What is PerClot?
PerClot is a medical device consisting of absorbable polysaccharide granules made from purified plant starch. It serves as an adjunctive hemostatic agent to manage bleeding during surgery. Manufactured by Baxter International Inc., it is applied as a dry, sterile powder using an applicator system. The granules are biocompatible, non-pyrogenic, and free of human or animal components.
How PerClot Works to Control Bleeding
PerClot's mechanism relies on its ability to quickly absorb water from blood. This process concentrates clotting factors, platelets, and red blood cells, accelerating the body's natural clotting cascade. The granules swell, forming a gelled, adhesive matrix that acts as a mechanical barrier.
The body's enzymes degrade the granules, leading to absorption within about 96 hours, depending on usage and site. Its absorbable nature eliminates the need for removal.
Indications and Delivery
PerClot is indicated for various surgical procedures, such as cardiac, general, and urological surgeries, to manage capillary, venous, and small arteriolar bleeding. It is not recommended for neurological or ophthalmic procedures.
- Open Surgical Procedures: Applied using a standard applicator tip.
- Laparoscopic Procedures: Uses specialized 38cm laparoscopic tips.
Application process:
- Remove excess blood by blotting or suctioning.
- Apply dry powder to the bleeding area using a bellows applicator.
- Apply pressure with a non-adhering material until hemostasis.
- Irrigate and aspirate to remove any excess dry powder.
Safety, Warnings, and Adverse Events
PerClot is generally safe and effective, but requires adherence to warnings and precautions.
Contraindications and Warnings
- Intravascular Injection: Strictly prohibited due to risk of life-threatening embolism.
- Severe Bleeding: Not for treating severe arterial bleeding; use conventional methods.
- Surgical Site: Use cautiously in contaminated areas.
- Patient Sensitivity: Not studied in patients sensitive to starch.
- Diabetic Patients: Limit use to 50g due to potential glucose load effects.
Potential Adverse Effects
Based on studies, potential issues include:
- Increased inflammatory markers and fever.
- Rare cases of infection and bowel obstruction, especially if residual powder is left.
- Compression due to swelling if excess powder is not removed from confined areas.
Comparison with Other Hemostatic Agents
| Feature | PerClot | Surgicel™ | Fibrin Sealants | Absorbable Gelatin Sponge |
|---|---|---|---|---|
| Composition | Polysaccharide granules (plant-based) | Oxidized Regenerated Cellulose (ORC) | Human or animal fibrinogen and thrombin | Purified porcine or bovine gelatin |
| Mechanism | Rapidly absorbs water to concentrate clotting factors and forms a physical gel matrix | Swells and converts to a gel to initiate clotting by forming a matrix | Combines fibrinogen and thrombin to form a natural fibrin clot | Provides a physical matrix for platelets and clotting factors to adhere to |
| Preparation | Ready to use, no mixing required | Ready to use, applied dry | Often requires mixing and application via specialized systems | Applied as a sponge, often with thrombin or saline |
| Efficacy | Effective for mild to moderate bleeding; comparable to similar polysaccharide agents | Highly effective; penetrates blood to reach bleeding source | Very effective, especially for severe bleeding and large surfaces | Effective, but may not be suitable for severe bleeding |
| Absorption | Absorbed within ~96 hours | Absorbed over weeks | Absorbed over weeks | Absorbed over weeks |
| Potential Risks | Rare infection if not removed, swelling risk in confined spaces, contraindicated for intravascular use | Possible nerve entrapment or foreign body reactions | Risk of thrombosis if absorbed systemically; potential for transmitting infectious agents | Foreign body reactions, potential for nerve damage with misuse |
| Handling | Delivered as a powder via bellows and applicator tips | Available as powder, knitted sheets, or fabrics | Comes in specialized applicators, often a liquid or gel | Sponge that can be cut to size |
The Role of PerClot in Surgical Hemostasis
PerClot is important in surgical practice as a reliable, ready-to-use option for bleeding control. Its plant-based formulation is beneficial for patients with sensitivities. Studies, like the CLOT trial, show comparable safety and efficacy to alternatives for intraoperative bleeding in general, cardiac, and urological surgeries. Using hemostatic agents like PerClot can support blood management strategies, potentially reducing transfusions and complications.
Conclusion
PerClot is an effective, absorbable hemostatic powder from plant starch for managing mild to moderate surgical bleeding. Its mechanism, involving rapid water absorption and gel matrix formation, enhances natural clotting. Applied via a simple system, PerClot is a user-friendly solution for various procedures. Surgeons must follow warnings, especially regarding intravascular use and removing excess powder. The integration of such products reflects medical technology advancements aimed at improving patient care. For FDA approval details, refer to the official document.
Sources
: https://www.accessdata.fda.gov/cdrh_docs/pdf21/P210036C.pdf
