Condition category
Skin and Connective Tissue Diseases
Date applied
08/02/2007
Date assigned
08/02/2007
Last edited
04/07/2011
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.nivel.nl/

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

  1. 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.

  2. 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.

Additional files

Editorial Notes