Parafricta Bootees vs UK Standard Care to Prevent Heel Pressure Ulcers
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|ClinicalTrials.gov Identifier: NCT04023981|
Recruitment Status : Terminated (Difficulties in recruiting eligible participants)
First Posted : July 18, 2019
Last Update Posted : July 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pressure Ulcer Pressure Injury Heel Ulcer||Device: Parafricta bootees||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|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.|
|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|
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.
- 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.
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
|Cedar, Cardiff & Vale University Health Board|
|Cardiff, United Kingdom, CF14 4UJ|
|Study Director:||Grace Carolan-Rees, Prof||Cedar, Cardiff & Vale University Health Board|