Healing of split-skin graft donor site.
Conditions
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-t
Sponsors
Department of Plastic and Reconstructive Surgery
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical improvement of the donor site wound, measured as reduction in wound size in time. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Contacts
Public ContactJ.W. Neck, van
Dept of Plastic Surgery, Ee15.91 's Gravendijkwal 230
Outcome results
None listed