Traumacel FAM Trium in the Post-market Surveillance Phase

Bleeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05177874
• Other study ID #: PMCF-29-11-19
• Status: Completed
• Phase: N/A
• Start date: May 18, 2020
• Est. completion date: January 2, 2021

Study information

• Verified date: December 2021
• Source: Bioster, a.s.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: January 2, 2021
• Est. primary completion date: January 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bleeding
• Surgical Wound

Intervention

Device:
• Traumacel FAM Trium
Absorbable Hemostat (oxidized non-regenerated cellulose)
• Surgicel Fibrillar
Absorbable Hemostat (oxidized regenerated cellulose)

Locations

Country	Name	City	State
Czechia	University Hospital Hradec Králové	Hradec Králové

Sponsors (1)

Lead Sponsor	Collaborator
Bioster, a.s.

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time required to achieve haemostasis.		10 minutes
Primary	Number of subjects in whom haemostasis was achieved within 3 minutes after administration.		3 minutes
Primary	Number of subjects who required surgical revision within 12 hours after the procedure for recurrent bleeding.		12 hours
Secondary	Number of subjects in whom haemostasis was achieved within 2 minutes after administration.		2 minutes
Secondary	Degree of bleeding from target bleeding site		10 minutes
Secondary	Number of subjects with complications during surgery.		During a surgical procedure, an average of 1 hour
Secondary	Occurrence of adverse events.		1 month