Photo by Cresilon®
TRAUMAGEL® is a promising new hemostatic gel developed by Cresilon®, a Brooklyn-based biotechnology company. This innovative product has recently received FDA clearance and is designed to control moderate to severe bleeding quickly and effectively.
FDA clearance was granted through the 510(k) Premarket Notification process, which means that the device was found to be substantially equivalent to a legally marketed predicate device. This clearance allows TRAUMAGEL® to be marketed for its intended use in controlling moderate to severe bleeding.
Composition and Mechanism
TRAUMAGEL® is made from a blend of two long strands of sugar found in algae. This plant-based hydrogel is designed to create a mechanical plug that stops bleeding almost instantaneously when applied to a wound. Unlike traditional methods such as gauze or bandages, which can reopen wounds when removed, TRAUMAGEL® wipes away without disturbing the clot formed underneath.
Applications
TRAUMAGEL® is intended for use in a variety of settings, including military, emergency medical services (EMS), and civilian trauma care. Its ability to flow into wounds and reach injured areas makes it particularly effective for treating gunshot wounds and other traumatic injuries. The gel’s quick deployment and ease of application allow it to treat all surfaces of a wound, providing comprehensive bleeding control.
TRAUMAGEL® is currently cleared for use by licensed medical professionals in the US only. The gel is FDA cleared for external use to control moderate to severe bleeding. There is also strong potential for TRAUMAGEL® to be used in treating traumatic brain injuries in the future. Cresilon® plans to invest further in adding neuroprotection to the product, potentially expanding its applications to stabilize brain injuries.
Advantages
TRAUMAGEL® offers several advantages over traditional hemostatic agents:
- Rapid Bleeding Control: TRAUMAGEL® stops bleeding within seconds, providing immediate relief in critical situations.
- Ease of Use: The gel is supplied in a pre-filled syringe, making it easy to apply without any preparation.
- Comprehensive Coverage: TRAUMAGEL® flows into wounds, ensuring all surfaces are treated effectively.
- Minimal Disruption: Unlike gauze or bandages, TRAUMAGEL® can be wiped away without disturbing the clot formed underneath.
Uses
TRAUMAGEL® is designed to control moderate to severe bleeding and has been rigorously tested in preclinical models, demonstrating its effectiveness in achieving both initial and long-lasting hemostasis. This innovative hemostatic agent is particularly useful in managing severe bleeding scenarios.
TRAUMAGEL® is versatile and can be applied to various types of injuries, including non-compressible junctional injuries, extremity injuries, and situations where tourniquets cannot be used. It is effective for penetrating wounds such as gunshot wounds, stabbings, deep lacerations, scalp injuries, amputations, road rash, and large skin tears. Notably, TRAUMAGEL® is the only flowable hemostatic agent approved for use in moderate to severe bleeding cases.
TRAUMAGEL® should be removed within 24 hours of application. The removal process involves using saline lavage and gauze, ensuring that the clot remains undisturbed while the gel is cleared away.
Conclusion
TRAUMAGEL® represents a significant advancement in hemostatic technology, offering a quick, effective, and easy-to-use solution for controlling severe bleeding. Its FDA approval and potential future applications make it a valuable addition to the arsenal of medical professionals, first responders, and military personnel. As Cresilon® continues to develop and refine TRAUMAGEL®, its impact on emergency medical care is expected to grow, potentially saving countless lives.
Disclaimer
This article is not intended as medical advice or to replace appropriate training in the selection, safe use, and application of any hemostatic agent or medical device.
Source
Cresilon
cresilon.com