None listed
Conditions
Brief summary
Endoscopic Sinus Surgery (ESS) has a crucial role in the management of chronic rhinosinusitis (CRS), however post-operative scaring and adhesion is a significant cause of surgical failure. Chitosan-Dextran Gel (Chitogel) has been shown to be an effective haemostatic nasal packing following ESS which reduces adhesion formation and stenosis of sinus ostia. It has also been shown to promote healing up to even 12 months following surgery, as demonstrated by reduced oedema, granulation and pus formation when compared to no packing. The purpose of this study is to evaluate the effect of Chitogel against the current standard of nasal packing being used; Hydrogel (PureRegen Gel Sinus), on post-operative wound healing and patient experience. We will compare the effect of Chitogel with hydrogel (PureRegen Gel Sinus) being used at our institution. Our hypothesis is that use of Chitogel will yield different endoscopic appearances of the sinuses at post operative 2-week, and 3-month follow up checks.
Interventions
Chitogel is a postoperative hydrogel nasal dressing that can be applied to sinuses after endoscopic sinus surgery. The hydrogel is made by combining Chitosan, Dextran and Glycerol. Chitogel has been shown to be an effective haemostatic nasal packing following endoscopic sinus surgery which reduces adhesion formation and stenosis of sinus ostia. It has also been shown to promote healing up to even 12 months following surgery, as demonstrated by reduced oedema, granulation and pus formation when compared to no packing. The Chitogel is applied endonasally once, by the operating ear, nose and throat surgeon, at the end of surgery upon completion of the procedure. The gel comes in two components which are combined according to producer instruction manual. The gel is applied to the sinus cavity using a syringe and malleable cannula. 5-10mL will be applied, the same as the amount of Hydrogel (comparator) used. Endoscopic sinus surgery on average will take approximately 2 hours. Theatre staff will monitor that the application protocol is followed.
Sponsors
Study design
Eligibility
Inclusion criteria
Patients undergoing bilateral Functional ESS for CRS
Exclusion criteria
Allergy to shellfish Pregnancy/breast feeding Previous sinus surgery