Bleeding, Surgical Wound
Conditions
Keywords
Oxidized cellulose, Haemostatic agent
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.
Interventions
DEVICETraumacel FAM Trium
Absorbable Hemostat (oxidized non-regenerated cellulose)
DEVICESurgicel Fibrillar
Absorbable Hemostat (oxidized regenerated cellulose)
Sponsors
Bioster, a.s.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| 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
| Measure | Time frame |
|---|---|
| Number of subjects in whom haemostasis was achieved within 2 minutes after administration. | 2 minutes |
| Occurrence of adverse events. | 1 month |
| 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 |
Countries
Czechia
Outcome results
None listed