Traumastem® Versus Surgicel® for the Secondary Treatment of Local Bleeding in Patients Undergoing Hepatic Resection

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomized Controlled Trial to Compare the Efficacy of Traumastem® Versus Surgicel® for the Secondary Treatment of Local Bleeding in Patients Undergoing Hepatic Resection

Conditions
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Liver Hemorrhage

Intervention / Treatment
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* Combination Product: Traumastem®
* Combination Product: Surgicel®


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Traumastem®<br>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. | Combination Product: Surgicel®<br>* Intraoperative application as secondary hemostatic treatment<br>|
| Active Comparator: Surgicel®<br>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. | Combination Product: Traumastem®<br>* Intraoperative application as secondary hemostatic treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemostatic time | Hemostatic time began to calculate when gauze was applied. | 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Liver resection, Liver Hemorrhage, Traumastem, Surgicel