Clinical evidence & documentation

Cellulose — a natural plant fiber. WoundClot® is the only non-oxidized, non-regenerated cellulose structure (NONRCS) product in the world. Other cellulose hemostats are manufactured by breaking the cellulose down through oxidization, which substantially reduces the product's ability to absorb blood, adhere to wound surfaces and create an environment conducive to hemostasis.

There is none. Because of its patented manufacturing process, the material itself is engineered to be inherently hemostatic. Other hemostats use a synthetic or natural substrate impregnated with an active ingredient such as kaolin, chitosan, collagen, silica or thrombin.

Mineral-based hemostats are a non-resorbable, non-woven fiber impregnated with an active ingredient such as kaolin — an inorganic fine white clay resulting from the natural decomposition of other clays or feldspar. They work through a single mechanism: activation of Factor XII (Hageman factor). They require intense manual pressure for at least three to five minutes to be effective.

WoundClot® uses multiple mechanisms — rapid fluid absorption, adherence and expansion in the wound, aggregation of platelets, red blood cells and clotting factors, and activation of Factors XI and XII — and remains actively absorbent in the wound for up to 24 hours.

Chitosan-based hemostats are a non-resorbable, non-woven fiber impregnated with chitosan — a sugar obtained from the hard outer skeleton of shellfish including crab, lobster and shrimp. They work through a single mechanism: attracting negatively charged red blood cells with a positively charged active ingredient.

WoundClot® uses multiple mechanisms and contains no shellfish-derived material.

ORC hemostats are based on technology more than seventy-five years old. They have a tendency to stick to gloved hands and instruments rather than to the intended wound surfaces. Some ORC products are FDA Class III surgical implantables, but their Instructions for Use indicate they should be removed wherever possible because of the increased risk of infection or adverse reaction. ORCs are not designed for use where persistent or heavy bleeding is occurring.

WoundClot® is the world's only NONRCS product. It is highly absorbent — up to 2,500% of its weight in fluid — highly adherent to wound surfaces even in high-pressure bleeding, and actively absorbent for up to 24 hours in the wound. It is specifically engineered to manage mild, moderate and severe bleeding.

Yes — it is one of the four mechanisms. WoundClot® is engineered with specific functional molecular groups that activate Factors XI and XII, converting them to XIa and XIIa.

No. In the United States WoundClot® is an FDA-cleared hemostat indicated for the effective control of mild, moderate and severe bleeding, as well as bleeding at operative, post-operative and donor sites. It is cleared to remain in a wound for up to 24 hours and must be removed prior to closure.

In the European Union and other territories, WoundClot® is a CE Class III surgical implantable device in sizes up to 4" × 4".

It is removed by lifting the clot. Re-bleeding will not occur, and any remaining gel can be irrigated out of the wound.

Yes. WoundClot® is effective in patients on antiplatelet or anticoagulant therapy — including warfarin, aspirin and heparin — and in patients presenting with coagulopathy. This follows from its multiple mechanisms of action rather than reliance on a single intact pathway.

Yes. The manufacturer reports favorable performance in epistaxis and in labial bleeding.

Five years.

No. Prolonged heavy adjunctive pressure is not required — hand weight or simple placement pressure is sufficient. This distinguishes it from mineral-based hemostats, which require intense manual pressure for three to five minutes.