Condition category
Skin and Connective Tissue Diseases
Date applied
12/03/2013
Date assigned
22/04/2013
Last edited
22/04/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Since 2007, patient safety issues which include pressure ulcers prevention are on top of the Swedish healthcare’s agenda. Research has shown that the incidence of hospital-acquired pressure ulcers on the sacrum (the large bone at the base of the spinal cord) has decreased, probably due to the increase of use of pressure ulcers prevention mattresses. However, the incidence of hospital-acquired pressure ulcers on the heels is still present.
Pressure ulcers cause suffering for the patient and considerable costs for health care. Pressure damage can occur quickly (within hours), depending on the individual patient's risk factors and it is important that preventive actions will start as soon as possible. That can already start in ambulances. Ambulances in Sweden are equipped with conventional stretchers (without pressure relief function) and the length of transport may vary from a few minutes and hours. No study, either international or national, has been done on the development of pressure ulcers across the continuum of care, from the ambulance to the hospital. To our knowledge, no research has so far identified the best method to prevent this kind of pressure ulcers. The aim of the study is to investigate the effects of an early treatment (Heelift – heel pressure ulcers prevention boot) on hospital-acquired heel pressure ulcers.

Who can participate?
Patients over 70 years of age, with neurological symptoms or reduced general condition, transferred by ambulance to the emergency department will be invited to participate in this study.

What does the study involve?
Patients will be randomly allocated to one of two groups: the intervention group or the control group.
Patients in the intervention group will receive a heel pressure ulcers prevention boot on both heels. This prevention boot will be used during the whole hospital stay (emergency department, ward). At the end of the hospital stay, the patients will be asked to evaluate the use of the prevention boot, regarding usefulness, comfort and acceptance. Patients in the control group will receive standard pressure ulcers prevention care. Both groups of patients will have their heels assessed for pressure ulcers regularly.

What are the possible benefits and risks of participating?
The patient's level of risk for development of pressure ulcers will be assessed. Patients will also have their heels assessed for pressure ulcers regularly during their hospital stay. These assessments will take place in the ambulance, in the emergency department and throughout the entire hospital stay.
There will no risks to the patients. Participation in this study will not delay any need of medical care.

Where is the study run from?
The study is run from the following study sites: the ambulance care in Uppsala County Council, Uppsala University Hospital, the ambulance care in County Council of Värmland and Karlstad Central Hospital (Sweden).

When is the study starting and how long is it expected to run for?
The study started in May 2011 and is expected to be finished in April 2013.

Who is funding the project?
This study is funded by Uppsala University Hospital, Karlstad University, Uppsala County Council, Varmland County Council and Uppsala-Örebro Regional Research Council (Sweden).

Who is the main contact?
Principal Investigator: Asa Muntlin Athlin, asa.muntlin@pubcare.uu.se
Research Site Manager, County Council of Värmland: Carina Baath

Trial website

Contact information

Type

Scientific

Primary contact

Dr Asa Muntlin Athlin

ORCID ID

Contact details

Department of Emergency Care
Uppsala University Hospital
S-751 85 Uppsala
Sweden
Uppsala
75185
Sweden
asa.muntlin@pubcare.uu.se

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Heel protection for pressure ulcer prevention: from prehospital patient care to discharge. A randomized controlled trial in two county councils in Sweden.

Acronym

Study hypothesis

The overall aim of the study is to investigate the effects of an early intervention (Heelift) on incidence of hospital-acquired heel pressure ulcers.

Research questions:
1. What are the effects of an early intervention (Heelift – heel pressure ulcers prevention boot) on incidence of hospital-acquired heel pressure ulcers?
2. Which predictors for heel pressure ulcers can be determined?
3. How do patients perceive the use of the Heelift heel pressure ulcer prevention boot, regarding usefulness, comfort and acceptance?

The hypothesis is that an early intervention, the use of Heelift heel pressure ulcers prevention boot, decrease the incidence of hospital-acquired heel pressure ulcers compared to standard care.

Ethics approval

Regional Ethical Review Board, Uppsala, Sweden. Dnr 2011/049

Study design

Multicentre randomised controlled intervention study. Block-randomisation according to study sites and sample groups.

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 use the contact details below to request a patient information sheet

Condition

Heel pressure ulcers

Intervention

Intervention: Heelift – heel pressure ulcers prevention boot. Regularly pressure ulcer assessments and risk assessments. Time: From prehospital care to discharge.

Control: standard care regarding prevention of pressure ulcers. Regularly pressure ulcer assessments and risk assessments. Time: From prehospital care to discharge.

Follow-up: In the event of an in-hospital acquired heel pressure ulcer, assessment and treatment of the heel pressure ulcer will be recorded until healing.

Joint/Scientific contact details:
Carina Baath
Faculty of Health, Science and Technology
Department of Health Sciences
S-651 88 Karlstad
Sweden
+46 54 7002089
carina.baath@kau.se

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Incidence of hospital-acquired heel pressure ulcers, classified according to European Pressure Ulcer Advisory Panel (EPUAP), category 1-4 (1= Non-blanchable redness of intact skin, 4= Full thickness tissue loss (muscle/bone visible).

Secondary outcome measures

At discharge:
1. Patient’s perceptions of using Heelift, regarding usefulness and comfort. Measurement: Yes/No/Cannot tell
2. Patient’s perceptions of acceptance of using Heelift. Measurement: Yes/No/Cannot tell

Overall trial start date

01/05/2011

Overall trial end date

30/04/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients from the County Council of Uppsala admitted to Uppsala University Hospital (Sweden) and patients from the County Council of Varmland admitted to Karlstad General Hospital (Sweden) will be included in the study.
2. Male/female patients, over 70 years of age
3. With neurological symptoms or reduced general condition transferred with ambulance to the emergency department

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

304

Participant exclusion criteria

Patients in need of life-saving treatment

Recruitment start date

01/05/2011

Recruitment end date

30/04/2013

Locations

Countries of recruitment

Sweden

Trial participating centre

Department of Emergency Care
Uppsala
75185
Sweden

Sponsor information

Organisation

Etac Sverige AB (Sweden)

Sponsor details

Box 203
Anderstorp
33424
Sweden
+46 (0)371 58 73 00
info@etac.se

Sponsor type

Industry

Website

http://www.etac.com

Funders

Funder type

Research council

Funder name

Uppsala-Örebro Regional Research Council (Sweden) ref: RFR-218661, RFR-138231

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Uppsala County Council (Sweden) ref: LUL- 191821

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Karlstad County Council (Sweden) ref: LIV FOU 214811, LIV FOU 169261

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes