|- candidate number||5079|
|- NTR Number||NTR1619|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||8-jan-2009|
|- Secondary IDs||2008-374 MEC Erasmus MC|
|- Public Title||OTR4120: topical application at split-skin graft donor sites. A clinical evaluation of cicatrisation.|
|- Scientific Title||OTR4120: topical application at split-skin graft donor sites. A clinical evaluation of cicatrisation.|
|- ACRONYM||OTR4120 application to skin graft donor sites.|
|- hypothesis||OTR4120 will improve healing of split-skin graft donor sites.|
|- Healt Condition(s) or Problem(s) studied||Skin complaints|
|- Inclusion criteria||1. Signed informed consent;|
2. Aged over 18 yrs;
3. Patients in need of an autologous skin graft;
4. Adequate nutritional state;
5. Adequate immuno-competence;
6. Regulated diabetes mellitus;
7. Women in reproductive age take contraceptive medication.
|- Exclusion criteria||1. Minor patients;|
2. Pregnant or breastfeeding women;
3. Patient involved in another clinical trial, currently or less that 1 month before participation in this study;
4. Size of split-skin graft donor site is less than 7x18 cm;
5. Patients unable to sign the informed consent;
6. Patients unable to indicate their level of pain and itch;
7. Uninsured patients.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-feb-2009|
|- planned closingdate||31-dec-2009|
|- Target number of participants||19|
|- Interventions||Intra-patient trial: split-skin donor site is dived into 3 parts. Proximal and distal receive placebo or OTR4120-treatment. Middle part is non-treated to prevent carry-over effects.
For the OTR4120-treated part of the split-skin graft donor site, the medical device Cacipliq20 consists of a sterile solution of OTR4120 (100 microgram/ml in physiological salt).
For the placebo-treated part of the split-skin graft donor site, the medical device Cacipliq20 consists of a sterile solution of physiological salt.
|- Primary outcome||Clinical improvement of the donor site wound, measured as reduction in wound size in time. |
|- Secondary outcome||1. Complete healing of the wound, measured as the time needed for complete healing.|
2. Improvement of the quality of the (former) wound area to be measured as the amount of vascularisation, scar formation, skin pigmentation and elasticity.
3. Pain reduction.
4. Itch reduction.
|- Timepoints||Day 7, Day 12, Week 12|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Dr. J.W. Neck, van |
|- CONTACT for SCIENTIFIC QUERIES||Dr. J.W. Neck, van |
|- Sponsor/Initiator ||Erasmus Medical Center - Department of Plastic and Reconstructive Surgery|
(Source(s) of Monetary or Material Support)
|Dutch Burns Foundation (Nederlandse Brandwonden Stichting)|
|- Brief summary||This study aims to investigate, in a double blinded, randomized controlled trial, the effectiveness of treatment of split-skin graft donor sites with a new product, in which a regenerating agent (RGTA), made of sugar, reactivates at very low doses our natural regeneration potential. In total, 19 patients with split-skin graft donor sites will be included. The product will be applied for only 5 minutes and removed. This is enough for this sugar to bind and to protect the matrix proteins of the wound bed and to allow the tissue to repair. This treatment will be followed by standard care. Patient follow-up is 12 weeksThe study is for a duration of 12 weeks for each patient. From preliminary studies improved healing characteristics and a reduction in time to complete healing and pain are expected without any side effects. |
|- Main changes (audit trail)|
|- RECORD||8-jan-2009 - 9-sep-2009|