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Is lowering of shear and friction forces (cost)effective for prevention of pressure ulcers?


- candidate number17028
- NTR NumberNTR4557
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR28-mrt-2014
- Secondary IDsBedcare Plus/MvL 
- Public TitleIs lowering of shear and friction forces (cost)effective for prevention of pressure ulcers?
- Scientific TitleIs lowering of shear and friction forces (cost)effective for prevention of pressure ulcers? A multicenter, prospective, controlled randomized clinical trial in Dutch nursing homes.
- ACRONYMDecuPrev
- hypothesisPrevention of pressure ulcers is a major challenge since there is still an unacceptably high number of clients in nursing homes, care homes and residential care centers where pressure ulcers arise after intake of new residents. The study involves a comparison of a newly developed system which consists of in-use CE-marked equipment parts on a standard visco-elastic foam mattress vs a visco-elastic foam mattress of the same quality for the prevention of pressure ulcers, which can occur while lying on a mattress or bed, or while traveling in/out of bed.
- Healt Condition(s) or Problem(s) studiedPressure ulcers, Prevention, Costs
- Inclusion criteria1. Both genders, age ≥ 60 years, mentally competent or incompetent
2. Life expectation >3 month
3. Chronic patient in nursing home
4. No pressure ulcer in last 3 months
5. Braden score 6-15
6. Patient or his legal representative has read and signed Informed consent form before treatment
- Exclusion criteria1. Patient is participating in another wound study.
2. Patient has any condition(s) like need of hospital care, cancer, sepsis that seriously compromises the patientís ability to complete this study according to the judgment of the MD
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jul-2014
- planned closingdate1-feb-2015
- Target number of participants220
- InterventionsAbout half the population will receive a visco-elastic foam mattress and the other part the same type of mattress with the Bedcare Plus system on top of it.
- Primary outcomeReduction of pressure ulcers on the new system with 30%.
- Secondary outcomeReduction of superficial pressure ulcers related to transfers, reduction of total cost prevention.
- TimepointsPressure ulcer category 1, 2, 3 or 4 according to definitions Richtlijn preventie van decubitus V&VN 2009
Timepoints:13 (1 intake, 1x per week, during 12 weeks)
- Trial web site-
- statusplanned
- CONTACT FOR PUBLIC QUERIES M.W.F. Leen, van
- CONTACT for SCIENTIFIC QUERIES M.W.F. Leen, van
- Sponsor/Initiator SenseTextile BV
- Funding
(Source(s) of Monetary or Material Support)
SenseTextile BV
- PublicationsQ1, 2015
- Brief summary12 nursing homes in a radius of 40 km around Etten-Leur (The Netherlands) are approached to participate. For each center between 8 and max 40 clients are included.
- Main changes (audit trail)
- RECORD28-mrt-2014 - 30-mei-2014


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