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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Traumacel FAM Trium | Experimental | Randomized application haemostatic agent Traumacel FAM Trium in the bleeding site. |
|
| Surgicel Fibrillar | Active Comparator | Randomized application of haemostatic agent Surgicel Fibrillar in the bleeding site. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Traumacel FAM Trium | Device | Absorbable Hemostat (oxidized non-regenerated cellulose) |
|
| 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 |
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Hradec Králové | Hradec Králové | 50005 | Czechia |
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| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D000072836 | Surgical Wound |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014947 | Wounds and Injuries |
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| Surgicel Fibrillar | Device | Absorbable Hemostat (oxidized regenerated cellulose) |
|
| Number of subjects with complications during surgery. |
| During a surgical procedure, an average of 1 hour |
| Occurrence of adverse events. | 1 month |