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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| low-dose stem cell gel group | Experimental | The gel was applied as the inner dressing evenly to the wound surface. To ensure a uniform and thick application, the dosage of the gel used in each group was kept consistent. A medical surgical film was used as the outer dressing, and a layer of gauze was wrapped on the outermost layer. The gel dressing was used on the day of the surgery, the 3rd day after the surgery, and the 7th day after the surgery. During each dressing change, the dressing was opened layer by layer and carefully removed, and the residual stem cell gel was washed off with sterile normal saline. |
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| high-dose stem cell gel group | Experimental |
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| with only the gel | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| low-dose stem cell gel group | Combination Product | 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 |
| 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 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Xinxiang Medical College | Recruiting | Xinxiang | Henan | 453000 | China |
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| ID | Term |
|---|---|
| D002056 | Burns |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| high-dose stem cell gel group | Combination Product | 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 |
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| with only the gel | Other | Using only hydrogels as wound dressings to promote wound healing in burn patients after thick skin grafting |
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