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| Name | Class |
|---|---|
| Equilab International | UNKNOWN |
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This study is a prospective study, randomized, using control, open-label, single-center to evaluate the efficacy and safety of EASYEF® in acute wound (split-thickness skin graft donor site). A total of 10 subjects are randomly allocated. Subjects who meet the final inclusion and exclusion criteria are randomized to the test cohorts in a ratio of 1:1:1.
This study was intended to determine the effect of EGF on acute wounds such as trauma, surgical wounds and burns. But in this study, skin graft donor site wounds were used because they were the most representative for acute wounds and the depth and extent of the wounds could be controlled. EGF is known pharmacologically to accelerate epithelial cell proliferation, fibroblast cells and endothelial cells. Giving EGF in acute wounds is expected to accelerate wound healing and improve patient quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Active Comparator |
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| Cohort 2 | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rhEGF | Drug | EASYEF® spray 50 mcg, sprayed twice a day for 14 days. |
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| Measure | Description | Time Frame |
|---|---|---|
| Comparison of the wound healing time of each skin graft donor site | The definition of 'wound healing' is when there is no more exudate in the skin graft donor and the skin is covered with epithelial tissue in a milky light pink color and there is no pain. Healing time (morning or afternoon) evaluation and pain scale (11-point NRS (Numeric Rating Scale); 0 = No pain, 5 = Moderate pain, and 10 = Worst possible pain) will be assessed. | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | In order to confirm the adverse events (AE), it is confirmed through the questionnaire of investigators and the physical examination. If an adverse event occurs, record the timing of the adverse event, the duration, the extent of the adverse event, and the causal relationship. | 14 days |
| Photograph evaluation |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RSPAD Gatot Soebroto | Central Jakarta | DKI Jakarta | 10410 | Indonesia |
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During the change of dressing in the morning and evening, photograph was taken to evaluate the re-epithelization improvement. |
| 14 days |