Condition category
Injury, Occupational Diseases, Poisoning
Date applied
31/10/2017
Date assigned
04/12/2017
Last edited
23/11/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
A pressure ulcer, also known as pressure sore, is a sore that occurs when a high amount of pressure breaks down the skin. Successful pressure ulcer prevention requires focus upon several aspects of care including the identification of risk of pressure damage, assessment and care of the skin, attention to nutrition along with repositioning and pressure redistributing support surface use to reduce mechanical loading of the skin and soft tissues. The 2014 International Pressure Ulcer Guidelines reports upon specific interventions to reduce the likelihood of heel pressure ulcers given the common occurrence of severe pressure ulcers at this anatomical location. In the guidelines focus is placed upon the appropriate use of heel suspension devices that aim to ‘float’ the heel so that no mechanical load (force or pressure) is exerted upon this small surface area. While totally removing load from the heel is recommended this practice was not the only approach to heel pressure ulcer prevention noted in the guidelines with the use of prophylactic dressings at the heel also proposed as an effective strategy. There are a wide range of heel suspension devices and prophylactic dressings that could be used to protect the heel including; pillows, foam cushions, gel pads, multi-layer dressings and heel protector boots made either from foam or with air-filled cells. The limited clinical evidence indicates that the use of heel suspension devices reduced heel ulcer incidence compared with standard care however there were no direct comparisons between alternative heel suspension devices. The aim of this pilot study is to compare the incidence of heel pressure ulcers among orthopaedic in-patients allocated either foam based heel protectors (Prevalon™ Heel Protector, Sage Products Inc) or the standard pressure ulcer prevention used by the ward (SPUP), to both heels while resting in bed.

Who can participate?
Adults aged 18 and older who are vulnerable to developing a pressure ulcer on their feet.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive the prevalon heel protector which they wear for ten days. Those in the second group receive the standard level of care. Participants are followed up to assess the incidence of heel pressure ulcers and compare outcomes in each group.

What are the possible benefits and risks of participating?
There may be no direct benefit to the patient, however the patient will be seen daily by a research nurse and/or research podiatrist who have expertise in the area of pressure injury. Information learned during this study may benefit patients at risk of pressure damage in the future. There are no direct risks with participating.

Where is the study run from?
Welsh Wound Innovation Centre (UK)

When is the study starting and how long is it expected to run for?
May 2015 to December 2018

Who is funding the study?
Sage Products, LLC (under Stryker) (UK)

Who is the main contact?
Mrs Nicola Ivins

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Nicola Ivins

ORCID ID

Contact details

Welsh Wound Innovation Centre
Rhodfa Marics
Ynysmaerdy
Pontyclun
Rhondda Cynon Taf
Wales
Pontyclun
CF72 8UX
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Protocol No WWIC/2016/07

Study information

Scientific title

The incidence of heel pressure ulcers among orthopaedic patients who wear Prevalon boots or alternative heel protection: Exploratory study

Acronym

Study hypothesis

The aim of this study is to investigate the effectiveness of Prevalon Boots when used to prevent heel pressure injury among orthopaedic hospital patients and to determine the effectiveness of the Prevalon Heel Protector in the prevention and resolution of heel pressure damage compared with the Standard Pressure Ulcer Prevention used by the ward.

Ethics approval

Wales REC 4, 14/06/2017, ref: 17/WA/0138

Study design

Pilot randomised controlled single-centre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format. Please contact Nicola Ivins nicky.ivins@wwic.wales to request a patient information sheet.

Condition

Pressure ulcer

Intervention

This is a randomised controlled study (RCT) to investigate the effectiveness of Prevalon Boots when used to prevent heel pressure injury among orthopaedic hospital patients. Willing patients who meet the inclusion and exclusion criteria provide consent and assessed in line with standard care. All prticipants included in the pilot study are randomised to receive either Prevalon boots or standard of care pressure ulcer prevention used by the ward, on an equal basis.

Patients in each arm of the study receive 10 days of treatment and follow-up assessments of their heels. Those who are randomly allocated to receive the Prevalon heel protector group receive the Prevalon Heel protector and wear it on each foot for ten days. Follow-up patient visits are recorded daily. These consist of photographs of both heels and CRF completion.

Intervention type

Device

Phase

Drug names

Primary outcome measure

1. Incidence of new heel pressure damage is measured assessing the surrounding skin from the photographs at baseline,days one, two, three, four, five, six, seven, eight, nine and 10
2. Resolution of category I heel pressure damage is measured conducting an assessment of the surrounding skin using the photograph of the patients heels. The assessor of the photographs will be blinded to the treatment arms of the patients

Secondary outcome measures

1. Patient comfort is measured by asking the patients questions about their experience at baseline (prior to randomization), day five, and day 10
2. Patient acceptance of the heel protectors is measured by asking questions about the patient’s experience at baseline (prior to randomization), day five, and day 10
3. Staff acceptance of the heel protectors is measured by asking questions about the staff’s experience at baseline (prior to randomization), day five, and day 10

Overall trial start date

31/05/2015

Overall trial end date

31/12/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Over 18 years old
2. In-patient within designated orthopaedic ward
3. No visible heel pressure damage of category I heel ulcer only
4. Considered vulnerable to developing pressure ulcers based on pressure ulcer risk assessment score and mobility or activity restrictions
5. Able to provide informed consent
6. No lower limb amputations
7. Ankle-brachial pressure index (ABPI) between 0.8 and 1.3 at baseline

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40

Participant exclusion criteria

1. Under 18 years old
2. Visible heel pressure damage (category II and above)
3. Not at risk of developing pressure ulcers
4. Unable to provide informed consent
5. Lower limb amputation
6. ABPI under 0.8 or above 1.3 at baseline
7. Patients who have participated in a clinical trial on wound healing within the past month
8. Patients with a known history of non-adherence with medical treatment

Recruitment start date

01/11/2017

Recruitment end date

18/10/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Welsh Wound Innovation Centre
Rhodfa Marics Ynysmaerdy Pontyclun Rhondda Cynon Taf Wales
Pontyclun
CF72 8UX
United Kingdom

Sponsor information

Organisation

Sage Products, LLC (now under Stryker)

Sponsor details

3909 Three Oaks Road
Cary Illionois
Cary
60013
United States of America

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Sage Products, LLC (under Stryker)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned to publish the results in a high-impact peer reviewed journal.

IPD sharing statement:
The current data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

30/12/2018

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes