Chronic Sinusitis

30 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 2Tomblinson CM, Cheng MR, Lal D, and Hoxworth JM. The impact of middle turbinate concha bullosa on the severity of inferior turbinate hypertrophy in patients with a deviated nasal septum. AJNR Am J Neuroradiol 37:1324-1330, 2016.,3 3Barakate M, and Havas T. Surgical management of paediatric chronic rhinosinusitis: Review of 10 years’ experience. J Laryngol Oto! 128(suppl. 2):S43-S47, 2014.

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 highly effective surgical gel designed to significantly 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: 4 4Yan 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.,5 5Hobson CE, Choby GW, Wang EW, et al. Systematic review and metaanalysis of middle meatal packing aiter endoscopic sinus sur­gery. Am J Rhino! Allergy 29:135-140, 2015.

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

Endoscopic sinus surgery (ESS) 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.,7 7Kaliner MA, Osguthorpe JD, Fireman P, et al. Sinusitis: bench to bedside. Current findings, future directions. Otolaryngology Head Neck Surg. 1997;116(6 Pt 2):S1-20.,8 8Steele TO, Detwiller KY, Mace JC, et al. Productivity outcomes following endoscopic sinus surgery for recurrent acute rhinosinusitis. Laryngoscope 126:1046-1053, 2016.

How Endoscopic Sinus Surgery Treats Chronic Sinusitis

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

ESS 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. ESS 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 ESS 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:

  • Ongoing bleeding and adhesion formation remain the two most common complications following surgery.9 9Gross RD, Sheridan MF, Burgess LP. Endoscopic sinus surgery complications in residency. The Laryngoscope. 1997;107(8):1080-1085.
  • 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%.11 11Ramadan 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%.12 12Jacobs JB. 100 years of frontal sinus surgery. Laryngoscope. 1997;107(11 Pt 2):1-36.,13 13Hosemann W, Kuhnel T, Held P, Wagner W, Felderhoff A. Endonasal frontal sinusotomy in surgical management of chronic sinusitis: a critical evaluation. Am J Rhinology. 1997;11(1):1-9.
  • 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.14 14Friedman M, Landsberg R, Schults RA, Tanyeri H, Caldarelli DD. Frontal sinus surgery: endoscopic technique and preliminary results. Am J Rhinology. 2000;14(6):393-403.15 15Hunter B, Silva S, Youngs R, Saeed A, Varadarajan V. Long-term stenting for chronic frontal sinus disease: case series and literature review. Journal of Laryngology and Otology. 2010;124(11):1216-1222.16 16Casiano RR, Livingston JA. Endoscopic Lothrop procedure: the University of Miami experience. Am J Rhinology. 1998;12(5):335-339.17 17Becker DG, Moore D, Lindsey WH, Gross WE, Gross CW. Modified transnasal endoscopic Lothrop procedure: further considerations. Laryngoscope. 1995;105(11):1161-1166.

Removable nasal packing has been the traditional method of preventing adhesion formation following ESS. However it is rated by patients as the most unpleasant and painful aspect of the ESS experience18 18Chandra 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.19 19Shaw 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.20 20Chandra 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.,21 21Maccabee MS, Trune DR, Hwang PH. Effects of topically applied biomaterials on paranasal sinus mucosal healing. Am J Rhinology. 2003;17(4):203-207.

If ESS 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 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:

  • Significantly reduces frontal, sphenoid & maxillary ostial stenosis following endoscopic sinus surgery
  • Highly effective at reducing adhesion formation
  • A soft, pliable and easily applied dressing that is supportive and stenting, significantly improving patient comfort
  • Highly effective 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
    • Highly effective at reducing granulation tissue formation
    • Highly effective at reducing edema
    • Highly effective at reducing pus formation
    • Highly effective at reducing crust formation

Chitogel is improving surgery outcomes and patients’ lives

Clinically Proven Results

Chitogel is clinically proven to significantly reduce ostial stenosis, reduce 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: 24 24Ha 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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