Traumacel FAM Trium in the Post-market Surveillance Phase

Study Overview
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Brief Summary
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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.

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

Conditions
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Bleeding, Surgical Wound

Intervention / Treatment
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* Device: Traumacel FAM Trium
* Device: Surgicel Fibrillar


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Traumacel FAM Trium<br>Randomized application haemostatic agent Traumacel FAM Trium in the bleeding site. | Device: Traumacel FAM Trium<br>* Absorbable Hemostat (oxidized non-regenerated cellulose)<br>* Other names: Celstat Fibrillar;|
| Active Comparator: Surgicel Fibrillar<br>Randomized application of haemostatic agent Surgicel Fibrillar in the bleeding site. | Device: Surgicel Fibrillar<br>* Absorbable Hemostat (oxidized regenerated cellulose)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oxidized cellulose, Haemostatic agent