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

October 22, 2018 updated by: Jialin Zhang, China Medical University, China

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
81

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Hemostatic time
Time Frame: 10 minutes
Hemostatic time began to calculate when gauze was applied.
10 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Postoperative drainage volume
Time Frame: In the first day after surgery
Drainage volume through the site
In the first day after surgery
Postoperative drainage time
Time Frame: Up time to removal of wound drain, an expected average of 1 week
The duration of drainage
Up time to removal of wound drain, an expected average of 1 week
Hospital stay
Time Frame: Up time to discharge from hospital,an expected average of 3 weeks
Total hospital stay
Up time to discharge from hospital,an expected average of 3 weeks
Postoperative hospital stay
Time Frame: Up time to discharge from hospital,an expected average of 2 weeks
Total postoperative hospital stay
Up time to discharge from hospital,an expected average of 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
China Medical University, China

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jialin Zhang, Ph.D/MD, First Hospital of China Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 15, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 12, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 21, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 24, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 29, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 5, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 23, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 22, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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