FAQ

Haemostats

What is Oxidized cellulose and how do Traumastem absorbable haemostats work?

Oxidized cellulose is a natural material obtained by oxidizing high‑quality, long‑fiber cotton. When it comes into contact with blood, it rapidly forms a sticky gel that supports blood clot formation, promotes platelet adhesion, and aids in the local control of capillary, venous, and minor arterial bleeding. Absorbable hemostats Traumastem based on oxidized cellulose are safely resorbed by the body within several days.

What is the difference between Oxidized Cellulose (OC) and Oxidized Regenerated Cellulose (ORC)?

The key difference between Oxidized Cellulose (OC, sometimes referred to in scientific literature as ONRC – Oxidized Non‑Regenerated Cellulose) and Oxidized Regenerated Cellulose (ORC) lies in their origin and manufacturing process. OC—used, for example, in the Traumastem product line—is produced directly from natural fibers, typically high‑quality cotton, whereas ORC is derived from cellulose that undergoes chemical processing and regeneration before oxidation. Although the two materials come from different sources, they operate on the same haemostatic principle, and OC provides comparable efficacy without relying on chemically modified input material.

Do Traumastem haemostats have antimicrobial properties?

Yes. Traumastem hemostats exhibit natural antimicrobial activity due to the low pH of oxidized cellulose. This activity has been demonstrated in vitro against a broad range of microorganisms, including Gram‑positive and Gram‑negative bacteria, anaerobes, yeasts, molds, and also antibiotic‑resistant bacterial strains such as MRSA, MRSE and VRE. It is important to note that Traumastem acts only locally and does not replace systemic antibiotic therapy.

In which surgical specialties can Traumastem haemostats be used?

Traumastem haemostats are suitable for a wide range of surgical specialties where rapid and reliable local bleeding control is needed. They are used in general and abdominal surgery, trauma surgery, vascular surgery, gynecology, urology, ENT, thoracic and cardiac surgery, neurosurgery, plastic and reconstructive surgery, as well as oral and maxillofacial surgery. They can be applied in open, minimally invasive, and endoscopic procedures wherever standard mechanical hemostasis is insufficient or difficult to perform.

How should Traumastem haemostats be applied?

Traumastem hemostats are applied directly to the bleeding site — ideally on a dry and properly prepared wound surface — and gently pressed to ensure good tissue contact. For effective local bleeding control, only the minimum necessary amount of hemostat should be used.

Can Traumastem haemostats be left in the wound?

Traumastem hemostats are fully absorbable, and when used correctly, they gradually resorb from the application site. However, leaving them in the wound is not always recommended. After bleeding has been controlled, it is generally advisable to remove the hemostat, provided this is feasible.

If a clinician determines that leaving a small amount of the hemostatic material in place is beneficial for the specific procedure, it is acceptable.

The product is biodegradable and will be naturally absorbed. It should not be left in contaminated or non‑bleeding, exudating areas, where body fluids other than blood may slow its effect and biodegradation.

More guidance on safe use can be found in the product’s instructions for use.

Do Traumastem haemostats replace standard surgical techniques?

No. Traumastem hemostats are adjuncts for controlling capillary, venous, and minor arterial bleeding. They do not replace standard surgical methods such as suturing, ligatures, or cautery, which are required for more significant bleeding. The product is not a substitute for meticulous surgical technique.

Radiation services

Which material is suitable for wrapping the goods to be sterilized?

The wrapping material must be declared by its producer as suitable for radiation sterilization. If you are not sure, we can provide a test on material stability after the sterilization.

Is it possible to use the goods immediately after the irradiation?

Yes, it is possible. Radiation sterilization does not cause any secondary radioactivity or other harmful changes.

What is the overdose ratio?

The overdose ratio is 1,19 to 1,26, depending on density of irradiated material. Bioster irradiates the goods in blocks with dimensions 45 x45 x90 cm. Our overdose ratio is hence much less than with sterilization on pallets.

How long do goods keep sterile after sterilization?

As long as the package is kept microbially intact. The goods inside are sterile and cannot become non-sterile without microbes penetrating from the outside.

What is the sterilization dose?

The standard sterilization dose is a minimum of 25 kGy. It is a so called minimal sterilization dose. For testing purposes, we can administer any dose.

Is it possible to re-sterilize expired goods?

No, it is not. The goods and package are designed for only one sterilizing dose. Another irradiation decreases the durability of the package or the product or both.