Cost-effectiveness of the Australian medical sheepskin for the prevention of pressure ulcers in somatic nursing home clients

ISRCTN ISRCTN17553857
DOI https://doi.org/10.1186/ISRCTN17553857
Secondary identifying numbers N/A
Submission date
08/02/2007
Registration date
08/02/2007
Last edited
04/07/2011
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Skin and Connective Tissue Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Patriek Mistiaen
Scientific

Netherlands Institute for Health Services Research (NIVEL)
P.O. Box 1568
Utrecht
3500 BN
Netherlands

Phone +31 (0)30 272 9779
Email p.mistiaen@nivel.nl

Study information

Study designRandomised, active-controlled, parallel group multicentre trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study objectivesResearch 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(s)Approval received from the local ethics committee (METC Universitair Medisch Centrum Utrecht) on the 2nd January 2007 (ref: NL14075.041.06).
Health condition(s) or problem(s) studiedPressure ulcers
InterventionAustralian Medical Sheepskin plus usual care during first 30 days after admission to a nursing home versus usual care only.
Intervention typeOther
Primary outcome measure1. Incidence and prevalence of pressure ulcers on the sacrum in the first month after admission
2. Costs
Secondary outcome measures1. Sacrum pressure ulcer free days
2. Adverse events
3. Comfort/ease of use
Overall study start date01/05/2007
Completion date01/11/2008

Eligibility

Participant type(s)Patient
Age groupAdult
SexNot Specified
Target number of participants750
Key inclusion criteria1. 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
Key exclusion criteria1. Admitted for a primarily pyscho-geriatric reason
2. Having sacral pressure ulcers at admission
Date of first enrolment01/05/2007
Date of final enrolment01/11/2008

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Netherlands Institute for Health Services Research (NIVEL)
Utrecht
3500 BN
Netherlands

Sponsor information

Netherlands Institute for Health Services Research (NIVEL) (The Netherlands)
Research organisation

P.O. Box 1568
Utrecht
3500 BN
Netherlands

Phone +31 (0)30 272 9700
Email receptie@nivel.nl
Website http://www.nivel.nl/
ROR logo "ROR" https://ror.org/015xq7480

Funders

Funder type

Research organisation

The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 07/01/2008 Yes No
Results article results 01/11/2011 Yes No