Chronic Sinusitis

26 million Americans suffer from sinusitis, living with inflammation or swelling of the sinuses and nasal cavity.1 1Summary Health Statistics for U.S. Adults: National Health Interview Survey, 2012. Patients with chronic sinusitis often suffer from a range of symptoms which significantly reduce their enjoyment of life.2 2Citation content here

Many patients with chronic sinusitis whose conditions fail to respond to medical treatment require surgery to return their sinus cavities to normal. Chitogel is a  surgical gel designed to  improve surgical outcomes in the treatment of sinusitis.

What is Chronic Sinusitis?

Sinusitis is inflammation or swelling of the tissues lining the sinuses and nasal cavity. Infections of viruses, bacteria, fungus or allergies cause the majority of cases. Patients with chronic sinusitis often suffer from a range of symptoms which impact on their enjoyment of life, including: 2 2Yan M, Zheng D, Li Y, et al. Biodegradable nasal packings for endoscopic sinonasai surgery: A systematic review and meta-analy­sis. PloS One 9:e115458, 2014..

  • nasal congestion or blockage
  • headaches, facial pain;
  • sinus pressure;
  • nasal discharge;
  • loss of smell and/or taste; and
  • sleep deprivation and fatigue.

Functional endoscopic sinus surgery (FESS) is the surgical treatment of choice for chronic sinusitis.6 6Lazar RH, Younis RT, and Long TE. Functional endonasal sinus surgery in adults and children. Laryngoscope 103(pt. 1):1-5, 1993.

How Endoscopic Sinus Surgery Treats Chronic Sinusitis

The aim of FESS is to eliminate the factors contributing to sinus inflammation and restore ventilation and drainage of the paranasal sinuses.

FESS involves the precise removal of diseased sinus tissue with improvement in the natural drainage channels by the creation of a pathway for infected material to drain from the sinus cavities. FESS may also involve the removal of nasal polyps which are an overgrowth of tissue within the sinuses that block the flow of mucus and air.

In most situations, the surgery is performed as an outpatient at a hospital or a surgical center. Post-operative care is critical for recovery, with nasal irrigation required.

Critical to the success of FESS is the ability of the sinuses, that have been opened surgically, to maintain their patency long term.

Traditional Sinus Surgery Shortcomings


Sinus surgery is often less successful than desired with problems arising when openings narrow or close off (stenosis) due to scar tissue forming:

  • Scarring and adhesion formation is one of the main causes of surgical failure, estimated to occur in between 10 to 30% of patients.10 10Wormald PJ. Endoscopic Sinus Surgery – Anatomy, Three-Dimensional Reconstruction, and Surgical Technique. New York: Thieme; 2005.
  • The incidence of ostial stenosis following ESS has been estimated to be approximately 25%.8 8Ramadan HH. Surgical causes of failure in endoscopic sinus surgery. Laryngoscope. 1999;109(1):27-29.
  • The frontal sinus has the highest rate of stenosis, with rates reported of up to 60%.9 9Jacobs JB. 100 years of frontal sinus surgery. Laryngoscope. 1997;107(11 Pt 2):1-36.
  • The frontal sinus is particularly prone to stenosis due to its narrow size, close adjacent surrounding structures such as the skull base and orbit, and residual bony septations after surgery.28 28Friedman M, Landsberg R, Schults RA, Tanyeri H, Caldarelli DD. Frontal sinus surgery: endoscopic technique and preliminary results. Am J Rhinology. 2000;14(6):393-403.

Removable nasal packing has been the traditional method of preventing adhesion formation following FESS. However it is rated by patients as the most unpleasant and painful aspect of the FESS experience5 5Chandra RK, Kern RC. Advantages and disadvantages of topical packing in endoscopic sinus surgery. Current Opinions in Otolaryngology Head Neck Surgery. 2004;12(1):21-26., and is associated with significant mucosal trauma as the packing is removed.6 6Shaw CL, Dymock RB, Cowin A, Wormald P-J. Effect of packing on the nasal mucosa of sheep. Journal of Laryngology and Otology. 2000;114:506-509.

Novel absorbable nasal packing agents have been developed in recent years but have not shown a significant decrease in adhesion formation.17 17Chandra RK, Conley DB, Haines GK, 3rd, Kern RC. Long-term effects of FloSeal packing after endoscopic sinus surgery. American journal of rhinology. 2005;19(3):240-243.

If FESS is unsuccessful then a recurrence of the symptoms of sinus disease will often follow. Subsequently additional medical treatment and revision surgical procedures are often required.

Chitogel’s unique characteristics improve outcomes


Chitogel is a  postoperative hydrogel nasal dressing that can be applied to sinuses after endoscopic sinus surgery and addresses a number of the traditional sinus surgery shortcomings:

  • Reduces frontal, sphenoid & maxillary ostial stenosis following endoscopic sinus surgery
  • Reduces adhesion formation
  • A soft, pliable and easily applied dressing that is supportive and stenting, significantly improving patient comfort
  • A Haemostatic agent, controls minimal bleeding following surgery by the tamponade effect, blood absorption and platelet aggregation
  • Clears naturally post surgery with nasal irrigation

  • A proven adjunct to aid in the natural wound healing process
    • Reduces granulation tissue formation
    • Reduces edema
    •  pus formation
    • Reduces formation

Chitogel is improving surgery outcomes and patients’ lives

Clinically Proven Results

Chitogel is clinically proven to reduce ostial stenosis, minimize adhesions and act as an adjunct to aid in the natural healing process.

Clinical results show that where Chitogel has been used post surgery compared to using no packing materials at 12 months post surgery, patients on average experienced the following: 13 13Ha T, Valentine R, Moratti S, Hanton L, Robinson S, Wormald PJ. The efficacy of a novel budesonide chitosan gel on wound healing following endoscopic sinus surgery. Int Forum Allergy Rhinol. 2018 Mar;8(3):435-443.

73%

Improvement in frontal ostial area

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35%

Improvement in sphenoid ostial area

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34%

Improvement in maxillary ostial area

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47%

Reduction in incidence of adhesion

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50%

Reduction in incidence of edema

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50%

Reduction in incidence of granulation

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