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Floseal hemostatic matrix
Floseal hemostatic matrix is a Hemostatic agent Small molecule drug developed by Chang Gung Memorial Hospital. It is currently FDA-approved for Hemostasis during surgical procedures where bleeding control is needed, Adjunctive hemostatic agent in general, cardiac, and vascular surgery. Also known as: Floseal.
FloSeal is a hemostatic matrix that combines gelatin and thrombin to form a biologically active scaffold that promotes rapid clot formation and hemostasis at surgical bleeding sites.
Floseal hemostatic matrix is used to control bleeding during laparoscopic cholecystectomy in acute cholecystitis and as a treatment for epistaxis. The exact mechanism of action of Floseal is unknown.
At a glance
| Generic name | Floseal hemostatic matrix |
|---|---|
| Also known as | Floseal |
| Sponsor | Chang Gung Memorial Hospital |
| Drug class | Hemostatic agent |
| Target | Thrombin-mediated fibrin formation |
| Modality | Small molecule |
| Therapeutic area | Hemostasis / Surgical bleeding control |
| Phase | FDA-approved |
Mechanism of action
FloSeal works by providing a three-dimensional gelatin matrix that is cross-linked with thrombin, a key coagulation enzyme. When applied to bleeding surfaces, the gelatin matrix absorbs blood and concentrates coagulation factors while thrombin directly catalyzes fibrin formation, accelerating the natural clotting cascade. This dual mechanism creates a stable clot that adheres to the wound site and is gradually absorbed as healing progresses.
Approved indications
- Hemostasis during surgical procedures where bleeding control is needed
- Adjunctive hemostatic agent in general, cardiac, and vascular surgery
Common side effects
- Allergic reaction
- Infection at surgical site
- Hematoma formation
- Seroma
Key clinical trials
- Evaluation of Hemostatic Agents in Partial Nephrectomy (NA)
- Management of Persistent Epistaxis Using Floseal Hemostatic Matrix (NA)
- Collagen-thrombin Matrix Efficacy During Cardiac Surgery: a Prospective Randomized Controlled Trial (PHASE4)
- Combined Topical Tranexamic Acid With Floseal® in Total Knee Arthroplasty (PHASE4)
- Prospective Pilot Study of Floseal for the Treatment of Anterior Epistaxis in Patients With (HHT) (NA)
- Blood-saving Effect of Combined Intravenous Tranexamic Acid With Topical Floseal® Application Total Hip Arthroplasty (PHASE4)
- Clinical Study Evaluating the Performance of HEMOBLAST Bellows Compared to FLOSEAL Hemostatic Matrix in Cardiothoracic Operations (NA)
- Evaluation of Hemostatic Agents in Robotic-assisted Laparoscopic Partial Nephrectomy (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Floseal hemostatic matrix CI brief — competitive landscape report
- Floseal hemostatic matrix updates RSS · CI watch RSS
- Chang Gung Memorial Hospital portfolio CI
Frequently asked questions about Floseal hemostatic matrix
What is Floseal hemostatic matrix?
How does Floseal hemostatic matrix work?
What is Floseal hemostatic matrix used for?
Who makes Floseal hemostatic matrix?
Is Floseal hemostatic matrix also known as anything else?
What drug class is Floseal hemostatic matrix in?
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What does Floseal hemostatic matrix target?
Related
- Drug class: All Hemostatic agent drugs
- Target: All drugs targeting Thrombin-mediated fibrin formation
- Manufacturer: Chang Gung Memorial Hospital — full pipeline
- Therapeutic area: All drugs in Hemostasis / Surgical bleeding control
- Indication: Drugs for Hemostasis during surgical procedures where bleeding control is needed
- Indication: Drugs for Adjunctive hemostatic agent in general, cardiac, and vascular surgery
- Also known as: Floseal
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing