A Single-Blinded Randomised Trial Evaluation of the Efficacy of Purastat versus Chitogel on Post-Operative Outcomes in the Treatment of CRS
Dr Michael Lee, ENT Registrar, Albury Wodonga Health Service, Sydney, Australia
Authors List
Michael Fook-Ho Lee, Marina Cavada, Yuresh Naidoo
Introduction: Chronic rhinosinusitis (CRS) affects approximately 15% of the population and is characterised by sinusitis symptoms persisting for more than 3 months. Patients adequately to maximal medical treatment require functional endoscopic sinus surgery (FESS) to open obstructed sinuses. Stenosis of sinus openings is the primary cause of failure of this operation. Nasal dressings are commonly used to prevent ongoing bleeding, adhesions and augment wound healing. Chitogel and PuraStat are two products already seeing use as a dressing following sinus surgery in Australia. Chitogel has been shown in a 2022 Phase 1 clinical trial to improve patient-reported symptom scores but had no effect on maintaining post-operative ostium patency and mucosal healing compared to no dressing. PuraStat has been shown in a 2023 animal study to improve haemostasis, mucosal healing and reduce adhesions compared to no dressing.
Aim: We aim to compare the performance of PuraStat with our current standard of care, Chitogel on post-operative adhesion formation, ostium patency, haemostasis, infection and patient-reported symptoms scores.
Methods: 40 patients with chronic rhinosinusitis undergoing bilateral full-house FESS were recruited between February and June 2025. Each was randomised to receive either PuraStat or Chitogel dressings to opposite sides of the nose. Sinus ostia size were measured intra-operatively, and at 2, 6 and 12 weeks post-operatively by two blinded investigators. Presence and severity of adhesions, mucopurulent discharge, mucosal oedema, crusting, granulation and patient-reported symptom score questionnaires were also recorded at every post-operative follow-up.
Michael Fook-Ho Lee, Marina Cavada, Yuresh Naidoo
Introduction: Chronic rhinosinusitis (CRS) affects approximately 15% of the population and is characterised by sinusitis symptoms persisting for more than 3 months. Patients adequately to maximal medical treatment require functional endoscopic sinus surgery (FESS) to open obstructed sinuses. Stenosis of sinus openings is the primary cause of failure of this operation. Nasal dressings are commonly used to prevent ongoing bleeding, adhesions and augment wound healing. Chitogel and PuraStat are two products already seeing use as a dressing following sinus surgery in Australia. Chitogel has been shown in a 2022 Phase 1 clinical trial to improve patient-reported symptom scores but had no effect on maintaining post-operative ostium patency and mucosal healing compared to no dressing. PuraStat has been shown in a 2023 animal study to improve haemostasis, mucosal healing and reduce adhesions compared to no dressing.
Aim: We aim to compare the performance of PuraStat with our current standard of care, Chitogel on post-operative adhesion formation, ostium patency, haemostasis, infection and patient-reported symptoms scores.
Methods: 40 patients with chronic rhinosinusitis undergoing bilateral full-house FESS were recruited between February and June 2025. Each was randomised to receive either PuraStat or Chitogel dressings to opposite sides of the nose. Sinus ostia size were measured intra-operatively, and at 2, 6 and 12 weeks post-operatively by two blinded investigators. Presence and severity of adhesions, mucopurulent discharge, mucosal oedema, crusting, granulation and patient-reported symptom score questionnaires were also recorded at every post-operative follow-up.
