Chitogel’s development is scientifically supported by 18+ published studies and scientific papers, proven claims of improved wound healing, reductions in ostial stenosis and minimising adhesions.
Chitogel has also been shown to promote a healthy sinus microbiome and reduce the rate of revision surgery.9 9Megow, A, Alsuliman Y, Bouras G, et al. Chitogel following endoscopic sinus surgery promotes a healthy microbiome and reduces postoperative infections. Int Forum Allergy Rhinol. 2022;1-15.16 16Barber JM, Bouras G, Robinson GS and Robinson SR. Chitogel improves long-term health economic outcomes following endoscopic sinus surgery in severe chronic rhinosinusitis patients. Front. Health Serv. 2024; 4:1196499. doi: 10.3389/frhs.2024.1196499.
Clinical results show that where Chitogel has been used post-operatively compared to no packing materials at 12 months post surgery, patients on average experience the following:1 1Ha T, Valentine R, Moratti S, Hanton L, Robinson S, Wormald P-J. 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.
Chitogel has been shown to reduce the rate of revision surgery, leading to health system efficiencies and cost savings. It has been shown that improvements to patient welfare and long-term cost savings significantly outweigh the initial cost of Chitogel.
A retrospective observational study demonstrated a significant reduction in revision surgeries conducted
during the 2-year patient follow up period among patients who underwent full endoscopic sinus surgery (FESS)
with Chitogel vs. those who underwent FESS with no packing material.16 16Barber JM, Bouras G, Robinson GS and Robinson SR. Chitogel improves long-term health economic outcomes following endoscopic sinus surgery in severe chronic rhinosinusitis patients. Front. Health Serv. 2024; 4:1196499. doi:10.3389/frhs.2024.1196499.
Assuming a cohort of 100 patients, the use of Chitogel over 2 years can result in:16 16Barber JM, Bouras G, Robinson GS and Robinson SR. Chitogel improves long-term health economic outcomes following endoscopic sinus surgery in severe chronic rhinosinusitis patients. Front. Health Serv. 2024; 4:1196499. doi: 10.3389/frhs.2024.1196499.
The importance of the microbiome in the sinonasal mucosal environment has been increasingly recognized. The process of performing sinus surgery creates a barren environment, knocking out important commensals that form the microbiome, which is linked with poor outcomes and the need for revision surgery.9 9Megow, A, Alsuliman Y, Bouras G, et al. Chitogel following endoscopic sinus surgery promotes a healthy microbiome and reduces postoperative infections. Int Forum Allergy Rhinol. 2022;1-15.
Recent clinical data shows that Chitogel significantly increases the abundance of commensal bacteria Corynebacterium accolens and Cutibacterium acnes forming the microbiome, resulting in a healthier sinus environment.9 9Megow, A, Alsuliman Y, Bouras G, et al. Chitogel following endoscopic sinus surgery promotes a healthy microbiome and reduces postoperative infections. Int Forum Allergy Rhinol. 2022;1-15.
Long lasting mucosal health
Megow et al propose a healthy sinonasal microbiome to “be composed of an increase in abundance of commensal microbiota and a decrease in pathogenic microbiota”.9 9Megow, A, Alsuliman Y, Bouras G, et al. Chitogel following endoscopic sinus surgery promotes a healthy microbiome and reduces postoperative infections. Int Forum Allergy Rhinol. 2022;1-15. Glycerol is a unique component of Chitogel that promotes the growth of commensal bacteria Cutibacterium acnes, which inhibit the growth of pathogenic bacteria.9 9Megow, A, Alsuliman Y, Bouras G, et al. Chitogel following endoscopic sinus surgery promotes a healthy microbiome and reduces postoperative infections. Int Forum Allergy Rhinol. 2022;1-15.
The sinus-microbiome is known to influence long-term sinus health and the need for revision surgery.16 16Barber JM, Bouras G, Robinson GS and Robinson SR. Chitogel improves long-term health economic outcomes following endoscopic sinus surgery in severe chronic rhinosinusitis patients. Front. Health Serv. 2024; 4:1196499. doi: 10.3389/frhs.2024.1196499. Chitogel has also been shown to reduce the rate of revision surgery, suggesting that the use of Chitogel can improve long-term patient outcomes.16 16Barber JM, Bouras G, Robinson GS and Robinson SR. Chitogel improves long-term health economic outcomes following endoscopic sinus surgery in severe chronic rhinosinusitis patients. Front. Health Serv. 2024; 4:1196499. doi: 10.3389/frhs.2024.1196499.
