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

NCT03489070 | Completed Phase 3 DMC

• 1 other identifier: Absorbable hemostatic gauze
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Hemorrhage

Keywords

Liver resection; Liver Hemorrhage; Traumastem; Surgicel

Outcome Measures

Primary Outcomes (1)

• Hemostatic time

  Hemostatic time began to calculate when gauze was applied.

  10 minutes

Secondary Outcomes (4)

• Postoperative drainage volume

  In the first day after surgery

• Postoperative drainage time

  Up time to removal of wound drain, an expected average of 1 week

• Hospital stay

  Up time to discharge from hospital,an expected average of 3 weeks

• Postoperative hospital stay

  Up time to discharge from hospital,an expected average of 2 weeks

Study Arms (2)

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.

Combination Product: Surgicel®

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.

Combination Product: Traumastem®

Interventions

Traumastem® COMBINATION_PRODUCT

Intraoperative application as secondary hemostatic treatment

Surgicel®

Surgicel® COMBINATION_PRODUCT

Intraoperative application as secondary hemostatic treatment

Traumastem®

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• China Medical University, China: lead

Study Sites (1)

Hepatobiliary Surgery Department of the First Hosptial of China Medical University

Shenyang, Liaoning, 110001, China

Location

MeSH Terms

Interventions

Surgicel

Study Officials

• Jialin Zhang, Ph.D/MD

  First Hospital of China Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Hepatobiliary Surgery Department, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: March 24, 2018
• First Posted: April 5, 2018
• Study Start: August 15, 2017
• Primary Completion: June 12, 2018
• Study Completion: October 21, 2018
• Last Updated: October 23, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)