What is SURGIFOAM? A Porcine Gelatin Hemostat
SURGIFOAM is a medical device, restricted by federal law to be sold by or on the order of a physician. It is made from sterile, water-insoluble, malleable porcine (pig-derived) gelatin. This off-white, porous material is intended for hemostatic use, meaning it helps to stop or prevent bleeding. The product, manufactured by Ethicon, a Johnson & Johnson company, has been a staple in surgical bleeding management for over 60 years.
SURGIFOAM is available in two main forms: a sponge and a powder. The sponge can be cut to a specific size and shape, while the powder can be mixed into a paste or slurry for easier application to irregular surfaces. This versatility allows surgeons to tailor the product to the specific needs of a bleeding site. The most important characteristic is its absorbability; the body naturally breaks down and absorbs the gelatin over time, eliminating the need for removal and minimizing tissue reaction.
Mechanism of Action: How SURGIFOAM Promotes Hemostasis
The hemostatic properties of SURGIFOAM are primarily achieved through two key mechanisms: mechanical and biological. When applied to a bleeding surface, the material acts as a physical barrier that helps to mechanically slow down the flow of blood. Its porous, sponge-like structure also serves as a crucial matrix for the body's natural clotting process.
- Mechanical Tamponade: The sponge or powder material absorbs blood and other fluids, causing it to swell and exert pressure on the bleeding vessels. This physical compression, known as tamponade, helps to reduce blood flow and initiate clot formation. The sponge can absorb up to 40 times its weight in blood.
- Biological Matrix: The gelatin matrix attracts platelets from the blood. Platelets adhere to and aggregate within the sponge's structure. This aggregation, combined with the concentration of clotting factors at the bleeding site, accelerates the formation of a stable fibrin clot. This process is enhanced when the sponge is saturated with thrombin, a natural enzyme that plays a key role in the coagulation cascade.
Uses and Applications in Surgery
SURGIFOAM is indicated for use in surgical procedures where conventional methods like pressure or ligation are ineffective or impractical. It has a broad range of applications across multiple surgical disciplines. The key applications include:
- General Surgery: Management of bleeding from capillaries, small veins, and arterioles in soft tissue and organs.
- Dental and Oral Surgery: Used in procedures such as tooth extractions and removal of impacted teeth to control bleeding.
- Neurosurgery: Applied to control bleeding in spinal and cranial procedures, though specific precautions are required due to swelling.
- Urologic Surgery: Used in various procedures, with care taken to remove excess material to prevent calculus formation.
- Cardiovascular Surgery: Assists with hemostasis during procedures on the heart and blood vessels.
Important Contraindications and Precautions
While highly effective, SURGIFOAM has specific contraindications and requires precautions to be used safely.
Contraindications
- Skin Incisions: Do not use for closure of skin incisions, as the presence of gelatin can interfere with the healing process.
- Intravascular Compartments: Never apply intravascularly due to the significant risk of embolization, which can cause life-threatening clots in blood vessels.
- Porcine Allergies: Individuals with known allergies to porcine collagen should not be treated with SURGIFOAM.
- Infected Sites: The product should not be used in the presence of an active infection.
- Arterial Hemorrhage: Not intended for controlling severe arterial bleeding with rapid, high-pressure flow.
- Primary Treatment: Not a substitute for proper surgical technique or for the primary treatment of coagulation disorders.
Precautions
- Avoid Overpacking: When placed in a cavity or confined space, overpacking can cause compression and swelling, potentially leading to nerve damage.
- Remove Excess: Any excess material not needed for hemostasis should be carefully removed to prevent potential complications.
- Sterile Use: The product is supplied sterile and cannot be resterilized. Unused portions must be discarded after opening.
- Autologous Blood Salvage: Do not use with blood salvage circuits, as fragments can pass through transfusion filters.
- Limited Application: Safety and effectiveness have not been established for ophthalmic procedures, post-partum bleeding, or menorrhagia.
SURGIFOAM vs. Other Hemostatic Agents
SURGIFOAM is one of several topical hemostatic agents. Below is a comparison with other common options, specifically other absorbable gelatin products.
| Feature | SURGIFOAM | Gelfoam | Floseal/Surgiflo |
|---|---|---|---|
| Composition | Porcine gelatin | Porcine gelatin | Bovine gelatin with human or bovine thrombin |
| Form | Sponge and powder | Compressed sponge | Flowable gel/matrix |
| Mechanism | Mechanical tamponade & matrix for clotting | Mechanical tamponade & matrix for clotting | Mechanical tamponade & active coagulation enhancement |
| Application | Dry or saturated with saline/thrombin | Dry, or wet with saline/thrombin | Mixed and applied via syringe |
| Absorption Time | 4-6 weeks (2-5 days on mucosa) | 4-6 weeks (2-5 days on mucosa) | Absorbed in approximately 5 weeks |
| Best For | General, controlled bleeding | General, controlled bleeding | Irregular surfaces, wet fields |
| Contraindications | Skin incisions, intravascular, porcine allergy | Intravascular, porcine allergy | Skin incisions, intravascular, bovine/human protein allergy |
Potential Adverse Effects
Clinical studies have identified potential adverse effects associated with absorbable porcine gelatin hemostatic agents like SURGIFOAM. While many are common and manageable, some rare but serious complications have been reported.
Common Adverse Events
In a clinical trial, the most frequently reported adverse events (occurring in over 5% of patients) included:
- Fever
- Tachycardia (rapid heartbeat)
- Asthenia (weakness)
- Peripheral edema (swelling of extremities)
- Nausea
- Pain
- Anemia
Rare but Serious Complications
- Neurologic Damage: Compression of the brain or spinal cord due to swelling, especially if used near foramina or in confined bone spaces.
- Embolism: Clot formation within the bloodstream if accidentally introduced intravascularly.
- Infection: Gelatin can serve as a potential nidus for infection or abscess formation, particularly in contaminated areas.
- Granulomas: Formation of inflammatory tissue masses (giant cell granulomas) at the implant site, primarily reported in cerebral applications.
- Foreign Body Reactions: Prolonged fixation of tendons or other foreign body reactions at implant sites.
Conclusion
SURGIFOAM is a trusted and versatile hemostatic agent that plays a critical role in surgical bleeding management. By providing a sterile, absorbable, porcine gelatin matrix, it effectively supports the body's natural clotting process in cases where conventional methods are insufficient. Its availability in different forms (sponge and powder) and its ability to be used with or without thrombin allow for flexible application in numerous surgical procedures. However, adherence to strict contraindications and precautions—particularly those related to confined spaces and intravascular use—is essential to maximize safety and prevent potentially serious adverse effects, including nerve damage, embolism, or infection.
For more detailed information, consult the FDA's instructions for use for the SURGIFOAM sponge(https://www.accessdata.fda.gov/cdrh_docs/pdf/P990004c.pdf).
