Clinical trial NCT03489070: Traumastem® Versus Surgicel® for the Secondary Treatment of Local Bleeding in Patients Undergoing Hepatic Resection
Official title: A Randomized Controlled Trial to Compare the Efficacy of Traumastem® Versus Surgicel® for the Secondary Treatment of Local Bleeding in Patients Undergoing Hepatic Resection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Liver Hemorrhage
Keywords: Liver resection
Liver Hemorrhage
Traumastem
Surgicel
Lead sponsor: China Medical University, China
Sponsor class: OTHER
First posted: 2018-04-05
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Hemostatic time
timeFrame: 10 minutes
Secondary outcomes:
measure: Postoperative drainage volume
timeFrame: In the first day after surgery
measure: Postoperative drainage time
timeFrame: Up time to removal of wound drain, an expected average of 1 week
measure: Hospital stay
timeFrame: Up time to discharge from hospital,an expected average of 3 weeks
measure: Postoperative hospital stay
timeFrame: Up time to discharge from hospital,an expected average of 2 weeks
Other outcomes:
Locations:
city: Shenyang
country: China
facility: Hepatobiliary Surgery Department of the First Hosptial of China Medical University
state: Liaoning
Study officials:
affiliation: First Hospital of China Medical University
name: Jialin Zhang, Ph.D/MD
role: PRINCIPAL_INVESTIGATOR
References: