Hemostatic Fiber Gauze
Surgiclean® Fibril Absorbable Hemostat is used adjunctively in surgical procedures to assist in the control of capillary, venous, and small arterial
hemorrhage when ligation or other conventional methods of control are impractical or ineffective. lt can be cut to size for use in endoscopic procedures.
Mechanism
Advantage
4 invention patents
Rapid hemostasis with zero residue
Easily shaped to address each particular bleeding site
Three-dimensional structure to achieve effective hemostasis
Absorbable and degradable
In the human body, Surgiclean can be completely degraded into glucose by biological enzymes, and finally metabolized into CO2 and H2O by tissues. The general absorption time is 7-14 days.
Three-dimensional structure of Surgiclean, effective and rapid hemostasis.
Loose network porous structure which can improve water absorption, accelerate gelation rate and dissolution rate and ensure large contact area.
After contacting with blood, the single fiber swells obviously and Surgiclean® can absorb blood 20-30 times its own mass, just like S Product.
Fast hemostatic rate. In clinical trials, the effective rate of hemostasis within 1 minute of Surgiclean® is 98.6%.
Fully absorbed, zero residue
Surgiclean® is completely absorbed by the body with no residue. Absorption Time: 7-14 days. Basically absorbed in seven days, invisible to the naked eye
100% Plant origin and composed of oxidized regenerated cellulose
No risk of animal-derived allergy
No potential risk of pathogen transmission
Controllable selective oxidation system, more stable product quality
It can be layered and easy to be shaped for complex wounds
It can be separated into multiple layers to meet the needs of different wounds
It can be easily shaped to address each particular bleeding site and is suitable for various complex wounds
After absorbing water, the hemostatic effect can be observed through the thin layer
Adhere to the wound, but do not adhere to gloves and instruments, convenient for removing during operation
Method of Use
- According to the size and shape of the wound, the doctor can take appropriate size and layers of Surgiclean® to cover the wound.
Specification
|
2cm*3cm |
pc |
| 2.5*5cm | pc |
| 3cm*4cm | pc |
| 3cm*5cm | pc |
| 5cm*5cm | pc |
| 5cm*10cm | pc |
| 10cm*10cm | pc |
Process advantages
Certification
1.4 Invention Patents, 1 Utility Model Patent
2.Ensures Surgiclean® Superior Product Quality and A Competitive Edge
Clinical Data
▲ Hemostatic Effective Rate
Through the clinical trials of open surgery and laparoscopic surgery, the subjects were divided into the test group (Surgiclean) and the control group (S product). The test results showed that the test group (N=144) and the control group (N=144) have significant hemostatic effect, the hemostatic effective rate of the test group (N=144) and the control group (N=144) with 2 minutes are both 100%.
Clinical Trials
Clinical trials were carried out in 6 types of open surgery and 5 types of laparoscopic surgery.
Open surgery: thyroidectomy, lumpectomy, inguinal hernia repair, appendectomy, cholecystectomy, radical gastrectomy;
Laparoscopic surgery: laparoscopic cholecystectomy, laparoscopic thyroidectomy, laparoscopic inguinal hernia repair, laparoscopic appendectomy, laparoscopic liver and spleen surgery.
Safety Evaluation
B-ultrasound examination was performed between the two groups one month after
operation, and 138 subjects in the test group (Surgiclean®) and 136 subjects in the control
group (S Product) completed the follow-up visit. The absorption rate of the test group by
B-ultrasound examination was 96.4%, and that of the control group was 94.1%.
During the clinical trial period, there were no adverse events of foreign body reaction,
thrombosis, coagulation dysfunction, and local allergic reaction of both groups; 1 second
bleeding was observed in the control group.
Animal Testing: Safety (Pathological Observation)
Pathological observation on the liver, heart, lung, kidney, spleen and chest of minipigs in each group (hematoxylin-eosin staining)
- Compared with the sham operated group, no obvious pathological changes were found in the major organ tissues of the minipigs in the Test Group and the Control Group. The scale is 250μm.
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