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| Name | Class |
|---|---|
| The Catholic University of Korea | OTHER |
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The wound healing efficacy and safety of "Medifoam H" in patients with minor, acute trauma.
The hypothesis of this study is that using "Medifoam H" dressing for a week is not inferior to using "Duoderm THIN" dressing in wound healing.
This study is single-center, randomized, active-controlled, open-label, Phase IV to evaluate clinical efficacy of wound healing and safety of "Medifoam H" in patients with minor, acute trauma.
33 patients of treatment group and 33 patients of control group, total 66 patients will be enrolled to this study. Every patient will be treated with "Medifoam H" or "Duoderm THIN" for a week. During their participation, patients will visit 2 days and a week after to see investigator. Investigator will observe the wound and evaluate amount of exudation, infection status, wound healing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medifoam H | Experimental | A group which treated with "medifoam H" on the wound. |
|
| Duoderm THIN | Active Comparator | A group which treated with " Duoderm THIN " on the wound |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medifoam H dressing | Device | Cover "medifoam H" on the wound for a week. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Wound healing rate according to amount of exudation at 1 week from baseline. If exudation is not existed, this will be defined as recovery | Wound healing rate according to amount of exudation at 1 week from baseline. If exudation is not existed, this will be defined as recovery. Exudation will be scored in 4 level: None/Mild/Normal/Severe. | 0 to 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of infection on wound | Rate of infection on wound. Infection means pus, erythema or tenderness and this will be judged by observation of investigator and scored in 3 level: not present/minimally present/extensively present. | 1/3/7 days. |
| Amount of exudation at day 3. |
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Inclusion Criteria:
1. Who has acute trauma(Laceration, Abrasion, Stitched wound, under superficial second-degree burn etc.)who satisfies at least 1 condition between followings:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jong-Won Rhie, MD.,PhD | Seoul St. Mary's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul St. Mary's Hospital | Seoul | Seoul | South Korea |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| Duoderm THIN dressing |
| Device |
Cover "Duoderm THIN" on the wound for a week |
|
Amount of exudation at day 3 from baseline. If exudation is not existed, this will be defined as recovery. Exudation will be scored in 4 level: None/Mild/Normal/Severe |
| 3 days |
| Rate of wound healing | Rate of wound healing at day 3 and 7 from baseline. Would healing will be scored in 3 level: Better/Same/Worse. | 3/7 days |
| Rate of changes in tissue after treatment | Rate of changes in tissue after treatment at day 3 and 7 from baseline. Changes in tissue will be recorded as percentage. Necrotic, sloughy, fibrous, granulation, epithelial, other tissues will be observed | 3/7 days |
| Whether use of concomitant medication or not | Whether use of concomitant medication or not | 1/3/7 days |