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The purpose of this study is to evaluate the efficacy and safety of Mediclore®, as an antiadhesive barrier, which is made of Poloxamer, Gelatin and Chitosan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mediclore | Experimental | adhesion barrier Mediclore 5cc, to apply medical device fully around surgery area |
|
| No treatment | No Intervention | standard treatment for surgery | |
| Adept | Active Comparator | adhesion barrier, Adept, to apply medical device fully around surgery area |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mediclore | Device | apply medical device fully around intrauterine surgery area |
|
| Measure | Description | Time Frame |
|---|---|---|
| adhesion rate | 4 weeks after surgery, finding adhesion using visceral slide test | 4 weeks after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adhesion symptoms | 4 weeks after surgery, Identifying adhesion sysmptoms using Questionnaire | 4 weeks after surgery |
| adverse event | identifying adverse events after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yongsang Song, MD | Contact | +82-10-9580-1023 | yssong@snu.ac.kr | |
| Maria Lee, MD | Contact | +82-10-2991-9692 | marialee@snu.ac.kr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoutl National University Hospital | Recruiting | Seoul | South Korea |
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| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| ID | Term |
|---|---|
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| Adept | Device | apply medical device fully around intrauterine surgery area |
|
| 4 weeks after surgery |