What SURGIFLO Treats: Main Uses and Benefits

The primary function of SURGIFLO is to serve as an adjunctive aid for supportive bleeding management during surgery, helping to manage specific types of hemorrhage that conventional methods may not adequately address.

This approach is commonly used across a wide range of surgical disciplines, including cardiovascular, neurosurgical, general soft tissue, and urological procedures, to help manage the symptom of persistent oozing. This is particularly relevant in clinical settings that involve acute or unstable symptom patterns where managing capillary and venular bleeding by conventional procedures may be insufficient. Supporting the quick resolution of this bleeding contributes to easing the overall symptom load by supporting reduced blood loss during the procedure.

In practical terms, the product is applied in situations where bleeding occurs in anatomically irregular, deep-seated, or difficult-to-access locations, such as during minimally invasive or complex spinal surgeries. This targeted action is relevant for easing symptoms related to postoperative fluid leakage and drainage in certain applications.

Quick Fact: Relevant for Symptomatic Management of Persistent Oozing

Regulatory References

1. U.S. Food and Drug Administration (FDA) summary review memo

Who Can and Cannot Use Surgiflo® Hemostatic Matrix: Official Regulatory Information

Eligibility for the use of Surgiflo is strictly defined by government regulatory documentation, primarily through a set of mandatory exclusions and restrictions related to the patient, the anatomical site, and the clinical condition.

Contraindications and Exclusions

Use is contraindicated and the product must not be used in patients with a known allergy to porcine gelatin, which is a primary component of the matrix. The matrix is also strictly prohibited from being used in intravascular compartments due to the risk of embolism, and it must not be used for closure of skin incisions as it may interfere with wound healing.

Populations with Use Restrictions

Official labeling identifies several populations and conditions where the safety or effectiveness has not been established:

Additionally, the matrix must be used with caution in contaminated areas and should not be left in or near delicate structures like the spinal cord, optic nerve, or ureters once hemostasis is achieved, due to the risk of swelling and potential nerve damage or calculus formation.

Interactions with other medicines and products

This section outlines the formally documented interaction profile for SURGIFLO (Flowable Gelatin Matrix with Human Thrombin), based strictly on government regulatory documents, such as the FDA Prescribing Information.

Documented Procedural Restrictions

As an adjunctive topical hemostat, the official interaction profile for SURGIFLO is defined by specific prohibitions on co-administration with other materials and technologies within the surgical field. These restrictions are classified as formal constraints on use, not traditional systemic drug-drug interactions.

SURGIFLO must not be used in conjunction with autologous blood salvage circuits. Additionally, the product must not be used in conjunction with methylmethacrylate adhesives. These restrictions define the primary interaction-related constraints for its use.

Undocumented Systemic Interactions

The regulatory documentation contains no official statements regarding systemic drug-drug interactions, which aligns with the product's localized, topical application. Therefore, no information is documented regarding:

• Pharmacokinetic Interactions: No CYP-mediated or transporter-based interactions are formally documented.
• Timing Restrictions: No mandatory time separation rules are formally documented.
• Food, Alcohol, or Supplements: No interactions are formally documented with food, alcohol, or supplements.

The physiological consequences of Surgiflo application are mediated through two primary, non-molecular mechanisms: passive mechanical occlusion and active biochemical matrix provision. The flowable, porcine-derived gelatin matrix is applied directly to the bleeding tissue, where it conforms to irregular surface contours. The physical presence of the gelatin aggregate provides a local tamponade effect, leading to the mechanical obstruction of blood flow from compromised microvasculature. Simultaneously, the porous structure of the gelatin polymer serves as a topographical scaffold for the passive capture and selective accumulation of circulating cellular components, notably platelets. This concentration of platelets facilitates their adherence and aggregation, initiating the endogenous coagulation cascade. When combined with exogenous thrombin, this component acts as an enzyme, converting soluble fibrinogen into the insoluble monomer fibrin. Fibrin monomers then spontaneously polymerize, cross-linking to form the stable fibrin clot. This dual-cascade potentiation accelerates the local formation of the definitive hemostatic plug, resulting in systemic physiological modulation characterized by cessation of blood egress from the targeted tissue.

