NCT05177874

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: Bioster, a.s. · Industry
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	Traumacel FAM Trium	Absorbable Hemostat (oxidized non-regenerated cellulose)
DEVICE	Surgicel Fibrillar	Absorbable Hemostat (oxidized regenerated cellulose)

Timeline

• Start date: 2020-05-18
• Primary completion: 2021-01-02
• Completion: 2021-01-02
• First posted: 2022-01-05
• Last updated: 2022-01-05

Locations

1 site across 1 country: Czechia