What Floseal Hemostatic Matrix Treats: Main Uses and Benefits

Floseal is commonly used as an auxiliary agent to support the management of active blood loss during surgery when traditional methods are ineffective or impractical. This therapeutic use is relevant for managing a range of symptoms related to physical discomfort from blood loss, including fine capillary and venous oozing and more pronounced localized spurting on bone and soft tissue. The product is relevant for symptom management in contexts involving specialized surgical domains, including cardiovascular, neurologic, and orthopedic settings.

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Managing Complex Bleeding and Patient Support

It may assist with managing diffuse surface bleeding and hemorrhage in complex anatomical settings, such as deep surgical tracts or irregular resection surfaces where other materials cannot conform. By supporting the management of these disruptive manifestations, Floseal supports the management of symptoms that create noticeable physiological strain. This is particularly relevant in high-risk scenarios, including heart surgery patients who may be fully heparinized.

“Its localized application provides supportive relief to help address temporary clotting challenges at the surgical site.”

This application contributes to easing the overall burden related to blood loss and supports the management of bleeding in these challenging contexts.

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Quick Fact: Uses and Benefits
Primary Use Context	Adjunctive hemostasis in surgical procedures.
Symptom Patterns	Oozing, spurting, and diffuse capillary bleeding.
Patient Benefit	May assist with maintaining functional stability during procedures.

Who Can and Cannot Use Floseal Hemostatic Matrix?

This information is based strictly on official government regulatory documents (e.g., FDA Prescribing Information) and defines the product's official eligibility status.

Floseal Hemostatic Matrix is intended for prescription use only as an adjunct to hemostasis in surgical procedures, excluding ophthalmic use.

Absolute Prohibitions (Contraindications)

Individuals must not use this product if they have known allergies to materials of bovine origin (due to the gelatin component) or a history of hypersensitivity to the thrombin component or any constituent proteins (e.g., hamster proteins).

Eligibility and Site Restrictions

Certain surgical applications and patient conditions prohibit or restrict use:

• Vascular Use: Must not be injected or compressed into blood vessels, nor applied when blood flow is clamped or absent, due to the risk of clotting.
• Closure of Skin Incisions: Use is not allowed for closing skin edges.
• Coagulation Disorders: Must not be used as the primary treatment for underlying bleeding or coagulation disorders.
• Infection: Should be avoided in the presence of active infection.

Use Not Established (Insufficient Data)

Safety and effectiveness have not been established in the following populations:

• Pediatric Patients: Children under 2 years of age.
• Pregnant Women: Use is restricted to situations where it is clearly needed.

The official interaction profile for Floseal Hemostatic Matrix is structured around local material and chemical incompatibilities and specific immunological constraints, which is typical for a topically applied combination product. Systemic pharmacokinetic interactions, such as those involving metabolic enzymes or transporters, are not documented in the regulatory labeling.

Category	Official Interaction Constraints
Physical Incompatibilities	Co-use with methylmethacrylate or other acrylic adhesives on bone surfaces is prohibited, as the gelatin component can reduce the adhesive material's strength.
Chemical Incompatibilities	The application site must be cleaned to remove antiseptic solutions containing alcohol, iodine, or heavy metal ions before Floseal is applied, because these substances chemically denature the thrombin component.
Immunological Restrictions	Use is contraindicated in patients with known allergies to materials of bovine origin. Prior exposure to bovine thrombin products can lead to antibody formation, which may result in systemic Factor V deficiency upon re-exposure.
Co-administration Data	The regulatory safety and effectiveness of the combined use with antibiotic solutions or powders has not been established.

These constraints define mandatory administration sequencing rules and formal prohibitions on co-location with specific surgical adjuncts. The overall structure reflects the necessity of preserving the chemical integrity of the active enzymatic component while managing immunological and material risks.

Floseal Hemostatic Matrix operates via a dual-mechanism system involving mechanical and chemical components. The mechanical component, consisting of cross-linked bovine gelatin granules, is applied to the site of hemorrhage. Upon contact with blood or other aqueous physiological fluid, these granules undergo volumetric expansion, swelling approximately 10–20% within ten minutes. This rapid swelling exerts a localized, physical tamponade effect upon the disrupted vascular tissue, physically restricting the flow of blood.

Simultaneously, the gelatin matrix serves as a localized, high-concentration delivery platform for the chemical component, human thrombin. Thrombin is a serine protease that acts as a direct enzyme agonist upon soluble fibrinogen present in the perfusing blood. This catalytic interaction cleaves specific peptides from the fibrinogen molecule, generating active fibrin monomers. These monomers spontaneously self-assemble via polymerization into an insoluble, stable fibrin polymer mesh. The fibrin polymer interlocks with the gelatin granules, structurally stabilizing the entire assembly. This downstream cascade culminates in the rapid formation of a stable, mechanically robust clot in situ, resulting in localized cessation of extravascular blood flow (hemostasis) at the macroscopic system level.

