Clinical trial NCT05177874: Traumacel FAM Trium in the Post-market Surveillance Phase
Official title: Multicentric, Prospective, Controlled, Randomised Clinical Study of the Device Traumacel FAM Trium in the Post-market Surveillance Phase
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bleeding
Surgical Wound
Keywords: Oxidized cellulose
Haemostatic agent
Lead sponsor: Bioster, a.s.
Sponsor class: INDUSTRY
First posted: 2022-01-05
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Time required to achieve haemostasis.
timeFrame: 10 minutes
measure: Number of subjects in whom haemostasis was achieved within 3 minutes after administration.
timeFrame: 3 minutes
measure: Number of subjects who required surgical revision within 12 hours after the procedure for recurrent bleeding.
timeFrame: 12 hours
Secondary outcomes:
measure: Number of subjects in whom haemostasis was achieved within 2 minutes after administration.
timeFrame: 2 minutes
measure: Degree of bleeding from target bleeding site
timeFrame: 10 minutes
measure: Number of subjects with complications during surgery.
timeFrame: During a surgical procedure, an average of 1 hour
measure: Occurrence of adverse events.
timeFrame: 1 month
Other outcomes:
Locations:
city: Hradec Králové
country: Czechia
facility: University Hospital Hradec Králové
Study officials:
References: