Traumacel FAM Trium in the Post-market Surveillance Phase

NCT05177874 | Completed

• 1 other identifier: PMCF-29-11-19
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bleeding; Surgical Wound

Keywords

Oxidized cellulose; Haemostatic agent

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Number of subjects in whom haemostasis was achieved within 2 minutes after administration.

  2 minutes

• Degree of bleeding from target bleeding site

  10 minutes

• Number of subjects with complications during surgery.

  During a surgical procedure, an average of 1 hour

• Occurrence of adverse events.

  1 month

Study Arms (2)

Traumacel FAM Trium

EXPERIMENTAL

Randomized application haemostatic agent Traumacel FAM Trium in the bleeding site.

Device: Traumacel FAM Trium

Surgicel Fibrillar

ACTIVE COMPARATOR

Randomized application of haemostatic agent Surgicel Fibrillar in the bleeding site.

Device: Surgicel Fibrillar

Interventions

Traumacel FAM Trium DEVICE

Absorbable Hemostat (oxidized non-regenerated cellulose)

Also known as: Traumastem FAM Trium, EMOXICEL FAM Trium, Traumastem Fibrillar, Celstat Fibrillar

Traumacel FAM Trium

Surgicel Fibrillar DEVICE

Absorbable Hemostat (oxidized regenerated cellulose)

Surgicel Fibrillar

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bioster, a.s.: lead

Study Sites (1)

University Hospital Hradec Králové

Hradec Králové, 50005, Czechia

Location

MeSH Terms

Conditions

Hemorrhage; Surgical Wound

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2021
• First Posted: January 5, 2022
• Study Start: May 18, 2020
• Primary Completion: January 2, 2021
• Study Completion: January 2, 2021
• Last Updated: January 5, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)