Administration Guidelines

SURGIFLO Hemostatic Matrix is intended for use exclusively as an adjunctive topical hemostat in supervised surgical settings. Its use is determined by the specific need within the surgical field, rather than by a fixed or scheduled dosage regimen.

Administration Scope

Preparation and Handling

The product requires a specific preparation process by healthcare professionals immediately prior to its application. This includes the sterile reconstitution and mixing of the components (gelatin matrix and thrombin solution). The gelatin matrix component is mixed with the thrombin solution using a specific technique, typically involving pushing the contents between two syringes a total of 6 times to ensure uniform, flowable consistency.

Following application, the protocol requires that any excess matrix must be removed from the site once hemostasis is achieved. The applied material is designed to be absorbed by the body completely within 4 to 6 weeks. The prepared mixture remains usable for up to 8 hours after mixing.

Evidence for Use in Surgical Bleeding Control

The evidence base for SURGIFLO was developed through systematic reviews and large-scale retrospective observational studies, which explored patterns of measurement related to its use as a supportive agent for managing minor surgical bleeding, specifically capillary and venular oozing. Studies monitored key indicators of hemostasis, or the process of stopping blood flow, during the surgical procedure itself.

Studies Focused on High-Volume Surgical Fields (Spinal and Cardiovascular Procedures)

Research has concentrated on adult patients undergoing complex procedures. Large cohorts in Spinal Surgery and Cardiovascular Surgery were monitored, with studies reporting measurements of time-to-hemostasis patterns observed in these specialized surgical populations.

Evidence on Healthcare Resource Outcomes

In addition to bleeding control, studies were evaluated for outcomes related to resource use, including Operating Room (OR) time and Length of Hospital Stay (LOS). Research also monitored rates of blood transfusion. Data show patterns related to resource utilization between groups studied, though some earlier measurements reported varying results.

Long-Term Follow-up and Durability Data

Follow-up durations for primary efficacy endpoints were intraoperative. Clinical outcomes like readmission rates and mortality were observed over short-term intervals (e.g., 30, 60, and 90 days post-surgery). However, long-term effects beyond the three-month period are not fully established, and limited information exists on the durability of the hemostatic effect.

Research in Special Patient Populations

Research primarily explored various adult populations. Regulatory evidence notes that the product was not evaluated in research involving pediatric patients or pregnant women. Results apply only to the populations studied, and data are still emerging regarding applicability to these special groups.

What Remains Uncertain About the Research

A key limitation is the reliance on large retrospective observational studies, which carry an inherent risk of bias, as these studies are not randomized. Evidence quality varies across studies. Specifically, the absence of robust, randomized, controlled clinical studies in certain specialized areas, such as US neurosurgery, is noted in the regulatory findings. Research is ongoing to address these areas of uncertainty.

Key Studies & References

1. Real-World Economic and Clinical Outcomes Associated with Current Hemostatic Matrix Use in Cardiovascular Surgery
2. A systematic revision and meta-analysis of hemostatic matrices for bleeding control

Common questions about Surgiflo (FAQ)

Q: How quickly does Surgiflo stop bleeding in surgery?

Studies conducted as part of the regulatory approval process monitored patterns related to how quickly Surgiflo helps stop bleeding, a measurement called time-to-hemostasis. Some data, primarily from animal models, indicated that the combination product of Surgiflo with Thrombin achieved hemostasis in less than a minute. Regulatory descriptions highlight that the flowable matrix is intended to accelerate the natural clotting process at the application site.

Q: Why do surgeons use flowable hemostats like Surgiflo instead of traditional gauze?

Surgiflo is intended as an adjunctive hemostat, meaning it is used to supplement conventional methods, such as sutures or cautery. Its flowable nature, unlike some traditional materials, is designed to conform precisely to irregular surgical contours, maximizing contact. The product is intended as an adjunct when standard methods are impractical or ineffective in controlling minor bleeding.

Q: Can Surgiflo be used in minimally invasive procedures?

Yes, official product descriptions and marketing materials indicate that Surgiflo can be used in various surgical procedures, including those that are minimally invasive. The product can be delivered and applied using specialized applicators designed for use in narrow operative fields, such as in laparoscopic surgery.

Q: Are there any long-term studies on the effects of Surgiflo?

Official reports on the product focus on short-term outcomes. Clinical results such as readmission and mortality were observed over intervals like 30, 60, and 90 days following surgery. Regulatory evidence notes that the long-term effects beyond the initial three-month period have not been fully established.

