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This study is a randomized, controlled, multi-centre, open-label, phase IV study.
Total 81 patients will be enrolled in this study. Patients will be randomly assigned to Betafoam®, petrolatum gauze or Allevyn for donor site wounds after skin graft operation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Betafoam Wound Dressing | Experimental | This contains 3% povidone iodine. Dressing will be routinely changed on day 3 and day 7, and can be replaced anytime due to various factors such as exudate control, dislodgement, or by investigators' clinical decision. |
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| Petrolatum Gauze | Active Comparator | Dressing will be routinely changed on day 3 and day 7 and can be replaced anytime due to various factors such as exudate control, dislodgement, or by investigators' clinical decision. |
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| Allevyn Wound Dressing | Active Comparator | Allevyn adhesive wound dressing will be routinely changed on day 3 and day 7 and can be replaced anytime due to various factors such as exudate control, dislodgement, or by investigators' clinical decision. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Betafoam Wound Dressing | Device | Foam dressing including Betadine iodine |
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| Measure | Description | Time Frame |
|---|---|---|
| Efficacy as measured by speed of wound healing | Days needed for complete skin epithelialization in donor site wounds through routine swab culture (1 and 3 days) and visual assessment of wounds | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy as measured by adverse event collection | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jongwon Lee, Dr. | Seoul St. Mary's Hospital, The Catholic University of Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul St. Mary's Hospital | Seoul | 137-701 | South Korea |
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| Petrolatum Gauze | Device | Gauze dressing |
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| Allevyn Wound Dressing | Device | Foam dressing |
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