Liver Hemorrhage Clinical Trial
— TSFHROfficial title:
A Randomized Controlled Trial to Compare the Efficacy of Traumastem® Versus Surgicel® for the Secondary Treatment of Local Bleeding in Patients Undergoing Hepatic Resection
| Verified date | October 2018 |
| Source | China Medical University, China |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 81 |
| Est. completion date | October 21, 2018 |
| Est. primary completion date | June 12, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility |
Inclusion Criteria: - Inpatient with informed consent - Adults aged between 18 to 75 and do not plan to have child within 1 year after the surgery - Resection of at least the equivalent tissue volume of 1 anatomical segment of the liver - Minor to moderate (oozing/diffuse) bleeding from the incisal area after conventional resection procedure and primary control of arterial pulsating bleeding or major venous hemorrhage by sutures, ligations, vascular clips, or point electrocautery Exclusion Criteria: - Indication for emergency surgery - Participate in other clinical trials in the past 3 months - Obvious hematologic disorder (as judged by the investigator from anemia and coagulation dysfunction) - Patients with brain disease, abnormal judgment or mental disorder that does not cooperate with the researcher - Patients with asthma or allergies - Patients with severe cardiac disease, metabolic disease or endocrine disorders - Immunodeficient patients (AIDS) - Pregnancy, breastfeeding females - Skin infection in the field of the targeted incisional area |
| Country | Name | City | State |
|---|---|---|---|
| China | Hepatobiliary Surgery Department of the First Hosptial of China Medical University | Shenyang | Liaoning |
| Lead Sponsor | Collaborator |
|---|---|
| China Medical University, China |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Hemostatic time | Hemostatic time began to calculate when gauze was applied. | 10 minutes | |
| Secondary | Postoperative drainage volume | Drainage volume through the site | In the first day after surgery | |
| Secondary | Postoperative drainage time | The duration of drainage | Up time to removal of wound drain, an expected average of 1 week | |
| Secondary | Hospital stay | Total hospital stay | Up time to discharge from hospital,an expected average of 3 weeks | |
| Secondary | Postoperative hospital stay | Total postoperative hospital stay | Up time to discharge from hospital,an expected average of 2 weeks |