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

China Medical University, China

Status and phase: Completed; Phase 3

Conditions: Liver Hemorrhage

Treatments: Combination Product: Surgicel®; Combination Product: Traumastem®

Study type: Interventional

Funder types: Other

Identifiers

NCT03489070

Absorbable hemostatic gauze

Details and patient eligibility

About

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.

Full 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.

Enrollment: 81 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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81 participants in 2 patient groups

Traumastem®

Active Comparator group

Description:

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.

Treatment:

Combination Product: Surgicel®

Surgicel®

Active Comparator group

Description:

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.

Treatment:

Combination Product: Traumastem®