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ISRCTN
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ISRCTN78646179
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ClinicalTrials.gov identifier
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Public title
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Randomised controlled trial comparing alternating pressure overlays with alternating pressure mattresses for pressure sore prevention and treatment
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Scientific title
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Acronym
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PRESSURE
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Serial number at source
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HTA 97/06/14
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Study hypothesis
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The project will test the null hypothesis that there is no difference in clinical and cost-effectiveness between Alternating pressure Overlays (AO) and Alternating pressure mattress Replacements (AR).
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Lay summary
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Ethics approval
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Ethics approval information added as of 20/07/2007: This study was approved by the North West Multicentre Research Ethics Committee and Local Ethics Committees.
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Study design
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Multicentre randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Pressure sores
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Participants - inclusion criteria
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Patients aged > 55 years who are admitted to a vascular, orthopaedic or care of the elderly ward with an expected length of stay of at least 7 days AND who are completely immobile/have very limited mobility on admission; or have a pre-existing grade 1, 2 or 3 pressure sore on admission. Patients admitted before elective surgery who are expected to be completely immobile/have very limited mobility for at least 3 days after surgery may also be included.
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Participants - exclusion criteria
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Patients who have a pre-existing grade 4 or 5 pressure sore on admission, have participated in this trial previously or are unable/unwilling to give full informed consent.
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Anticipated start date
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01/05/2000
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Anticipated end date
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31/10/2004
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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1,972
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Interventions
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Patients at moderate to high risk of developing a pressure sore will be randomised (stratified, 24 hour telephone) to either:
1. An Alternating-pressure Replacement mattress (AR)
2. An Alternating pressure mattress Overlay (AO)
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Primary outcome measure(s)
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The occurrence of a first or new sore at or above the level of superficial damage to the skin (break/blister) before discharge will be considered as a treatment failure.
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Secondary outcome measure(s)
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1. Worsening/healing of existing sores
2. Patients' perceptions
3. Time to occurrence
4. Site of sore
5. Economic costs including those incurred in the treatment of pressure sores in the community, post-discharge
Skin assessments will be made daily by qualified attendant nursing staff and validated twice weekly by research nurses.
Health economic results comparing the costs and benefits of the expensive with the cheaper mattresses, will be expressed as incremental cost effectiveness ratios.
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Sources of funding
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NIHR Health Technology Assessment Programme - HTA (UK)
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Trial website
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Publications
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2006 results in: http://www.ncbi.nlm.nih.gov/pubmed/16740530
2006 cost-effectiveness analysis in: http://www.ncbi.nlm.nih.gov/pubmed/16740528
2006 HTA monograph: http://www.ncbi.nlm.nih.gov/pubmed/16750060
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Contact name
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Dr
Nicky
Cullum
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Address
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Department of Health Sciences
University of York
Alcuin College
Area 2
Seebohm Rowntree Building
Heslington
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City/town
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York
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Zip/Postcode
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YO10 5DD
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Country
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United Kingdom
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Tel
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+44 (0)1904 321343
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Fax
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+44 (0)1904 321383
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Email
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nac2@york.ac.uk
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Sponsor
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Department of Health (UK)
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Address
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Quarry House
Quarry Hill
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City/town
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Leeds
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Zip/Postcode
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LS2 7UE
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Country
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United Kingdom
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Tel
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+44 (0)1132 545 843
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Email
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Sheila.Greener@doh.gsi.gov.uk
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Sponsor website:
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http://www.dh.gov.uk/en/index.htm
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Date applied
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25/04/2003
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Last edited
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26/08/2009
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Date ISRCTN assigned
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25/04/2003
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