Chronic leg ulcer Circulatory System Chronic leg ulcer
Conditions
Interventions
Split-thickness skin transplantation
Sponsors
Vivolution A/S (Denmark)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients undergoing surgery for chronic leg ulcer 2. Aged over 18 years 3. Written informed consent, the patient is expected to be able to complete the study 4. Donor site area from 2 x (3 cm x 5 cm) to 2 x (7.6 cm x 15 cm)
Exclusion criteria
Exclusion criteria: 1. Non-Danish speaking 2. Dementia 3. Pregnant or breastfeeding women 4. Patients treated with 10 mg of steroid or more daily 5. Patients that have received thrombocyte-inhibiting medicine less than four days before surgery 6. Patients not suited for general or spinal anaesthesia 7. Patients whose donor site has been used as a donor site before 8. Patients with skin diseases or pathological changes in the skin, including infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Epithelialization on day five and nine post-operatively | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Clinical appearance 2. Histological evaluation 3. Transepidermal Water Loss (TEWL) 4. Erythema 5. Microbiology 6. Incidence of infection 7. Unwanted side effects 8. Temperature difference between treated patients and control group patients | — |
Countries
Denmark
Outcome results
None listed