Wound of medium thickness donor site in burn patients
Conditions
Interventions
High dose stem cell gel group:High dose stem cell gel (60000 cells/cm2) was applied to the wound as an inner dressing.
Low dose stem cell gel group:Low dose stem cell gel (30000 cells/cm2) was applied to the wound as an inner dressing.
Individual gel group:Gel without stem cell was applied to the wound as an inner dressing.
Sponsors
Zhengzhou First People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Patients who voluntarily participate and sign informed consent form; 2. Burn patients, subjects who need autologous skin graft; 3. Patients aged from 18 to 65 years old, regardless of gender; 4. During this clinical study, the donor site was selected from the lateral thigh or trunk for treatment; 5. Patients with skin burn area less than 30% of total body surface area (TBSA); 6. The donor site was the first time, and the donor site was medium thickness (about 0.4mm thick); 7. The area of skin graft is 90cm2; 8. Patients who can cooperate with this study plan should receive regular postoperative visits.
Exclusion criteria
Exclusion criteria: 1. Allergic to alginate (gel); 2. Patients with electrical injury, chemical burn, radiation injury or combined with other trauma; 3. Subjects with severe systemic diseases (determined by the researcher); 4. Patients with unstable hypertension and diabetes mellitus (determined by the researcher); 5. Pregnant or lactating women; 6. The patient's condition may affect the study evaluation or need to combine medical treatment that may affect the evaluation of efficacy; 7. Patients with acute or chronic kidney disease, renal failure or serum creatinine level = 1.5 times the upper limit of normal value; 8. In patients with acute or chronic liver disease, the total bilirubin, alanine aminotransferase and aspartate aminotransferase in liver function = 2.0 times of the upper limit of normal value; 9. Subjects with a history of malignant tumor; 10. Patients who have participated in other clinical studies for less than 3 months; 11. Patients with mental illness, lack of insight and unable to express exactly; 12. Patients with immunosuppressants and long-term (more than 1 month) use of corticosteroids (excluding local application); 13. Subjects with infectious diseases (positive for any of the four infectious diseases); 14. Patients with other severe systemic diseases; 15. Subjects that other researchers thought could not be selected.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Wound healing time;Wound healing rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Postoperative wound infection;The degree of inflammation at the edge of wound;Subjective pain level;Degree of scar hyperplasia of wound; | — |
Countries
China
Contacts
Public ContactXia Chengde
Zhengzhou First People's Hospital
Outcome results
None listed