Traumacel FAM Trium in the Post-market Surveillance Phase

Multicentric, Prospective, Controlled, Randomised Clinical Study of the Device Traumacel FAM Trium in the Post-market Surveillance Phase

The investigational medical device Traumacel FAM Trium is a sterile plant polysaccharide haemostatic agent based on the oxidized cellulose in the form of multilayer nonwoven fabric. It is used as an adjunct to stop capillary, venous, or small arterial bleeding, and also to prevent early postoperative bleeding. It can be used in all areas of stopping diffuse bleeding from resection surfaces such as parenchymatous organs, muscles or defined body cavities. The wide scope of application allows the use for classical, robotic surgery and endoscopic treatments (e.g. laparoscopic).

The main objective of the study is to compare the efficacy and safety of Traumacel FAM Trium and regenerated oxidized cellulose based fibrous haemostat when used in accordance with their intended purpose. The partial objectives are: identification of any previously unknown side-effects and monitoring of known side-effects; identification and analysis of potentially newly emerging risks; confirmation of the acceptability of the benefit-risk ratio; identification of any systematic misuse of the device or off-label use of the device in order to verify the correctness of its intended purpose.

Study Overview

• Status: Completed
• Conditions: Bleeding; Surgical Wound
• Intervention / Treatment: Device: Traumacel FAM Trium; Device: Surgicel Fibrillar

• Study Type: Interventional
• Enrollment (Actual): 98
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Hradec Králové, Czechia, 50005
    • University Hospital Hradec Kralove

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Minimum age of 18.
• Surgical intervention.
• Negative pregnancy test of women in fertile age.
• Diffuse soft tissue, vascular or parenchymal haemorrhage after conventional surgical haemostatic methods have not worked or are impractical (e.g. ligation, suture, compression, cauterisation).
• Informed consent

Exclusion Criteria:

• Hypersensitivity or a known reaction to oxidized cellulose.
• Age under 18
• A severe clinical condition of the patient (e.g. associated illness, mental disorder) which, according to the investigator, could adversely affect patient safety and/or compliance with the procedures used in the study.
• The patient has participated in another clinical study involving a haemostatic product within 30 days prior to enrolment, or another such clinical study is planned during the subject's participation in the study.
• Pregnancy or lactation.
• If during the procedure itself, there was no need to use the test agent
• Application of any other topical haemostatic product prior to application of the test agent to the same site.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Traumacel FAM Trium; Randomized application haemostatic agent Traumacel FAM Trium in the bleeding site.	Device: Traumacel FAM Trium; Absorbable Hemostat (oxidized non-regenerated cellulose); Other Names: Traumastem FAM Trium; EMOXICEL FAM Trium; Traumastem Fibrillar; Celstat Fibrillar
ACTIVE_COMPARATOR: Surgicel Fibrillar; Randomized application of haemostatic agent Surgicel Fibrillar in the bleeding site.	Device: Surgicel Fibrillar; Absorbable Hemostat (oxidized regenerated cellulose)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time required to achieve haemostasis.	10 minutes
Number of subjects in whom haemostasis was achieved within 3 minutes after administration.	3 minutes
Number of subjects who required surgical revision within 12 hours after the procedure for recurrent bleeding.	12 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Degree of bleeding from target bleeding site	10 minutes
Number of subjects in whom haemostasis was achieved within 2 minutes after administration.	2 minutes
Number of subjects with complications during surgery.	During a surgical procedure, an average of 1 hour
Occurrence of adverse events.	1 month

Collaborators and Investigators

• Sponsor: Bioster, a.s.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 18, 2020
• Primary Completion (ACTUAL): January 2, 2021
• Study Completion (ACTUAL): January 2, 2021

Study Registration Dates

• First Submitted: December 1, 2021
• First Submitted That Met QC Criteria: December 15, 2021
• First Posted (ACTUAL): January 5, 2022

Study Record Updates

• Last Update Posted (ACTUAL): January 5, 2022
• Last Update Submitted That Met QC Criteria: December 15, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Oxidized cellulose; Haemostatic agent
• Additional Relevant MeSH Terms: Wounds and Injuries; Surgical Wound
• Other Study ID Numbers: PMCF-29-11-19

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