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Safety Information

Safety Information

The Chitogel Endoscopic Sinus Surgery Kit (“Chitogel”) is a highly effective postoperative hydrogel nasal dressing that can be applied to sinuses after endoscopic sinus surgery and addresses a number of the traditional sinus surgery shortcomings.

  1. Chitogel significantly reduces frontal, sphenoid and maxillary ostial stenosis following endoscopic sinus surgery.
  2. Chitogel is highly effective at reducing adhesion formation.
  3. Chitogel is a proven adjunct to aid in the natural wound healing process, reducing granulation tissue formation, edema, pus formation and crust formation.
  4. Chitogel is a soft, pliable and easily applied dressing that is supportive and stenting, significantly improving patient comfort.
  5. Chitogel is a highly effective haemostatic agent, which controls minimal bleeding following surgery by the tamponade effect, blood absorption and platelet aggregation.
  6. Chitogel clears naturally post surgery with nasal irrigation.
  7. Chitogel is indicated for use in patients undergoing nasal/sinus surgery as a space occupying packing.
  8. Chitogel contains chitosan from shellfish and should not be used in patients with known allergic responses to shellfish. Physicians should test for shellfish allergic response if status unknown, prior to use.
  9. Chitogel should not be used in surgery involving any of the following complications: any form of cerebrospinal fluid leak; or any form of ophthalmic complication, including but not limited to orbital hemorrhage or haematoma and exposure of the orbital tissues.
  10. In rare instances, the physiochemical condition associated with Functional Endoscopic Sinus Surgery, both with and without material application, may present a risk of toxic shock syndrome (TSS). Warning signs of TSS include: sudden fever (usually 39°C), vomiting diarrhea, dizziness, fainting (or near fainting when standing up), and/or a rash that looks like a sunburn.
  11. Foreign body reaction may occur as with most surgical adjuvant treatments.
  12. Chitogel must be used according to the Instructions for Use.
  13. Chitogel Limited may update this Safety Information at any time and will notify you of any changes by amending the “last updated” notice at the bottom of this page.

Last updated 5 July 2018