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
Scientific
Netherlands Institute for Health Services Research (NIVEL)
P.O. Box 1568
Utrecht
3500 BN
Netherlands
| Phone | +31 (0)30 272 9779 |
|---|---|
| p.mistiaen@nivel.nl |
Study information
| Study design | Randomised, active-controlled, parallel group multicentre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | 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(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) studied | 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 |
| Primary outcome measure | 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 study start date | 01/05/2007 |
| Completion date | 01/11/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target number of participants | 750 |
| Key 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 |
| Key exclusion criteria | 1. Admitted for a primarily pyscho-geriatric reason 2. Having sacral pressure ulcers at admission |
| Date of first enrolment | 01/05/2007 |
| Date of final enrolment | 01/11/2008 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Netherlands Institute for Health Services Research (NIVEL)
Utrecht
3500 BN
Netherlands
3500 BN
Netherlands
Sponsor information
Netherlands Institute for Health Services Research (NIVEL) (The Netherlands)
Research organisation
Research organisation
P.O. Box 1568
Utrecht
3500 BN
Netherlands
| Phone | +31 (0)30 272 9700 |
|---|---|
| receptie@nivel.nl | |
| Website | http://www.nivel.nl/ |
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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 |
