Parafricta Bootees vs UK Standard Care to Prevent Heel Pressure Ulcers

NCT04023981 | Terminated

• 1 other identifier: WA/17/0051
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Pressure Ulcer; Pressure Injury; Heel Ulcer

Keywords

Parafricta; Pressure ulcer

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 3

Study Arms (2)

Standard care alone

NO INTERVENTION

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.

Parafricta bootees plus standard care

EXPERIMENTAL

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

Interventions

Parafricta bootees DEVICE

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.

Parafricta bootees plus standard care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients with a single or double lower limb amputation were not eligible to participate in the study.

Sponsors & Collaborators

• Cardiff and Vale University Health Board: lead
• Welsh Wound Innovation Centre: collaborator

Study Sites (1)

Cedar, Cardiff & Vale University Health Board

Cardiff, CF14 4UJ, United Kingdom

Location

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Grace Carolan-Rees, Prof

  Cedar, Cardiff & Vale University Health Board

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Grace Carolan-Rees

Study Record Dates

• First Submitted: July 16, 2019
• First Posted: July 18, 2019
• Study Start: October 26, 2017
• Primary Completion: April 30, 2018
• Study Completion: April 30, 2018
• Last Updated: July 18, 2019

Record last verified: 2019-07

Locations

GB (1)