Woman and Man
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Extract
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 [email protected]
Inclusion criteria
- Pressure ulcers (PUs)