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To evaluate the safety and tolerability of human umbilical cord mesenchymal stem cells combined with bovine type I collagen in the treatment of third-degree burn wounds.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combination Therapy Group | Experimental | Bovine type I collagen sponge + human umbilical cord mesenchymal stem cells (HUMSCs) |
|
| Collagen Control Group | Active Comparator | Bovine type I collagen sponge alone |
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| Placebo Group | Sham Comparator | Sterile blank dressing / Vaseline gauze |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HUMSCs combined with bovine type I collagen | Combination Product | To evaluate the safety and tolerability of human umbilical cord mesenchymal stem cells combined with bovine type I collagen in the treatment of third-degree burn wounds |
| Measure | Description | Time Frame |
|---|---|---|
| Re-epithelialization areas | Re-epithelialization will be determined by clinical evaluations and recorded by digital color photographs | Up to 6 month |
| Complete burn wound healing | Time (days) to complete re-epithelialization of burned skin. It will be based on clinical evaluations and digital color photographs | Up to 12 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wenjie Ren | Contact | 13937354075 | 13937354075@163.com | |
| Wenjie Ren | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Wenjie Ren | The First Affiliated Hospital of Xinxiang Medical College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Xinxiang Medical College | Recruiting | Xinxiang | Henan | China |
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| ID | Term |
|---|---|
| D002056 | Burns |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| bovine type I collagen | Biological | To evaluate the safety and tolerability of bovine type I collagen in the treatment of third-degree burn wounds |
|
| Sterile blank dressing / Vaseline gauze | Device | To evaluate the safety and tolerability of sterile blank dressing / vaseline gauze in the treatment of third-degree burn wounds. |
|