OTR4120: topical application at split-skin graft donor sites. A clinical evaluation of cicatrisation.

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.

OTR4120 will improve healing of split-skin graft donor sites.

Day 7, Day 12, Week 12

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.