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Topical hemostats are agents that stop bleeding by contributing blood to clot. Oxidized cellulose, a sort of mechanical hemostatic material, predominantly forms a block to stop the blood flow and provides a surface to clot more rapidly.It was marketed for the first time in 1945 and widely used for its convenience, biocompatibility, and bactericide from that time. It is currently available in many commercial products, while manufactured using either a regenerated or nonregenerated process. The physicochemical property and hemostatic efficacy of oxidized regenerated cellulose (ORCG) and oxidized nonregenerated cellulose (ONRCG) has been well documented using in vitro test and animal models, and ONRCG was seemingly superior to ORCG in terms of hemostasis. However, no clinical study has been performed to verify. Therefore, the objective of this prospective randomized study is to assess the hemostatic efficacy of ORCG (Surgicel®, Ethicon) vs ONRCG (Traumastem®, Bioster) for hemostasis of local bleeding in patients undergoing hepatic resection.
Representative liver resected surface (prominent bleeding site) was applied the ply of gauze with several seconds of even finger gentle press under aseptic conditions, then it was untouched and observed for 10 min. Vascular occlusion of the liver was allowed if necessary, but was open for evaluation of hemostatic efficacy. Hemostatic time began to calculate when gauze was applied. Time to hemostasis was recorded in seconds and the maximum time to hemostasis was 600 seconds. Hemostasis success was achieved based on there was no visible bleeding or minimal ooze from the resection wound.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Traumastem® | Active Comparator | Oxidized nonregenerated cellulose hemostatic agents.Traumastem® absorbable patches, applied topically, once, intraoperatively to stop bleeding.The patches are used on the wound surface of the liver. |
|
| Surgicel® | Active Comparator | Oxidized regenerated cellulose hemostatic agents.Surgicle® absorbable patches, applied topically, once, intraoperatively to stop bleeding.The patches are used on the wound surface of the liver. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Traumastem® | Combination Product | Intraoperative application as secondary hemostatic treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hemostatic time | Hemostatic time began to calculate when gauze was applied. | 10 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative drainage volume | Drainage volume through the site | In the first day after surgery |
| Postoperative drainage time | The duration of drainage |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jialin Zhang, Ph.D/MD | First Hospital of China Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hepatobiliary Surgery Department of the First Hosptial of China Medical University | Shenyang | Liaoning | 110001 | China |
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| ID | Term |
|---|---|
| C013695 | Surgicel |
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| Surgicel® | Combination Product | Intraoperative application as secondary hemostatic treatment |
|
| Up time to removal of wound drain, an expected average of 1 week |
| Hospital stay | Total hospital stay | Up time to discharge from hospital,an expected average of 3 weeks |
| Postoperative hospital stay | Total postoperative hospital stay | Up time to discharge from hospital,an expected average of 2 weeks |