wound healing
Conditions
Interventions
Dose escalation group 1:10µg/cm2 exosome will be given after split-skin acquisition. If there is no adverse reaction, it is considered as a safe dose. If one patient has an adverse reaction, two more
Dose escalation group 2:20 µg/cm2 exosome will be given after split-skin acquisition. If there is no adverse reaction, it is considered as a safe dose. If one patient has an adverse reaction, two more
Dose escalation group 3:33 µg/cm2 exosome will be given after split-skin acquisition. If there is no adverse reaction, it is considered as a safe dose. If one patient has an adverse reaction, two more
Dose escalation group 4:50 µg/cm2 exosome will be given after split-skin acquisition. If there is no adverse reaction, it is considered as a safe dose. If one patient has an adverse reaction, two more
Sponsors
Burns and Cutaneous Surgery, First affiliated hospital of air force medical university
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: (1) Patients aged 18 to 60, regardless of gender. (2) Patients have to process skin transplantation and split-skin is needed. The surgical plan shall be evaluated by two attending surgeons. (3) The donor site is normal skin in the anterolateral region of back or thigh. (4) Written informed consent will be given to patients before they are included in this study. Patients should coordinate the treatment and be able to visit hospital as required.
Exclusion criteria
Exclusion criteria: 1. The area involved in surgery is greater than 10%TBSA; 2. Patients are diagnosed as serious dysfunction of heart, brain, liver, kidney or other organs, or related skin diseases that may delay wound healing; 3. Patients undergoing general anesthesia within 1 week after this surgery; 4. The donor site is located at a high risk of infection, such as near the currently infected wound (much purulent discharge). 5. Patients with immune dysfunction, HIV infection, or who have been treated with radiation, hormones (systemic drugs), chemotherapy, growth factors, and immunosuppressive drugs within 1 month; 6. Patients who are diagnosed with malignant tumors, autoimmune disease, epidermolysis bullosa; 7. Unstable blood glucose control, such as fasting blood glucose =8.0mmol/L or postprandial blood glucose =12.0mmol/L; 8. WBC > 10×10e9/L 9. Those who have mental disorders and have no self-knowledge and cannot express themselves accurately; 10. Patients who are considered by the investigator to have a significant medical condition that may affect the study. 11. Maternal or other investigator assessments are not suitable for participating investigators;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| wound healing time; | — |
Secondary
| Measure | Time frame |
|---|---|
| inflammation of wound;Wound pain assessment;Vancouver Scar Scale; | — |
Countries
China
Contacts
Public ContactXuekang Yang
First affiliated hospital of air force medical university
Outcome results
None listed