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
Protocol serial number	HTA 97/06/14
Sponsor	Department of Health (UK)
Funder	NIHR Health Technology Assessment Programme - HTA (UK)

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

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
Email	nac2@york.ac.uk

Study information

Primary study design	Interventional
Study design	Multicentre randomised controlled trial
Secondary study design	Randomised controlled trial
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(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.
Key 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.
Completion date	31/10/2004

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	All
Target sample size at registration	1972
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

United Kingdom
England

Study participating centre

Department of Health Sciences

York
YO10 5DD
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Results article	results	17/06/2006	Yes	No
Other publications	cost-effectiveness analysis	17/06/2006	Yes	No
Other publications	HTA monograph:	01/07/2006	Yes	No