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Rembrandt trial.


- candidate number5912
- NTR NumberNTR1849
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR9-jun-2009
- Secondary IDs AMR project number
- Public TitleRembrandt trial.
- Scientific TitleRecognising Effective Materials By Randomising & Assessing New Donorsite Treatments.
- ACRONYMRembrandt
- hypothesisThe healing of donor site wounds after split-skin grafting can be promoted by the use of one of five specific wound dressing materials as compared in this trial.
- Healt Condition(s) or Problem(s) studiedWound healing, Skin graft
- Inclusion criteria1. Adults;
2. Condition requiring split-skin grafting;
3. Donor site of at least 10 cm2;
4. Written informed consent.
- Exclusion criteria1. Patients physically or mentally not able to consent;
2. Patients with impaired wound healing (e.g. chemotherapy).
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-okt-2009
- planned closingdate1-okt-2011
- Target number of participants250
- InterventionsOne of the following wound dressings will be randomly applied:
1. Paraffin gauze;
2. Film;
3. Hydrocolloid;
4. Alginate;
5. Silicone.
- Primary outcomeTime to complete wound healing.
- Secondary outcome1. Pain;
2. Infection rate;
3. Itching;
4. Patient comfort;
5. Costs.
- TimepointsAt various time points during the healing process.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES H. Vermeulen
- CONTACT for SCIENTIFIC QUERIESDr. D.T. Ubbink
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Dutch Burn Wound Society
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD9-jun-2009 - 30-sep-2009


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