- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02020655
Measurement of Cytokines (IL-1α) After Shear- Force Application at the Skin
Background: A pressure ulcer is localized tissue injury to the superficial layer of the skin and/ or the underlying tissue. Pressure ulcers are most likely to develop in skin areas exposed to pressure, shear and friction. Shear- force is an important contributing factor and wound dressing are possibly capable to reduce shear force at the skin. At this moment there's no good marker to detect the effect of shear- force at the skin. A potential marker could be cytokines (IL-1α) which are released after mechanical loading of the skin. A previous study have shown a significant increased level of IL-1α after the application of pressure. We want to investigate if these cytokines are significant increased after the application of shear- force at the skin.
Objective: The objective of this study is to gather knowledge about cytokine concentrations (IL-1 α) in the skin of healthy volunteers after the application of shear- force. We want to use this knowledge in the future to investigate if different prophylactic wound dressings are capable to reduce shear force at the skin. This could be interesting in the prevention of pressure ulcers.
Study design: With the use of a special developed shear- force model are we going to administer 20 Newton (2 kg) shear at the palmar side of the under arm in 10 healthy volunteers for 30 minutes. As a control we ware going to put the shear- force model at the other arm without the application of shear- force. Before the use of the shear- force model we will perform cytokine measurements with the use of Sebutape. Sebutape is capable to absorb cytokines from the skin. After the use of the shear force- model we will perform cytokine measurements again. Then we will extract the cytokines from the Sebutape with the use of ELISA.
Study population: 10 Healthy volunteers Age 18- 30 years
Primary outcome: IL-1 α concentration (pg/ml)
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
Limburg
-
Maastricht, Limburg, Nederland, 6229 HX
- Maastricht University Medical Centre
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Age 18- 30 years
- BMI 20 -30
- Braden score > 20
Exclusion Criteria:
- Trauma arms
- Skin diseases (eczema, psoriasis)
- Inability to give informed consent
- Muscle disorders
- malignancy
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
10 healthy volunteers
Shear- force model
|
Shear- force model
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
IL-1 α concentration (pg/ml)
Tidsramme: up to 24 hours
|
With the use of a special developed shear- force model are we going to administer 20 Newton (2 kg) shear at the palmar side of the under arm in 10 healthy volunteers for 30 minutes.
As a control we ware going to put the shear- force model at the other arm without the application of shear- force.
Before the use of the shear- force model we will perform cytokine measurements with the use of Sebutape.
Sebutape is capable to absorb cytokines from the skin.
After the use of the shear force- model we will perform cytokine measurements again.
|
up to 24 hours
|
Samarbeidspartnere og etterforskere
Etterforskere
- Studiestol: Nicole Bouvy, MD, PhD, Department of surgery, Maastricht University Medical Centre
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- NL46877.068.13
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