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

NCT ID: NCT03489070

Last Updated: 2018-10-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-15
• Study Completion Date: 2018-10-21

Brief Summary

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

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.

Conditions

Liver Hemorrhage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Traumastem®

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.

Group Type: ACTIVE_COMPARATOR

Surgicel®

Intervention Type: COMBINATION_PRODUCT

Intraoperative application as secondary hemostatic treatment

Surgicel®

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.

Group Type: ACTIVE_COMPARATOR

Traumastem®

Intervention Type: COMBINATION_PRODUCT

Intraoperative application as secondary hemostatic treatment

Interventions

Traumastem®

Intraoperative application as secondary hemostatic treatment

Intervention Type: COMBINATION_PRODUCT

Surgicel®

Intraoperative application as secondary hemostatic treatment

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China Medical University, China

OTHER

Sponsor Role: lead

Responsible Party

Jialin Zhang

Director of Hepatobiliary Surgery Department, Principal Investigator, Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jialin Zhang, Ph.D/MD

Role: PRINCIPAL_INVESTIGATOR

First Hospital of China Medical University

Locations

Hepatobiliary Surgery Department of the First Hosptial of China Medical University

Shenyang, Liaoning, China

Countries

China

Other Identifiers

Absorbable hemostatic gauze

Identifier Type: -

Identifier Source: org_study_id