Contact information
Type
Scientific
Primary contact
Dr Nicky Cullum
ORCID ID
Contact details
Department of Health Sciences
University of York
Alcuin College
Area 2
Seebohm Rowntree Building
Heslington
York
YO10 5DD
United Kingdom
+44 (0)1904 321343
nac2@york.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HTA 97/06/14
Study information
Scientific title
Acronym
PRESSURE
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).
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Prevention
Patient information sheet
Condition
Pressure sores
Intervention
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)
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
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 measures
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.
Overall trial start date
01/05/2000
Overall trial end date
31/10/2004
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
1,972
Participant 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.
Recruitment start date
01/05/2000
Recruitment end date
31/10/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Health Sciences
York
YO10 5DD
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
+44 (0)1132 545 843
Sheila.Greener@doh.gsi.gov.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NIHR Health Technology Assessment Programme - HTA (UK)
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
Basic results (scientific)
Publication list
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
Publication citations
-
HTA monograph
Nixon J, Nelson EA, Cranny G, Iglesias CP, Hawkins K, Cullum NA, Phillips A, Spilsbury K, Torgerson DJ, Mason S, , Pressure relieving support surfaces: a randomised evaluation., Health Technol Assess, 2006, 10, 22, iii-iv, ix-x, 1-163.
-
Nixon J, Cranny G, Iglesias C, Nelson EA, Hawkins K, Phillips A, Torgerson D, Mason S, Cullum N, Randomised, controlled trial of alternating pressure mattresses compared with alternating pressure overlays for the prevention of pressure ulcers: PRESSURE (pressure relieving support surfaces) trial., BMJ, 2006, 332, 7555, 1413, doi: 10.1136/bmj.38849.478299.7C.
-
Iglesias C, Nixon J, Cranny G, Nelson EA, Hawkins K, Phillips A, Torgerson D, Mason S, Cullum N, , Pressure relieving support surfaces (PRESSURE) trial: cost effectiveness analysis., BMJ, 2006, 332, 7555, 1416, doi: 10.1136/bmj.38850.711435.7C.