Heel protection for pressure ulcer prevention: from prehospital patient care to discharge

ISRCTN ISRCTN85296908
DOI https://doi.org/10.1186/ISRCTN85296908
Secondary identifying numbers N/A
Submission date
12/03/2013
Registration date
22/04/2013
Last edited
17/12/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Skin and Connective Tissue Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr Asa Muntlin Athlin
Scientific

Department of Emergency Care
Uppsala University Hospital
S-751 85 Uppsala
Sweden
Uppsala
75185
Sweden

Email asa.muntlin@pubcare.uu.se

Study information

Study designMulticentre randomised controlled intervention study. Block-randomisation according to study sites and sample groups.
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typePrevention
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleHeel protection for pressure ulcer prevention: from prehospital patient care to discharge. A randomized controlled trial in two county councils in Sweden.
Study objectivesThe 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(s)Regional Ethical Review Board, Uppsala, Sweden. Dnr 2011/049
Health condition(s) or problem(s) studiedHeel pressure ulcers
InterventionIntervention: 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 typeOther
Primary outcome measureIncidence 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 measuresAt 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 study start date01/05/2011
Completion date30/04/2013

Eligibility

Participant type(s)Patient
Age groupSenior
SexBoth
Target number of participants304
Key inclusion criteria1. 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
Key exclusion criteriaPatients in need of life-saving treatment
Date of first enrolment01/05/2011
Date of final enrolment30/04/2013

Locations

Countries of recruitment

  • Sweden

Study participating centre

Department of Emergency Care
Uppsala
75185
Sweden

Sponsor information

Etac Sverige AB (Sweden)
Industry

Box 203
Anderstorp
33424
Sweden

Phone +46 (0)371 58 73 00
Email info@etac.se
Website http://www.etac.com

Funders

Funder type

Research council

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

No information available

Uppsala County Council (Sweden) ref: LUL- 191821

No information available

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 14/11/2016 17/12/2020 Yes No

Editorial Notes

17/12/2020: Publication reference added.