Condition category
Skin and Connective Tissue Diseases
Date applied
19/04/2013
Date assigned
14/05/2013
Last edited
07/05/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The development of pressure ulcers (PUs) in patients staying in hospital is a significant problem in the NHS. Preventive measures include the use of an array of mattress types, cushions and protective clothing. In acute situations the preventative method of choice is the use of an alternating pressure mattress - this mattress type contains many air-filled pockets that inflate and deflate at different times in order to relieve pressure on the body. However, these mattresses are expensive and there is no clear evidence that they are more effective at preventing pressure ulcers than the standard high specification foam mattresses. Also, a previous study indicated that many patients do not like the sensation of lying on an alternating pressure mattress. Therefore, the purpose of this study is to compare the effectiveness of each mattress. The evidence produced in this study will inform more cost effective NHS practice in the future.

Who can participate?
Patients will be eligible at any point during their in-patient stay (and irrespective of Trust provider) if they fulfil the following inclusion criteria:
1. Evidence of acute illness through:
Acute admission to secondary care hospital, community hospital or NHS-funded intermediate care/rehabilitation facility.
Secondary care, community hospital or NHS-funded intermediate care/rehabilitation facility in-patient with onset of acute illness secondary to elective admission.
Recent secondary care hospital discharge to community hospital or NHS-funded intermediate care/rehabilitation facility
2. Aged >= 18 years
3. Have an expected total length of stay of 5 or more days.
4. At high risk of PU development due to one or more of the following:
Bedfast/chair fast AND completely immobile/very limited mobility, Category 1 PU on any pressure area skin site and localised skin pain on a healthy, altered or category 1 pressure area skin site.
5. Consent to participate (written, informed consent/witnessed verbal consent/consultee agreement)
6. Expected to be able to comply with follow-up schedule.
7. The patient is on an electric profiling bedframe.

What does the study involve?
Patients will be randomly allocated to either High Specification Foam (HSF) or Alternating Pressure Mattress (APM - overlay or replacement) products used by the participating centre. All patients will have an electric profiling bed frame as well as the trial mattress. The treatment phase continues until the patient is discharged from hospital, classed no longer at risk of developing a pressure ulcer, or up to a maximum of 60 days. During the treatment phase, patients will receive skin assessments by a tissue viability specialist research nurse twice weekly for the first 30 days and then weekly thereafter until day 60. During each assessment the nurse may also take photographs of any PUs that have developed. In addition, the research nurse will go through a number of questionnaires - this will be done at baseline, visit 2 and visit 6. The questionnaires will be administered again 30 days post trial completion. 10% of patients will receive an independent assessment by a tissue viability specialist not involved in the routine assessments of the trial - this will include photography of all 'at risk' skin sites, including the lower back area and both left and right buttocks. The purpose of this additional assessment is to ensure that identification of PUs is reported correctly.

What are the possible benefits and risks of participating?
There will be no direct benefits; however, the study will seek to generate robust evidence for the effectiveness of APM or HSF in preventing pressure ulcers, which is a key priority in the NHS.

Where is the study run from?
This study is a multicentre trial and will be coordinated by the Institute of Clinical Trials Research at the University of Leeds (UK).

When is the study starting and how long is it expected to run for?
The study will begin recruitment in September 2013 and will run until June 2016. However, the study has been designed with the possibility of early stopping depending on the results that are observed.

Who is funding the study?
NIHR Health Technology Assessment Programme - HTA (UK).

Who is the main contact?
Professor Jane Nixon PhD, RN
j.e.nixon@leeds.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Jane Nixon

ORCID ID

Contact details

Institute of Clinical Trials Research
Fairbairn House
71-75 Clarendon Rd
University of Leeds
Leeds
LS2 9JT
United Kingdom
+44 (0)113 343 1477
j.e.nixon@leeds.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 11/36/33, version 4.0

Study information

Scientific title

Pressure RElieving Support SUrfaces: a Randomised Evaluation 2

Acronym

PRESSURE 2

Study hypothesis

The aim of this study is to determine the clinical and cost effectiveness of high specification foam (HSF) and alternating pressure mattresses (APM) when both are used in conjunction with an electric profiling bed frame in high-risk acute hospital patients.

More details can be found at http://www.nets.nihr.ac.uk/projects/hta/113633
Protocol can be found at http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0003/96465/PRO-11-36-33.pdf

Ethics approval

Leeds West NRES committee, 17/04/2013, ref: 13/YH/0066

Study design

Multicentre open randomised double triangular sequential parallel group trial with two planned interim analyses

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Pressure ulcers (PUs)

Intervention

Patients eligible for the study and providing written informed consent (or consultee/nominated consultee agreement) will be randomised to receive either an alternating pressure mattress or a high specification foam mattress. Participants will be defined as 'on treatment' until day 60 post randomisation, or discharge or deemed no longer at risk, whichever is soonest. Participants will be followed up 30 days post trial completion.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Current primary outcome measures as of 04/07/2014:
To compare time to developing a new Category 2 or above PU, in patients using HSF to those using APM from randomisation to 30 days post treatment phase.

