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van CCT (UK)


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van CCT (UK)


The effect of hydrocolloid dressing (XtraSorb HCS) compared to silicon foam dressing (Mepilex) or alginate (Kaltostat) and semipermeable film (Tegaderm) on the donorsite after split thickness skin graft: a randomized controlled trial.


- candidate number22867
- NTR NumberNTR5441
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR17-sep-2015
- Secondary IDs 
- Public TitleThe effect of hydrocolloid dressing (XtraSorb HCS) compared to silicon foam dressing (Mepilex) or alginate (Kaltostat) and semipermeable film (Tegaderm) on the donorsite after split thickness skin graft: a randomized controlled trial.
- Scientific TitleThe effect of hydrocolloid dressing (XtraSorb HCS) compared to silicon foam dressing (Mepilex) or alginate (Kaltostat) and semipermeable film (Tegaderm) on the donorsite after split thickness skin graft: a randomized controlled trial.
- ACRONYMSHAFE
- hypothesisH0: all three regimens are comparable in terms of patient comfort and re-epithelialization.
H1: hydrocolloid is superior to silicon foam or alginate and semipermeable film in terms of patient comfort and re-epithelialization.
- Healt Condition(s) or Problem(s) studiedSkin graft, Pain
- Inclusion criteriaAll patients older than 18 years after split thickness skin graft and signed informed consent.
- Exclusion criteria< 18 years.
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-dec-2015
- planned closingdate30-nov-2016
- Target number of participants75
- InterventionsGroup 1: silicon foam dressing (Mepilex)
Group 2: hydrocolloid dressing (XtraSorb HCS)
Group 3: or alginate (Kaltostat) and semipermeable film (Tegaderm)
- Primary outcomeRe-epithelialization
- Secondary outcomePatient comfort
Infection
Number of dressing changes
- TimepointsDay 1, 5, 9, 14, 21, 90 postoperative.
- Trial web siteData management in Castor.
- statusplanned
- CONTACT FOR PUBLIC QUERIES Stephanie de Jong
- CONTACT for SCIENTIFIC QUERIES Stephanie de Jong
- Sponsor/Initiator Antoni van Leeuwenhoek
- Funding
(Source(s) of Monetary or Material Support)
Antoni van Leeuwenhoek
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD17-sep-2015 - 22-nov-2015


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