What is Surgiclean® ORC Absorbable Gauze?
Surgiclean® is medical gauze used to stop bleeding during surgeries. The raw material is regenerated cellulose made from special fiber through oxidation and trimming. This smart hemostatic material can be decomposed and absorbed during the healing process of human wound tissue without residual material.
Expected Time of CE Marking: April 2020
Principle of action:
Surgiclean® Gauze is highly carboxylated, can absorb erythrocytes, adhere to platelets and activate the clotting systems, thereby promoting hemostasis. After the Gauze has been saturated with blood, it swells into a brownish or black gelatinous mass which aids in the formation of a clot, thereby serving as a hemostatic adjunct in the control of local haemorrhage. Usually the bleeding is stopped within minutes.
The Gauze degradation in vivo begins after hemostasis, and its absorption rate depends on multi factors, including the dose used, the site being treated, and the degree of blood permeation.
As a supporting hemostatic device, this product is suitable for various surgical procedures. It can help control the bleeding of capillaries, veins and small arteries where bleeding can’t be well controlled by traditional methods like binding or suturing.
Methods of application:
Check the integrity of sterile container, do not use if the package is broken.
Remove the Gauze from the aluminum-plastic bag, cut out a suitable and minimal size, place the cutted Gauze on the hemostatic site and press firmly until bleeding stops. The quantity is determined according to the bleeding site and the amount of bleeding.
Size can be customized.
1. Sterile, for single use, recycle not permitted.
2. Do not use if the package is broken.
3. This product is a supporting material to conventional haemostasis methods; it cannot replace suture and ligature, etc.
4. Applying the Gauze in a contaminated wound without drainage may lead to complications. It should be avoided.
5. This product has excellent water absorption, keep away from liquids before using.
6. This product has a low pH; do not mix/use with enzyme based hemostatic agents.
7. Do not remove the Gauze before bleeding completely stops.
8. Remove any excess after haemostasis is achieved in order to minimize the possibility of foreign body reaction.
9. Since absorption of the product could be prevented in chemically cauterized areas, its use should not be preceded by application of silver nitrate or any other escharotic chemicals.
10. Precautions should be taken in otorhinolaryngologic surgery to assure that none of the material is aspirated by the patient.
11. Use of this product near large and medium blood vessels may result in vascular embolism.
12. This product can promote blood coagulation at the site of use. Excessive use of this product may cause thrombosis at the site of use.
13. This product must not be used in conjunction with a blood recovery system, as product fragments may pass through the filter causing blockages in the blood recovery system or the patient’s vasculature.
14. The product must not be used in conjunction with a methyl methacrylate adhesive for prosthetic orthopedic devices, which may reduce the strength of the adhesive.