The Floseal Hemostatic Matrix is intended strictly for topical administration as an adjunct to hemostasis during surgery and must not be injected into blood vessels. Its use is governed by procedural and time-sensitive instructions for preparation and application.

The product is supplied in separate components—the Gelatin Matrix and the lyophilized Thrombin—which must be mixed prior to use using the provided 0.9% Sodium Chloride Solution. Once prepared, the flowable matrix has a designated usage window of up to 8 hours. Dosing is not based on a fixed volume but is determined by the size of the bleeding surface, requiring the surgeon to apply an adequate amount to ensure complete coverage of the tissue defect.

During administration, the material is typically held at the site with gentle compression for 2 minutes to allow for the initial formation of a stable clot. A critical procedural requirement is the mandatory removal of any excess material not integrated into the clot by gentle irrigation and suction. The application site must be free of antiseptics containing alcohol or iodine, which can inactivate the Thrombin component. The matrix will swell by 10–20% following application. Safety and effectiveness have not been established in children under 2 years of age or in neonates. The material is designed to be resorbed within 6 to 8 weeks.

Research evidence / Overview of studies for Floseal Hemostatic Matrix

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Evidence for use in Controlling Surgical Bleeding (Pivotal Trials)

Research has explored the use of the flowable gelatin matrix for hemostasis (controlling bleeding) in major surgeries where conventional methods are insufficient or difficult to apply. These pivotal studies was evaluated in Randomized Controlled Trials (RCTs), where patients were assigned by chance to receive the Floseal product or a standard comparator. The main outcome measured was the Time to achieve hemostasis, or the duration required to achieve a stable clot, typically measured within a few minutes.

Studies monitored patient groups undergoing significant operations, including cardiac surgery procedures, and also included patients who were fully heparinized (receiving a strong blood thinner). Findings describe patterns observed in the studies where the time needed to achieve hemostasis was measured and reported for both the Floseal group and the comparator group.

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Research on use in Spine Surgery and Hospital Resource Patterns

This section will review studies that assessed Floseal in the context of spine surgery, particularly focusing on the use of retrospective database analysis to measure health resource utilization outcomes, such as blood transfusion rates and hospital length of stay (LOS).

The evidence base related to spine surgery was evaluated in Retrospective Observational Studies that analyze large hospital databases. These observational studies explored outcomes related to systemic or functional imbalance, such as the need for blood transfusions and the patient's Hospital Length of Stay (LOS). Data show patterns related to these resource utilization metrics when comparing patients who received Floseal to those who received other treatments.

A key limitation here is that evidence quality varies across studies, and the design of retrospective analysis prevents establishing a direct, clear link between the product's use and the measured resource outcomes like LOS or surgical time. Results apply only to the populations studied.

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Areas of Research Uncertainty and Study Limitations

The evidence base for Floseal includes both Randomized Controlled Trials (RCTs) and retrospective studies. The use of large database analysis data show patterns related to Hospital Length of Stay and transfusion rates, but certainty remains low regarding a direct causal connection to the product's use.

In summary, findings show patterns related to immediate hemostasis outcomes, but follow-up durations were limited in many cases. The research provides context but not individual predictions, and subgroup findings are uncertain in specific populations like those continuously taking antiplatelet medications. Initial regulatory approvals noted that safety and effectiveness data are insufficient in children under two years of age.

Key Studies & References Use of a haemostatic matrix (Floseal®) does not reduce blood loss in minimally invasive total knee arthroplasty performed under continued aspirin

Common questions about Floseal Hemostatic Matrix (FAQ)

Q: How quickly is Floseal expected to stop the bleeding?

A: Official clinical trial data indicates that control of bleeding (hemostasis) was achieved in a median time of 1.5 minutes in studies involving spinal surgery. In pivotal clinical trials, the product was shown to stop bleeding in 96% of cases within 10 minutes. These results were observed in a controlled study setting and provide context for the product's performance.

Q: What happens if excess Floseal Matrix is left in the surgical site?

A: Regulatory instructions state that excess material not integrated into the clot must be removed by irrigation and suction to prevent potential complications. The regulatory instructions emphasize the need for meticulous removal of excess material. This is because the matrix swells, and if allowed to migrate near confined areas like the spinal cord, swelling has been associated with risks of neurological injury.

Q: Is Floseal appropriate for patients who are taking blood thinners (anticoagulants)?

