TachoSil® Fibrin Sealant Patch is a collagen patch coated with physiologic coagulation factors. It has unique mechanical, hemostatic, and occulsive properties and can therefore be used in a wide range of open and minimally invasive surgical procedures. With fibrinogen and thrombin, TachoSil® mimics the last part of the physiologic coagulation cascade. Hemostasis and sealing in one – with prove efficacy and safety.
Closed-Cell Collagen Matrix
TachoSil is a fixed combination of a collagen matrix coated with the active human coagulation factors fibrinogen and thrombin.
Proven Effective in Cardiovascular Surgery
The ability of TachoSil patch to control bleeding in cardiovascular surgery was evaluated in an open-label, 1:1 randomized, parallel-group study comparing TachoSil® patch with a comparator treatment.
Bleeding was controlled at 3 minutes in approximately 75% of patients treated with TachoSil patch.1
Proven Effective in Hepatic Surgery
The ability of TachoSil patch to control bleeding in hepatic resection surgery was evaluated in a randomized, open label, parallel-group, multi-center trial to compare the efficacy and safety of TachoSil versus a standard treatment.* ITT population = 224 patients.
Bleeding was controlled at 3 minutes in approximately 81% of patients treated with TachoSil patch.2
Benefits
Improves hemostasis
Air and liquid tight closed cell collagen matrix
Supports sutures in vascular surgery
Unparalleled plyability
Clinically applicable in pediatric cases (for patients >1 month of age)
How to apply TachoSil®
1
Open aluminum blister
The cover film can be removed outside the sterile zone.
2
Open plastic blister
Peel off the cover film in the sterile zone with sterile gloves.
3
Grasp
Remove the fleece from the sterile packaging with forceps.
4
Trim (optional)
Important: TachoSil® should extend 1-2 cm beyond the edge of the wound.
5
Moisten (optional)
If the wound is dry, moistening before application is recommended. If the wound is wet, TachoSil® can be dry when applied.
6
Apply
Apply with the yellow active side facing the wound. If multiple fleeces are used, overlap them like roof tiles.
7
Press in place
Press in place slightly for at least 3-5 minutes, ideally with a moist compress.
8
Remove the compress
Remove carefully, using forceps if necessary.
1
Open aluminum blister
The cover film can be removed outside the sterile zone.
2
Open plastic blister
Peel off the cover film in the sterile zone with sterile gloves.
3
Grasp
Remove the fleece from the sterile packaging with forceps.
4
Trim (optional)
Important: TachoSil® should extend 1-2 cm beyond the edge of the wound.
5
Moisten (optional)
If the wound is dry, moistening before application is recommended. If the wound is wet, TachoSil® can be dry when applied.
6
Apply
Apply with the yellow active side facing the wound. If multiple fleeces are used, overlap them like roof tiles.
7
Press in place
Press in place slightly for at least 3-5 minutes, ideally with a moist compress.
8
Remove the compress
Remove carefully, using forceps if necessary.
Indications & important risk information
Do not apply Tachosil® fibrin sealant patch intravascularly. Intravascular application of Tachosil® can result in life-threatening thromboembolic events. Thrombosis can occur if Tachosil® is exposed intravascularly. Ensure that Tachosil® is applied to the surface of cardiac, vascular or hepatic tissue only.
Do not use Tachosil® in individuals with known hypersensitivity to human blood products or horse proteins.
Can cause hypersensitivity or allergic/anaphylactoid reactions with first-time or repetitive application.
Avoid application to contaminated areas of the body or in the presence of active infection.
Tachosil® contains collagen which may adhere to bleeding surface. May carry a risk of gastrointestinal obstruction in abdominal surgery due to tissue adhesions. To prevent the development of tissue adhesions at undesired sites, ensure tissue areas outside the application area are adequately cleansed before administration of Tachosil®. Avoid packing in cavities or closed spaces because this may cause compression of underlying tissue. Use the least number of patches required to cover the entire bleeding area. Do not pack. Remove any unattached pieces of Tachosil® fibrin sealant patch.
May carry a risk of transmitting infectious agents, such as viruses, and theoretically, the variant Creutzfeldt-Jakob disease (vCJD) agent and the Creutzfeldt-Jakob disease (CJD) agents, despite manufacturing steps designed to reduce the risk of viral transmission.
The most common adverse reactions reported in >1% of patients during clinical trials were anemia, nausea and vomiting, fever, abdominal pain, increased white blood cell count, ascites, itching, atrial fibrillation, pleural effusion, gastrointestinal hemorrhage, wound infection, hypophosphatemia, urinary tract infection and post-procedural bile leakage in hepatic surgery.
Indications
Indicated for use with manual compression in adult and pediatric patients as an adjunct to hemostasis in cardiovascular and hepatic surgery when control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical.
Not for use in place of sutures or other forms of mechanical ligation in treatment of major arterial or venous bleeding. Not for use in children under one month of age.
Full Prescribing Information
https://corza.com/wp-content/uploads/2023/01/6027464_1829_10_TachoSil-LFT-USA-clean.pdf
Unsolicited Request for Off-Label Use
https://forms.zohopublic.com/corzamedical/form/UnsolicitedRequestsforOffLabelInformation/formperma/O6YtaJvqzuMzP9qo0rmyACFbfTBamP3uGoGg5K9M5ls
1. (Maisano F, et al. TachoSil surgical patch versus conventional haemostatic fleece material for control of bleeding in cardiovascular surgery: a randomised controlled trial. Eur J Cardiothorac Surg. 2009 Oct;36(4):708-14.)
2. Genyk Y, Kato T, Pomposelli JJ, Wright JK Jr, Sher LS, Tetens V, Chapman WC. Fibrin Sealant Patch (TachoSil) vs Oxidized Regenerated Cellulose Patch (Surgicel Original) for the Secondary Treatment of Local Bleeding in Patients Undergoing Hepatic Resection: A Randomized Controlled Trial. J Am Coll Surg. 2016 Mar;222(3):261-8. doi: 10.1016/j.jamcollsurg.2015.12.007. Epub 2015 Dec 18.