Condition category
Skin and Connective Tissue Diseases
Date applied
25/04/2003
Date assigned
25/04/2003
Last edited
26/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.dh.gov.uk/en/index.htm

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

Results - basic reporting

Publication summary

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

  1. 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.

  2. 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.

  3. 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.

Additional files

Editorial Notes