Q: Does the application of Surgiflo affect wound healing?

Surgiflo is strictly for internal use during surgery and is not intended for the surface of the skin. Official labeling states the product is contraindicated (must not be used) for the closure of skin incisions because its presence may interfere with the healing of skin edges.

Q: Is there a possibility of infection related to the use of Surgiflo?

Regulatory information indicates a need for caution. Gelatin-based hemostatic agents have been reported to potentially serve as a site for infection or abscess formation. Therefore, the official use guidelines place constraints on its use, stating that the product is not to be used in the presence of infection and only with caution in contaminated areas.

Q: Is Surgiflo biodegradable?

Official product information states that the gelatin matrix component is absorbable. It is designed to be fully absorbed by the body, a process that is generally complete within four to six weeks after application.

Q: Does Surgiflo interact with surgical sealants or glues?

Official regulatory warnings prohibit the co-administration of Surgiflo with specific materials. Specifically, the product must not be used in conjunction with Methylmethacrylate Adhesives, which is a type of bone cement or glue.

Q: Has Surgiflo been recalled for any safety issues?

Records from regulatory databases that track device safety events show that the product has been subject to some recalls. These have typically been Class II recalls, which are often related to issues with packaging or labeling, not a direct product safety failure when used as intended.

Q: Does using Surgiflo reduce the need for blood transfusions?

Studies evaluated health resource outcomes, including monitoring rates of blood transfusion. However, regulatory documents do not provide a definitive conclusion stating that the product consistently reduces the need for transfusions.

Q: Is Surgiflo used in dental procedures or just major surgery?

The official indication states that Surgiflo is for use in surgical procedures (other than ophthalmic) to help control bleeding. This general indication means its use is not restricted only to major surgery and can include applications in other surgical fields.

Q: Are there different sizes or types of Surgiflo available?

The product is supplied as a kit that prepares a standard final volume of 8 mL of the flowable matrix. The product is available in formulations with and without an added thrombin component.

Q: What is the maximum amount of Surgiflo that can be safely used in one surgery?

The official principle for administration is that healthcare professionals should use only the minimum amount of the matrix necessary to achieve bleeding control. A key safety constraint is that any excess product must be removed from the site once hemostasis is complete.

Q: Can Surgiflo be used on bone surfaces to stop bleeding?

Surgiflo is indicated for bleeding from capillaries, small veins, and small arteries, including within surgical procedures that involve bone. However, official warnings state the material must be removed from or near any openings in the bone (foramina) due to the risk of swelling, which could lead to compression injury to nearby nerves.

Q: Is Surgiflo used in neurosurgery?

While the product is used in various surgical fields, regulatory findings specifically note the absence of robust, randomized, controlled clinical studies in the United States to prove its safe and effective use in neurosurgery.

Q: Does Surgiflo cause tissue inflammation?

In laboratory animal studies, tissue reactions were classified as minimal. However, official information documents that adverse events, including giant cell granulomas and foreign body reactions, have been observed with absorbable gelatin-based hemostatic agents.

Q: Is it possible for Surgiflo to migrate from the application site?

The regulatory label documents that rare, serious adverse events have been reported due to the migration of the material. This occurs when the material moves into critical areas, such as nerve openings in the bone or the eye orbit, causing a risk of compression injury.

Q: Is Surgiflo used in cardiac surgery?

The evidence base includes research that monitored the product’s performance in large groups of adult patients undergoing complex procedures, including those classified as Cardiovascular Surgery.

Q: What is the role of the powder component in Surgiflo?

The powder component is the Absorbable Porcine Gelatin Matrix, which is mixed before use to create the flowable gel. The matrix provides a physical scaffold that helps obstruct blood flow and facilitates the adherence of the body’s platelets, which helps initiate the natural clotting process.

Official Storage and Disposal Requirements

Regulatory labeling dictates specific conditions for storing and handling Surgiflo, which is supplied as a sterile, single-use product.

Storage Conditions

Stability and Disposal

The prepared Flowable Gelatin Matrix must be used within eight hours of mixing, provided it remains within the sterile field. Surgiflo is for single use only. Unused open pouches and excess materials must be immediately discarded according to healthcare facility protocols for non-reusable medical waste.