Chitogel enhances wound healing and has been shown to promote healthy sinuses9 9Megow A, Alsuliman Y, Bourgas G, et al. Chitogel following endoscopic sinus surgery promotes a healthy microbiome and reduces postoperative infections. Int Forum Allergy Rhinol. 2022;1-15., control minimal bleeding after sinus surgery11 11FDA 510K, Chitogel Endoscopic Sinus Surgery Kit, K172179.510K, Summary.Final and prevent adhesions between mucosal surfaces in the nasal cavity.1 1Ha T, Valentine R, Moratti S, Hanton L, Robinson S, Wormald P-J. 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.
Chitogel addresses a number of traditional sinus surgery shortcomings, and is clinically proven to reduce ostial stenosis, minimise adhesions and act as an adjunct in the natural healing process1 1Ha T, Valentine R, Moratti S, Hanton L, Robinson S, Wormald P-J. The efficacy of a novel budesonide chitosan gel on wound healing following endoscopic sinus surgery. Int Forum Allergy Rhinol. 2018 Mar;8(3):435-443.2 2Athanasiadis T, Beule AG, Robinson BH, Robinson SR, Shi Z, Wormald PJ. Effects of a novel chitosan gel on mucosal wound healing following endoscopic sinus surgery in a sheep model of chronic rhinosinusitis. Larygoscope. 2008 Jun;118(6):1088-94.
The frontal sinus has the highest rate of stenosis, with rates reported of up to 60%.13 13Friedman M, Landsberg R, Schults RA, Tanyeri H, Caldaerlli DD. Frontal sinus surgery: endoscopic technique and preliminary results. Am J Rhinology. 200;14(6):393-403.
Chitogel at post 12 months-operation is on average nearly twice as effective for maintenance of the original frontal ostial size, compared to using no packing materials.1 1Ha T, Valentine R, Moratti S, Hanton L, Robinson S, Wormald P-J. 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.
In this study, the average control frontal ostium shrunk to 37% of the original size while the average Chitogel frontal ostium was 64% of the original size, almost double the size of the control ostium.
Chitogel at 12 months post operation is on average 35% better at maintaining the original sphenoid sinus ostial size compared to using no packing materials.1 1Ha T, Valentine R, Moratti S, Hanton L, Robinson S, Wormald P-J. 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.
In this study at 12 months post-operation the average control sphenoid ostium shrunk to 52% of the original size, while the average Chitogel sphenoid ostium was 70% of the original size.
Chitogel at 12 months post operation is on average 34% better at maintaining the original maxillary sinus ostial size compared to using no packing materials.1 1Ha T, Valentine R, Moratti S, Hanton L, Robinson S, Wormald P-J. 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.
In this study at 12 months post-operation, the average control maxillary ostium shrunk to 58% of the original size, while the average Chitogel maxillary ostium was on average 78% of the original size.
Traditional removable nasal packing is rated by patients as the most unpleasant and painful aspect of the FESS experience15 15Chandra RK, Kern RC. Advantages and disadvantages of topical packing in endoscopic sinus surgery. Current opinions and Otolaryngology Head Neck Surgery. 2004;12(1):21-26, and is associated with significant mucosal trauma.14 14Shaw 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. Additionally, novel absorbable nasal packing agents have been developed in recent years, but have not shown a significant decrease in adhesion formation.3 3Chandra 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.
Chitogel at 12 months post-operation results in an average of 47% reduction in incidence of adhesions compared to using no packing materials. In this study at 12 months post operation, the control side had an average incidence of adhesion of 15%, while the Chitogel side had an average incidence of adhesion of only 8%.1 1Ha T, Valentine R, Moratti S, Hanton L, Robinson S, Wormald P-J. 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
Chitogel is also soft, pliable and easily applied, optimising patient comfort.
The effectiveness of the natural healing process post endoscopic sinus surgery can be indicated by a number of factors including the level of oedema, granulation, pus and crust formation.
Chitogel at 12 months post-operation reduced the incidence of oedema, granulation, pus and crust formation by 50% when compared to using no packing materials.1 1Ha T, Valentine R, Moratti S, Hanton L, Robinson S, Wormald P-J. 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.