Randomised controlled trial comparing alternating pressure overlays with alternating pressure mattresses for pressure sore prevention and treatment
| ISRCTN | ISRCTN78646179 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN78646179 |
| Secondary identifying numbers | HTA 97/06/14 |
- Submission date
- 25/04/2003
- Registration date
- 25/04/2003
- Last edited
- 26/08/2009
- 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
Not provided at time of registration
Contact information
Dr Nicky Cullum
Scientific
Scientific
Department of Health Sciences
University of York
Alcuin College
Area 2
Seebohm Rowntree Building
Heslington
York
YO10 5DD
United Kingdom
| Phone | +44 (0)1904 321343 |
|---|---|
| nac2@york.ac.uk |
Study information
| Study design | Multicentre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Prevention |
| Scientific title | |
| Study acronym | PRESSURE |
| Study objectives | 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(s) | 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. |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/05/2000 |
| Completion date | 31/10/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 1,972 |
| Key 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. |
| Key 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. |
| Date of first enrolment | 01/05/2000 |
| Date of final enrolment | 31/10/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Health Sciences
York
YO10 5DD
United Kingdom
YO10 5DD
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
| Phone | +44 (0)1132 545 843 |
|---|---|
| Sheila.Greener@doh.gsi.gov.uk | |
| Website | http://www.dh.gov.uk/en/index.htm |
"ROR" |
https://ror.org/03sbpja79 |
Funders
Funder type
Government
NIHR Health Technology Assessment Programme - HTA (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other publications | cost-effectiveness analysis | 17/06/2006 | Yes | No | |
| Results article | results | 17/06/2006 | Yes | No | |
| Other publications | HTA monograph: | 01/07/2006 | Yes | No |
