What is Polysaccharide Hemostatic Powder Made From and How Does It Work?
Surgiclean® hemostat powder is derived from potato starch and processed through emulsification cross-linking technology to form multi-microporous microspheres. The final product is sterilized using ethylene oxide (EO).
Surgiclean® hemostat powder acts as a hydrophilic molecular sieve that rapidly absorbs and retains water several times its own weight, forming a gel that creates localized pressure on blood vessels to mechanically block bleeding. Simultaneously, by absorbing plasma, it concentrates cellular blood components such as platelets, red blood cells, and prothrombin at the bleeding site. This enrichment triggers the intrinsic coagulation cascade, accelerating clot formation and promoting hemostasis-typically achieved within just a few minutes.
How Does Surgiclean Compare to Competitors (e.g., Arista™, J&J Surgicel® ORC Powder)?
Surgiclean® and Arista™ are of the same product category, both using potato starch as the base material. Their application methods and hemostatic mechanisms are fundamentally the same.
J&J Surgicel® ORC Powder, however, is made from oxidized regenerated cellulose (ORC), processed into a powdered form via patented fiber technology. The resulting high surface area enhances its hemostatic performance and allows for better adaptability to various bleeding sites. ORC's highly acidic environment contributes antibacterial effects and stimulates vasoconstriction to aid in hemostasis. However, this acidity can also provoke localized inflammation, potentially delaying wound healing and irritating surrounding nerves. Moreover, ORC should not be used in combination with other hemostatic agents due to chemical compatibility concerns.
When Should Powder-Based Hemostats Be Preferred Over Fabric-Type Products?
Powder hemostats offer superior surface coverage and adhesion, making them ideal for irregularly shaped or deep and narrow bleeding sites. They are typically applied using nozzles or delivery tubes, providing access to hard-to-reach surgical areas.
In contrast, fabric-based products like Surgicel® (oxidized regenerated cellulose gauze) may offer antibacterial properties, but their acidic nature may cause inflammation and is less suited for non-flat, confined bleeding sites. Powder formulations provide better conformity and ease of use in complex surgical scenarios.
Clinical Evidence Supporting Surgiclean®
To assess the safety and efficacy of Surgiclean®, a multicenter, non-inferiority clinical study was conducted, using Arista™ as the control. The study included 156 patients undergoing orthopedic and general surgery.
In orthopedic procedures, six clinical indicators were observed, including hemostasis within six minutes and 24-hour postoperative drainage. In general surgery (e.g., lumpectomy), five indicators were assessed, such as time to hemostasis and postoperative gas passage.
Results showed that both the experimental (Surgiclean®) and control groups achieved a 100% hemostasis rate, with no significant difference in safety or efficacy-confirming that Surgiclean® performs on par with established market leaders.
Why Choose Surgiclean® Over Flowable Hemostats (e.g., Surgi-Flo®, Flo-Gel®)?
Flowable hemostats like Flo-Gel® and Surgi-Flo® are gelatin-thrombin-based gels that provide broad coverage, but they come with several drawbacks:
Complex Handling: They require multiple steps before use, including mixing with sterile solution using syringes and connectors.
Animal-Derived Ingredients: Both gelatin and thrombin pose biocompatibility and immunogenicity risks. Thrombin, derived from human plasma, may still carry residual viral load despite processing.
Limited Water Absorption: Their gel state reduces further absorption capacity.
Poor Control After Application: Due to their fluid nature, these gels may spread unintentionally, potentially entering blood vessels or nearby tissues-raising the risk of embolism or other adverse events, which have been documented.
In comparison, Surgiclean® offers a non-animal-derived, biocompatible, and easy-to-use alternative that provides targeted and controlled application without the complications associated with flowable products.