The number of heel pressure ulcers amongst patients on an orthopaedic ward who wear Prevalon boots or alternative heel protection over a 10 day period

Completed

• Conditions: Injury, Occupational Diseases, Poisoning; Pressure ulcer

• Registration Number: ISRCTN14788194
• Lead Sponsor: Sage Products, LLC (now under Stryker)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-12-04
• Last Update Posted: 10 December 2018
• Study Completion: 2018-12-31

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 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<br> 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<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Patient comfort is measured by asking the patients questions about their experience at baseline (prior to randomization), day five, and day 10<br> 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<br> 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<br>