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Randomised controlled trial comparing alternating pressure overlays with alternating pressure mattresses for pressure sore prevention and treatment
DOI 10.1186/ISRCTN78646179
ClinicalTrials.gov identifier
EudraCT number
Public title Randomised controlled trial comparing alternating pressure overlays with alternating pressure mattresses for pressure sore prevention and treatment
Scientific title
Serial number at source HTA 97/06/14
Study hypothesis 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).
Lay summary
Ethics approval 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.
Study design Multicentre randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Pressure sores
Participants - inclusion criteria 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.
Participants - exclusion criteria 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.
Anticipated start date 01/05/2000
Anticipated end date 31/10/2004
Status of trial Completed
Patient information material
Target number of participants 1,972
Interventions 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)
Primary outcome measure(s) 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.
Secondary outcome measure(s) 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.
Sources of funding NIHR Health Technology Assessment Programme - HTA (UK)
Trial website
Publications 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
Contact name Dr  Nicky  Cullum
  Address Department of Health Sciences
University of York
Alcuin College
Area 2
Seebohm Rowntree Building
  City/town York
  Zip/Postcode YO10 5DD
  Country United Kingdom
  Tel +44 (0)1904 321343
  Fax +44 (0)1904 321383
  Email nac2@york.ac.uk
Sponsor Department of Health (UK)
  Address Quarry House
Quarry Hill
  City/town Leeds
  Zip/Postcode LS2 7UE
  Country United Kingdom
  Tel +44 (0)1132 545 843
  Email Sheila.Greener@doh.gsi.gov.uk
  Sponsor website: http://www.dh.gov.uk/en/index.htm
Date applied 25/04/2003
Last edited 26/08/2009
Date ISRCTN assigned 25/04/2003
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