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The objective of this study is to collect the hemostatic effectiveness and device safety data of "HANBIO" Gauze in subjects have acute wound result from gynecology surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| "HANBIO" Gauze | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| "HANBIO" Gauze (Sterilized, 1% Collagen) | Device | After tissue resection in a standard procedure for gynecological surgery, direct application of "HANBIO" Gauze to cover the bleeding site/area which identified during dissection. |
| Measure | Description | Time Frame |
|---|---|---|
| Average Time(sec) to achieve hemostasis | The mean time(seconds) required to achieve hemostasis following the application of "HANBIO" Gauze. | 3 min |
| Measure | Description | Time Frame |
|---|---|---|
| Proportions of subjects achieving hemostatic success at 3 min. | Subjects achieved success hemostasis within or at 3 minutes following the application of "HANBIO" Gauze. | 3 min |
| Number/proportion of adverse and serious adverse events. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Taipei | Taiwan |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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Subjects had AE or SAE following the application of "HANBIO" Gauze.
| 3 min |
| Ease of use questionnaire of Product "HANBIO" Gauze (by Principal Investigator) | Five questions regarding conveniency, non-adhesive property, conformability and hemostatic efficacy of "HANBIO" Gauze will be evaluated by surgeon(PI). One description, from "very satisfied", "satisfied", "neutral", "unsatisfied", "very unsatisfied", will be selected for each question. | 3 min |