Contact information
Type
Scientific
Primary contact
Mr Patriek Mistiaen
ORCID ID
Contact details
Netherlands Institute for Health Services Research (NIVEL)
P.O. Box 1568
Utrecht
3500 BN
Netherlands
+31 (0)30 272 9779
p.mistiaen@nivel.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study 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.
Ethics approval
Approval received from the local ethics committee (METC Universitair Medisch Centrum Utrecht) on the 2nd January 2007 (ref: NL14075.041.06).
Study design
Randomised, active-controlled, parallel group multicentre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Pressure ulcers
Intervention
Australian Medical Sheepskin plus usual care during first 30 days after admission to a nursing home versus usual care only.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. Incidence and prevalence of pressure ulcers on the sacrum in the first month after admission
2. Costs
Secondary outcome measures
1. Sacrum pressure ulcer free days
2. Adverse events
3. Comfort/ease of use
Overall trial start date
01/05/2007
Overall trial end date
01/11/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. Adults
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 one ulcer)
5. Having an expected stay of more than one week
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
750
Participant exclusion criteria
1. Admitted for a primarily pyscho-geriatric reason
2. Having sacral pressure ulcers at admission
Recruitment start date
01/05/2007
Recruitment end date
01/11/2008
Locations
Countries of recruitment
Netherlands
Trial participating centre
Netherlands Institute for Health Services Research (NIVEL)
Utrecht
3500 BN
Netherlands
Sponsor information
Organisation
Netherlands Institute for Health Services Research (NIVEL) (The Netherlands)
Sponsor details
P.O. Box 1568
Utrecht
3500 BN
Netherlands
+31 (0)30 272 9700
receptie@nivel.nl
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
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
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2008 protocol in http://www.ncbi.nlm.nih.gov/pubmed/18179714
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/20946141
Publication citations
-
Protocol
Mistiaen P, Achterberg W, Ament A, Halfens R, Huizinga J, Montgomery K, Post H, Francke AL, Cost-effectiveness of the Australian Medical Sheepskin for the prevention of pressure ulcers in somatic nursing home patients: study protocol for a prospective multi-centre randomised controlled trial (ISRCTN17553857)., BMC Health Serv Res, 2008, 8, 4, doi: 10.1186/1472-6963-8-4.
-
Results
Mistiaen P, Achterberg W, Ament A, Halfens R, Huizinga J, Montgomery K, Post H, Spreeuwenberg P, Francke AL, The effectiveness of the Australian Medical Sheepskin for the prevention of pressure ulcers in somatic nursing home patients: a prospective multicenter randomized-controlled trial (ISRCTN17553857)., Wound Repair Regen, 18, 6, 572-579, doi: 10.1111/j.1524-475X.2010.00629.x.