search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Investigation on the effect of shear loading on skin, with application to early detection of skin damage


- candidate number27113
- NTR NumberNTR6401
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR20-apr-2017
- Secondary IDs 
- Public TitleInvestigation on the effect of shear loading on skin, with application to early detection of skin damage
- Scientific TitleInvestigation on the effect of shear loading on cytokine release of human skin
- ACRONYM
- hypothesisWe hypothesize that a certain shear load threshold exists, where an increase in the cytokine IL-1a is observed.
- Healt Condition(s) or Problem(s) studiedPressure ulcers
- Inclusion criteriaAge between 18 and 35
Healthy
Braden score > 20
BMI between 20 and 30 kg/m2
- Exclusion criteriaAny history of skin diseases
Trauma at the volar aspect of the forearms
Known diseases such as: heart diseases, respiratory diseases, diabetes, other diseases to microcirculation, skin diseases, sensory diseases, muscle diseases
Pregnancy
Unable to sit still for 1 hour
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jun-2017
- planned closingdate1-aug-2017
- Target number of participants10
- InterventionsA varying shear load is applied for 1 hour, which is repeated for three sessions. Before and after application of the shear load, a sebutape is applied to absorb the sebum which is present on top of the skin.
- Primary outcomePrimary outcome is the IL-1a concentration in the sebum layer. This concentration is used as biomarker for early detection of pressure ulcers.
- Secondary outcomeNot applicable.
- TimepointsRecruitement starts after acquiring METC approval.
10 Healthy subjects are to be included.
The measurements are plannned to start in June, and are planned to be finished by the end of July.
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES M. Klaassen
- CONTACT for SCIENTIFIC QUERIES M. Klaassen
- Sponsor/Initiator University of Twente
- Funding
(Source(s) of Monetary or Material Support)
STW
- PublicationsNot applicable
- Brief summary10 healthy subjects are included for this research which focusses on reducing pressure ulcer prevalence.
Three different levels of shear load are applied to the volar aspect of the skin after which the concentration of IL-1a is measured using sebutape. It is expected that an increase in IL-1a is observed at a certain shear load threshold, which can be used to tailor surface such that they prevent or reduce pressure ulcers.
- Main changes (audit trail)
- RECORD20-apr-2017 - 21-jun-2017


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl