|- candidate number||2423|
|- NTR Number||NTR878|
|- Date ISRCTN created||8-feb-2007|
|- date ISRCTN requested||7-feb-2007|
|- Date Registered NTR||23-jan-2007|
|- Secondary IDs||N/A |
|- Public Title||Cost-effectiveness of the Australian Medical Sheepskin for the prevention of pressure ulcers in somaticnursing home clients|
|- Scientific Title||Cost-effectiveness of the Australian Medical Sheepskin for the prevention of pressure ulcers in somatic nursing home clients|
|- ACRONYM||Cost-effectiveness of the Australian Medical Sheepskin |
|- hypothesis||Research questions are:
1. What are the effects of appliance of Australian Medical Sheepskins on the incidence and prevalence rates of sacral pressure ulcers in somatic nursing home clients in the first month after admission compared to usual care?
2. What are the costs of appliance of Australian Medical Sheepskins compared to usual care?
3. What are the costs of the treatment for eventually developed pressure ulcers in the two study groups?
4. What adverse effects do Australian Medical Sheepskins have?
5. How do patients and nursing and caring personnel rate the (dis)comfort of Australian Medical Sheepskins and the ease of use of Australian Medical Sheepskins?
For this study we will consider the Australian Medical Sheepskin as effective if the incidence rate in the first month after
admission is at least (absolute) 10% less in the experimental group than in the control group and the prevalence numbers at two moments during the research period are (absolute) 10% lower in the
experimental group than in the control group.|
|- Healt Condition(s) or Problem(s) studied||Pressure ulcers|
|- Inclusion criteria||1. Adult
2. Admitted for a somatic reason;
3. Free of sacral pressure ulcer;
4. Not having a darkly pigmented skin (because of difficulty to diagnose stage 1 ulcer);
5. Having an expected stay of more than one week.|
|- Exclusion criteria||1. Admitted for a primarily pyscho-geriatric reason;
2. Having sacral pressure ulcers at admission.|
|- mec approval received||yes|
|- multicenter trial||yes|
|- planned startdate ||1-mei-2007|
|- planned closingdate||1-nov-2008|
|- Target number of participants||750|
|- Interventions||Australian Medical Sheepskin plus usual care during first 30 days after admission to a nursing home VERSUS usual care only|
|- Primary outcome||1. Incidence and prevalence of pressure ulcers on the sacrum in the first month after admission;
2. Costs. |
|- Secondary outcome||1. Sacrum pressure ulcer free days;
2. Adverse events;
3. Comfort / ease of use. |
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES||nurse researcher Patriek Mistiaen|
|- CONTACT for SCIENTIFIC QUERIES||nurse researcher Patriek Mistiaen|
|- Sponsor/Initiator ||Nederlands instituut voor onderzoek van de gezondheidszorg (NIVEL)|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||Cost-effectiveness of the Australian Medical Sheepskin for the prevention of pressure ulcers in somatic nursing home clients
Background of the study: Pressure ulcers are a very common problem in nursing home patients and have a high burden. Earlier research demonstrated a preventive effect of the Australian Medical sheepskin in hospital patients. Probably there will be the same preventive effect of the sheepskin in nursing home patients.
Objective of the study: To assess the effects and costs of the use of the Australian Medical Sheepskin and usual care with regard to the prevention of sacral pressure ulcers in somatic nursing home clients, versus usual care only.
Intervention (if applicable): The experimental condition is use of the Australian Medical Sheepskin as
an overlay on the mattress in combination with usual care. The control condition is the usual care. In both conditions usual nursing co-interventions (e.g. mobilisation and repositioning schemes) may be applied. It is also allowed to apply other pressure-relieving equipment (e.g. foam mattresses), as normally used in that nursing home, as soon as pressure ulcers occur or are expected. For both conditions there will be a concise registration of all care and devices applied.
As far as we know there are only minimal burden or risks with the application of the Australian Medical Sheepskin. The research burden consist of daily skin inspection of 2 minutes during thirty days and responding to a short questionnaire about comfort and ease of use of the sheepskins.
|- Main changes (audit trail)|
|- RECORD||23-jan-2007 - 9-feb-2007|