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van CCT (UK)


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van CCT (UK)


Effect of pressure and shear on skin vitality


- candidate number22352
- NTR NumberNTR5256
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR17-jun-2015
- Secondary IDsNL53767.044.15 CCMO, www.toetsingonline.nl
- Public TitleEffect of pressure and shear on skin vitality
- Scientific TitleInvestigation into the effect of pressure and shear on tissue viability of human skin
- ACRONYM
- hypothesisThis study will investigate the effect of shear and pressure on tissue viability of human skin. Skin vitality is determined by tissue oxygenation and blood flow, measured with the 'Oxygen to See'. The focus will be on individual response patterns and possibly identification of groups of response patterns. The aim of this study is to gather new knowledge on the effect of shear and thereby help in quantifying the risk for development of pressure ulcers.
- Healt Condition(s) or Problem(s) studiedPressure ulcers, Skin blood flow
- Inclusion criteriaHealthy participants
- Age between 18 and 35 years OR 60 years or older
- Considered to be healthy
- Caucasian/ white skin color

Spinal Cord Injured patients
- Minimal 1 year after lesion
- Complete spinal cord injury
- Wheelchair bound in daily life
- Caucasian/ white skin color
- Exclusion criteriaHealthy participants
- Skin colour deviations at site of measurement
- Surgery at the area of measurement
- Pregnancy
- Unable of lying still for 2 hours
- History of pressure ulcers or other circulation diseases (e.g. diabetes)

Spinal Cord Injured patients
- Skin colour deviations at site of measurement
- Surgery at the area of measurement
- Pregnancy
- Unable of lying still for 1 hour
- A pressure ulcer category 2 or higher in the past year
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- Type[default]
- Studytypeintervention
- planned startdate 1-jul-2015
- planned closingdate1-aug-2016
- Target number of participants30
- InterventionsApplication of eight different randomised (block randomisation) pressure and shear combinations on the sacrum. Each condition start with a one minute baseline (no load), followed by application of the load during 5 minutes and after load removal the reaction will be measured for 7.5 minutes.
- Primary outcomeOxygensaturation and blood flow, during and after load application. The change in these parameters for different combinations of pressure and shear.
- Secondary outcomeTissue thickness (muscle, subcutaneous fat and skin), group effects.
- TimepointsIntervention is scheudled in one or two session (maximal 7 days apart). During these sessions the primary and secondairy parameters will be measured.
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESMSc I. Hoogendoorn
- CONTACT for SCIENTIFIC QUERIESMSc I. Hoogendoorn
- Sponsor/Initiator Roessingh Research and Development
- Funding
(Source(s) of Monetary or Material Support)
STW/NWO
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD17-jun-2015 - 16-aug-2015


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