| Source of record | UK Trials |
| ISRCTN | ISRCTN78646179 |
| Date ISRCTN assigned | 25/04/2003 |
| Local reference number(s) | HTA 97/06/14 |
| Public title | Randomised controlled trial comparing alternating pressure overlays with alternating pressure mattresses for pressure sore prevention and treatment |
| Scientific title |
|
| Acronym | PRESSURE |
| Disease/condition/study domain | Pressure sores |
| 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). |
| Design/methodology | Multicentre randomised controlled trial |
| Research ethics review | 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.
|
| Countries of trial | United Kingdom |
| 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. |
| Patient information material | Not provided at time of registration |
| Anticipated start date | 01/05/2000 |
| Anticipated end date | 31/10/2004 |
| Status of trial | Completed |
| Target number of participants | 1972 |
| 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. |
| Publications | Cost-effectiveness analysis in: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16740528
Results in: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16740530
HTA monograph: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16750060 |
| Sources of funding | NIHR Health Technology Assessment Programme - HTA (UK) |
| Sponsor name | Department of Health (UK) |
| Sponsor details | Quarry House
Quarry Hill
Leeds
United Kingdom
LS2 7UE |
| Sponsor email | Sheila.Greener@doh.gsi.gov.uk |
| Sponsor website | http://www.dh.gov.uk/en/index.htm |
| Contact name | Dr Nicky Cullum |
| Contact details | Department of Health Sciences
University of York
Alcuin College
Area 2
Seebohm Rowntree Building
Heslington
York
United Kingdom
YO10 5DD |
| Contact telephone | +44 (0)1904 321343 |
| Contact fax | +44 (0)1904 321383 |
| Contact email | nac2@york.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN78646179 |
| Date last extracted from ISRCTN register | 17/04/2008 |
