Back to resultsTraumastem® Versus Surgicel® for the Secondary Treatment of Local Bleeding in Patients Undergoing Hepatic Resection (TSFHR)
Primary Purpose
Liver Hemorrhage
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Traumastem®
Surgicel®
Sponsored by
About this trial
This is an interventional treatment trial for Liver Hemorrhage focused on measuring Liver resection, Liver Hemorrhage, Traumastem, Surgicel
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
Sites / Locations
- Hepatobiliary Surgery Department of the First Hosptial of China Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Traumastem®
Surgicel®
Arm 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.
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.
Outcomes
Primary Outcome Measures
Hemostatic time
Hemostatic time began to calculate when gauze was applied.
Secondary Outcome Measures
Postoperative drainage volume
Drainage volume through the site
Postoperative drainage time
The duration of drainage
Hospital stay
Total hospital stay
Postoperative hospital stay
Total postoperative hospital stay
Full Information
NCT ID
NCT03489070
First Posted
March 24, 2018
Last Updated
October 22, 2018
Sponsor
China Medical University, China
1. Study Identification
Unique Protocol Identification Number
NCT03489070
Brief Title
Traumastem® Versus Surgicel® for the Secondary Treatment of Local Bleeding in Patients Undergoing Hepatic Resection
Acronym
TSFHR
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
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
August 15, 2017 (Actual)
Primary Completion Date
June 12, 2018 (Actual)
Study Completion Date
October 21, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
China Medical University, China
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Hemorrhage
Keywords
Liver resection, Liver Hemorrhage, Traumastem, Surgicel
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
81 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Traumastem®
Arm Type
Active Comparator
Arm 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.
Arm Title
Surgicel®
Arm Type
Active Comparator
Arm 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.
Intervention Type
Combination Product
Intervention Name(s)
Traumastem®
Intervention Description
Intraoperative application as secondary hemostatic treatment
Intervention Type
Combination Product
Intervention Name(s)
Surgicel®
Intervention Description
Intraoperative application as secondary hemostatic treatment
Primary Outcome Measure Information:
Title
Hemostatic time
Description
Hemostatic time began to calculate when gauze was applied.
Time Frame
10 minutes
Secondary Outcome Measure Information:
Title
Postoperative drainage volume
Description
Drainage volume through the site
Time Frame
In the first day after surgery
Title
Postoperative drainage time
Description
The duration of drainage
Time Frame
Up time to removal of wound drain, an expected average of 1 week
Title
Hospital stay
Description
Total hospital stay
Time Frame
Up time to discharge from hospital,an expected average of 3 weeks
Title
Postoperative hospital stay
Description
Total postoperative hospital stay
Time Frame
Up time to discharge from hospital,an expected average of 2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jialin Zhang, Ph.D/MD
Organizational Affiliation
First Hospital of China Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hepatobiliary Surgery Department of the First Hosptial of China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110001
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Traumastem® Versus Surgicel® for the Secondary Treatment of Local Bleeding in Patients Undergoing Hepatic Resection
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