Hemostatic pad BIOPAPER®

neurosurgerycardiovascular surgeryorthopedic surgery

Datsing BioPaper is a paper-like, biodegradable polysaccharide membrane intended as an adjunctive surgical hemostatic material that stops blood oozing, prevents tissue adhesion and provides an adhesive sealing layer. It forms a transparent gel barrier that adheres to the wound surface and is resorbed by the body after application.


Safety

• Excellent biocompatibility; no cytotoxicity reported.
• No skin sensitization, no irritation, and no acute systemic toxicity observed.
• No risk of animal disease transmission or immunogenicity linked to the material.
• Neutral pH.

Key features

• Stop blood oozing – acts at physical, molecular and physiological levels to control oozing from surgical wounds.
• Anti-adhesion – forms a gel layer that acts as a physical barrier, reducing tissue adhesion and fluid leakage.
• Adhesive sealing – transparent gel layer seals wound surfaces effectively.
• Biodegradable – manufacturer reports 100% degradation to CO2 and H2O within 28 days; animal data indicate complete resorption within 12 weeks.

Application

• Applicable in neurosurgery, orthopedics, general, cardiac, thoracic, hepatobiliary and urology surgeries to reduce blood-oozing and tissue adhesion.
• In neurosurgery, can be applied for dura mater sealing to prevent cerebrospinal fluid leakage.

Intended user

• For use by trained physicians only.

Contraindications & limitations of use

• Do not use in patients with known hypersensitivity to any product ingredient.
• Patients with shellfish allergy should not use this product.
• Not indicated for control of hemorrhage from large arteries.
• Not intended for control of postpartum hemorrhage or menorrhagia.
• Maximum total usage per person: 360 cm² (equivalent to nine pieces of 5 cm × 8 cm).

Warnings

• Provided sterile and intended for single use only; do not resterilize or reuse (reprocessing may compromise integrity and increase infection risk).
• Use before the expiration date.
• Do not leave plastic backing or packaging materials inside the patient.
• Not a substitute for sound surgical technique, proper sutures or ligatures.
• Keep product dry prior to application; ensure surgical field is adequately cleared of excess fluids before placement.
• No hazards identified for use in MR environments; no MR image artifact effects reported.

Precautions

• BioPaper can be cut, folded or curled to fit wound geometry as needed.
• If repositioning is necessary, adjust placement within 20 seconds; thereafter the material becomes very adhesive and difficult to move.
• Foreign body reactions may occur with any implanted material.
• Handle with dry instruments or gloves; avoid tissue contact until at application site (important during endoscopic procedures).
• In case of re-bleeding, apply an additional piece directly to the bleeding site.

Technical specifications

• Denomination / form: paper-like membrane (BioPaper) made of polysaccharides.
• Function: adjunctive hemostatic material, anti-adhesion barrier, adhesive sealing layer.
• Degradation: manufacturer states 100% degrades to CO2 and H2O within 28 days; animal studies show complete degradation within 12 weeks.
• pH: neutral.
• Intended surgical areas: neurosurgery (including dura sealing), orthopedics, general surgery, cardiac, thoracic, hepatobiliary and urology.
• Maximum recommended amount per person: 360 cm² (≈ nine 5×8 cm pieces).
• Sterility / single use: supplied sterile; single-use only (do not resterilize or reuse).