Pressure ulcers (PUs) Skin and Connective Tissue Diseases Decubitus ulcer and pressure area
Conditions
Interventions
Added 10/02/2017: Participants are randomised using minimisation incorporating a random element via a central 24-hour automated telephone randomisation system.
Patients eligible for t
Sponsors
University of Leeds (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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 (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 (180 kg)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United Kingdom
Outcome results
None listed