Previous primary outcome measures:
Time to developing a new Category 2 or above PU from randomisation to 30 days post trial completion or withdrawal/death (maximum of 90 days).

Secondary outcome measures

Current secondary outcome measures as of 04/07/2014:
1. To compare time to developing a new Category 3 or above PU, between patients using HSF and those using APM
2. To compare time to developing a new Category 1 or above PU, between patients using HSF and those using APM
3. To compare time to healing of pre-existing Category 2 pressure ulcers between patients using HSF and those using foam
4. To determine the impact of HSF and APM on health-related quality of life using SF-12 and PU-QoL instruments
5. To determine the incremental cost-effectiveness of APM compared to HSF from the perspective of the health and social care sectors using EQ-5D and health and social care resource utilization questionnaire
6. To compare incidence of mattress change between patients using HSF and those using APM
7. To compare safety between patients using HSF and those using APM

Previous secondary outcome measures:
1. Time to developing a PU of Category 3 or above from randomisation to 30 days post trial completion or withdrawal/death
2. Time to developing a PU of Category 1 or above from randomisation to 30 days post trial completion or withdrawal/death
3. Time to healing of pre-existing Category 2 pressure ulcers from randomisation to 30 days post trial completion or withdrawal/death
4. Health-related quality of life using SF-12 and PU-QoL instruments (assessed weekly until day 30 and then fortnightly until day 60, and then at 30 days post trial completion)
5. Incremental cost-effectiveness of APM compared to HSF from the perspective of the health and social care sectors using EQ-5D and health and social care resource utilization questionnaire

Overall trial start date

01/09/2013

Overall trial end date

01/04/2018

Reason abandoned

Eligibility

Participant inclusion criteria

Current inclusion criteria as of 04/07/2014:
1. Evidence of acute illness through:
1.1. Acute admission to secondary care hospital, community hospital or NHS-funded intermediate care/rehabilitation facility
1.2. Secondary care, community hospital or NHS-funded intermediate care/rehabilitation facility in-patient with onset of acute illness secondary to elective admission
1.3. Recent secondary care hospital discharge to community hospital or NHS-funded intermediate care/ rehabilitation facility
2. Aged 18 years or over, either sex
3. Have an expected total length of stay of 5 or more days
4. At high risk of PU development due to one or more of the following:
4.1. Bedfast/chairfast AND completely immobile/very limited mobility (Braden Activity score 1 or 2 and Mobility score 1 or 2)
4.2. Category 1 PU on any pressure area skin site
4.3. Localised skin pain on any pressure area skin site
5. Consent to participate (written, informed consent/witnessed verbal consent/consultee agreement)
6. Expected to be able to comply with follow-up schedule

Previous inclusion criteria:
1. Acute hospital admission under the care of a vascular, orthopaedic, surgery, medical or care of the elderly hospital consultant; or community hospital admission (i.e., rehabilitation ward/unit) receiving consultant-led care
2. Aged 18 years or over, either sex
3. Have an expected total length of stay of 5 or more days
4. At high risk of PU development due to one or more of the following:
4.1. Bedfast/chairfast AND completely immobile/very limited mobility (Braden Activity score 1 or 2 and Mobility score 1 or 2)
4.2. Category 1 PU on any pressure area skin site
4.3. Localised skin pain on any pressure area skin site
5. Consent to participate (written, informed consent/witnessed verbal consent/consultee agreement)
6. Expected to be able to comply with follow-up schedule.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

2954 patients, but with the possibility of early stopping with two interim analyses

Participant exclusion criteria

Current exclusion criteria as of 04/07/2014:
1. Have previously participated in the Pressure 2 trial
2. Have a current or previous Category 3 or greater PU
3. Have planned admission to ICU (where standard care is alternating pressure mattress provision)
4. Unable to receive the intervention (for example, sleep at night in a chair or unable to be transferred to randomised mattress)
5. Patient weight is lower or higher than weight limits for HSF and alternating pressure mattresses (<45 kg/>180 kg)
6. It is ethically inappropriate to approach the patient

Previous exclusion criteria:
1. Acute hospital admission under the care of the General Practitioner
2. Have previously participated in the trial
3. Have a current or previous Category 3 or greater PU
4. Have planned admission to ICU (where standard care is alternating pressure mattress provision)
5. Unable to receive the intervention (for example, sleep at night in a chair or unable to be transferred to randomised mattress)
6. Patient weight is lower or higher than weight limits for HSF and alternating pressure mattresses (<45 kg/>180 kg)

Recruitment start date

01/09/2013

Recruitment end date

01/06/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Institute of Clinical Trials Research
Leeds
LS2 9JT
United Kingdom

Sponsor information

Organisation

University of Leeds (UK)

Sponsor details

Faculty Research Ethics and Governance Administrator
Faculty Research Office
Room 10.110
Level 10
Worsley Building
Clarendon Way
Leeds
LS2 9LN
United Kingdom
+44 (0)113 343 2274
governance-ethics@leeds.ac.uk

Sponsor type

University/education

Website

http://www.leeds.ac.uk/

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (UK), ref: 11/36/33

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

01/10/2017

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes