Pressure RElieving Support SUrfaces: a Randomised Evaluation 2
- Conditions
- Pressure ulcers (PUs)Skin and Connective Tissue DiseasesDecubitus ulcer and pressure area
- Registration Number
- ISRCTN01151335
- Lead Sponsor
- niversity of Leeds (UK)
- Brief Summary
2016 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/27993145 2017 photographic validation sub-study protocol in: https://www.ncbi.nlm.nih.gov/pubmed/28320482 2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31559948 (added 01/10/2019) 2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31709401 (added 13/11/2019) 2021 results in https://pubmed.ncbi.nlm.nih.gov/33910607/ (added 30/04/2021)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 2029
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.
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Current primary outcome measures as of 04/07/2014:<br> 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.<br><br> Previous primary outcome measures:<br> 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).<br>
- Secondary Outcome Measures
Name Time Method