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Completed

NCT Number: NCT03489070

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.

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Key information

Conditions

Liver Hemorrhage

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hepatobiliary Surgery Department of the First Hosptial of China Medical University

Shenyang, Liaoning, 110001, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Traumastem®

Combination Product

Intraoperative application as secondary hemostatic treatment

Surgicel®

Combination Product

Intraoperative application as secondary hemostatic treatment

Primary outcomes

  1. Hemostatic time

    Time frame: 10 minutes

    Hemostatic time began to calculate when gauze was applied.

Secondary outcomes

  1. Postoperative drainage volume

    Time frame: In the first day after surgery

    Drainage volume through the site

  2. Postoperative drainage time

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

    The duration of drainage

  3. Hospital stay

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

    Total hospital stay

  4. Postoperative hospital stay

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

    Total postoperative hospital stay

Sponsors and collaborators

Lead sponsor

China Medical University, China

Other

Registry information

Official study 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

Acronym: TSFHR

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 5, 2018
Registry last updated
Oct 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.