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

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

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.

Study Overview

• Status: Completed
• Conditions: Liver Hemorrhage
• Intervention / Treatment: Combination product: Surgicel®; Combination product: Traumastem®

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.

• Study Type: Interventional
• Enrollment (Actual): 81
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Liaoning
    • Shenyang, Liaoning, China, 110001
      • Hepatobiliary Surgery Department of the First Hosptial of China Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Combination product: Surgicel®; Intraoperative application as secondary hemostatic treatment
Active Comparator: 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.	Combination product: Traumastem®; Intraoperative application as secondary hemostatic treatment

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: China Medical University, China
• Investigators: Principal Investigator: Jialin Zhang, Ph.D/MD, First Hospital of China Medical University

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2017
• Primary Completion (Actual): June 12, 2018
• Study Completion (Actual): October 21, 2018

Study Registration Dates

• First Submitted: March 24, 2018
• First Submitted That Met QC Criteria: March 29, 2018
• First Posted (Actual): April 5, 2018

Study Record Updates

• Last Update Posted (Actual): October 23, 2018
• Last Update Submitted That Met QC Criteria: October 22, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Liver resection; Liver Hemorrhage; Traumastem; Surgicel
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage
• Other Study ID Numbers: Absorbable hemostatic gauze

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No