A: Clinical studies included patients who were fully anticoagulated with heparin during cardiac procedures. Official regulatory documents, however, clearly state that Floseal is not intended to be used as the primary or sole treatment for underlying bleeding or coagulation disorders.

Q: Is Floseal Matrix safe to use near the brain or spinal cord?

A: Official warnings state that the use of the matrix near the brain, spinal cord, or cranial nerves requires the meticulous removal of any excess material. This strict instruction is due to the risk that material swelling or migration in these anatomically restricted areas could cause neurological injury.

Q: What are the long-term effects of Floseal being absorbed by the body?

A: The material is designed to be fully absorbed, or resorbed, by the body within 6 to 8 weeks, which is consistent with the timeframe of normal wound healing. However, some adverse event reports have described complications related to delayed absorption or a localized inflammatory reaction.

Q: Is the manufacturing process for Floseal designed to reduce the risk of viral transmission?

A: The manufacturing process for the human thrombin component includes viral reduction steps, such as vapor-heated and solvent/detergent treatments. These steps are specifically designed to reduce the risk of transmitting infectious agents, although regulatory documents note that no procedure is guaranteed to be completely effective.

Q: Do surgeons always have to remove Floseal if they use it in certain areas?

A: The Instructions for Use state that only the excess material—the portion of the matrix that has not successfully integrated into the hemostatic clot—must always be removed from the surgical site by gentle irrigation and suction.

Q: What kinds of procedures most commonly use Floseal Hemostatic Matrix?

A: Floseal is indicated for use in surgical procedures to control bleeding in tissues such as bone and soft tissue. Official labeling provides specific exclusions, such as ophthalmic, and certain neurosurgical and urological procedures.

Q: Can Floseal Matrix be used in all types of surgery?

A: Floseal is indicated for use in surgical procedures as an adjunct to hemostasis. However, official product labeling explicitly excludes its use in ophthalmic, and certain neurosurgical and urological procedures.

Q: Are there any religious or dietary concerns related to Floseal's ingredients?

A: Floseal contains components derived from both bovine (cow) materials (the gelatin matrix) and human plasma (the thrombin component). These components, which include bovine (cow) materials and human plasma, may be a factor to consider in light of specific religious or dietary restrictions.

Q: Has the use of Floseal been associated with complications like small bowel obstruction?

A: Adverse event case reports submitted to regulatory systems have described rare instances of complications like small bowel obstruction developing after Floseal use. These events are often associated with an intense localized inflammatory reaction and adhesion formation at the site of application.

Q: What types of bleeding, from oozing to spurting, is Floseal designed to control?

A: Official product labeling indicates that Floseal is designed to control a range of surgical bleeding. This includes low-level oozing up to more profuse spurting bleeding, provided that conventional surgical methods are ineffective or impractical for management.

Q: Does Floseal affect or interfere with blood tests like PT/PTT after surgery?

A: Regulatory adverse event data indicates that rare hematologic effects were observed in clinical trials. These included an increased activated partial thromboplastin time (aPTT) and a prolonged prothrombin time (PT).

Q: What should a patient know about the use of Floseal if they have a history of thrombosis (blood clots)?

A: Floseal is not intended to treat pre-existing coagulation disorders. Furthermore, regulatory warnings state that improper administration, such as injection into a blood vessel, carries a risk of severe, life-threatening thromboembolic events (clotting).

Q: Can the material in Floseal cause inflammation or scar tissue (adhesions)?

A: Regulatory documents list rare cases of local inflammation at the application site as an adverse event. Additionally, published case reports have described intense inflammatory reactions associated with the matrix material that may contribute to post-operative adhesion formation.

Q: Can Floseal cause fever or unexplained pain after the operation?

A: Fever and generalized pain are listed in regulatory documents as rare adverse events, occurring in 1% or less of patients in clinical trials. Pain may also be a localized symptom of device migration in specific areas, such as the spinal area.

How to Store and Dispose of Floseal Hemostatic Matrix?

The storage and handling of Floseal Hemostatic Matrix are governed by specific regulatory requirements to maintain the integrity of its components. The product must be stored at 2 °C to 25 °C (36 °F to 77 °F) and must not be frozen. It is essential to keep the product away from sunlight and store it in a dry environment, always remaining in its original packaging to preserve sterility.

Since the product is for single use only, it must not be re-sterilized. Specific time limits apply after preparation: the reconstituted Thrombin Solution is stable for up to four hours, and the final mixed FLOSEAL Matrix must be used within eight hours. Following use, the remaining solution, the Thrombin vial, and the vial adapter must be discarded appropriately according to institutional protocols.