2019
• First Posted Date: July 18, 2019
• Last Update Posted Date: July 18, 2019
• Actual Study Start Date: October 26, 2017
• Actual Primary Completion Date: April 30, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 17, 2019)

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.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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.
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

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

Condition

• Pressure Ulcer
• Pressure Injury
• Heel Ulcer

Intervention

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.

Study Arms

• 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.
  Intervention: Device: Parafricta bootees

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: July 17, 2019): 31
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: April 30, 2018
• Actual Primary Completion Date: April 30, 2018 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT04023981
• Other Study ID Numbers: WA/17/0051
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Dr Grace Carolan-Rees, Cardiff and Vale University Health Board
• Original Responsible Party: Same as current
• Current Study Sponsor: Cardiff and Vale University Health Board
• Original Study Sponsor: Same as current
• Collaborators: Welsh Wound Innovation Centre

Investigators

• Study Director: Grace Carolan-Rees, Prof; Cedar, Cardiff & Vale University Health Board

• PRS Account: Cardiff and Vale University Health Board
• Verification Date: July 2019