Burn Injury, Burn Patients
Conditions
Brief summary
Burn patients were randomly divided into the low-dose stem cell gel group, the high-dose stem cell gel group, and the placebo group (with only the gel), and received the same treatment under the same conditions simultaneously.
Detailed description
This study adopted a randomized, double-blind, parallel-controlled research method. It planned to enroll 90 burn patients who underwent autologous thick skin transplantation. These patients were randomly divided into the low-dose stem cell gel group, the high-dose stem cell gel group, and the placebo group (with only the gel), with 30 patients in each group. The three groups of subjects received the same treatment under the same conditions simultaneously.
Interventions
COMBINATION_PRODUCTlow-dose stem cell gel group
Using hydrogels containing low-doses of placenta-derived mesenchymal stem cells as wound dressings to promote wound healing in burn patients after thick skin grafting
COMBINATION_PRODUCThigh-dose stem cell gel group
Using hydrogels containing or without differenthigh-doses of placenta-derived mesenchymal stem cells as wound dressings to promote wound healing in burn patients after thick skin grafting
OTHERwith only the gel
Using only hydrogels as wound dressings to promote wound healing in burn patients after thick skin grafting
Sponsors
The First Affiliated Hospital of Xinxiang Medical College
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Voluntary participation and signing of the informed consent form; 2. Burn patients, subjects requiring autologous skin grafting; 3. Age 18 to 65 years old, gender not restricted; 4. During this clinical study, single person, single donor skin area (lateral thigh or trunk) treatment; 5. Skin burn area \< 30% of total body surface area (TBSA); 6. The donor skin area is the first time for donation, and the donor skin area is medium-thick skin (thickness approximately 0.4mm); 7. The area of the excised skin flap ≥ 90 cm2; 8. Able to cooperate with this study protocol and accept regular postoperative follow-up visits.
Exclusion criteria
1. Those allergic to sodium alginate (gel component); 2. Electric shock injuries, chemical burns, radiation injuries or combined with other traumas; 3. Subjects with severe systemic diseases (judged by the researchers); 4. Subjects with uncontrolled hypertension or diabetes (judged by the researchers); 5. Pregnant or lactating women; 6. Subjects whose condition may affect the study assessment or require the concurrent use of medical treatments that may affect the efficacy assessment; 7. Subjects with acute or chronic kidney diseases, renal failure or serum creatinine level = 1.5 times the upper limit of normal value; 8. Subjects with acute or chronic liver diseases, total bilirubin, alanine aminotransferase, aspartate aminotransferase = 2.0 times the upper limit of normal value; 9. Subjects with a history of malignant tumors; 10. Subjects who have participated in other clinical studies for less than 3 months; 11. Subjects with mental disorders and without self-awareness, unable to express clearly; 12. Subjects using immunosuppressants and those who have been using corticosteroids for a long time (more than 1 month) (excluding local application); 13. Subjects with infectious diseases (any one of the four items positive in the test); 14. Subjects with other severe systemic diseases; 15. Other subjects that the researchers consider not eligible for inclusion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Re-epithelialization areas | Up to 6 month | Re-epithelialization will be determined by clinical evaluations and recorded by digital color photographs |
| Complete burn wound healing | Up to 12 month | Time (days) to complete re-epithelialization of burned skin. It will be based on clinical evaluations and digital color photographs |
Countries
China
Contacts
CONTACTWenjie Ren
Outcome results
None listed