Abstract
Background & Objectives
Ostial stenosis and persistent inflammation are the main reasons for revision endoscopic sinus surgery (ESS). Post-operative (PO) dressings can improve PO wound healing and patient outcomes after ESS. This study aimed to determine the safety and efficacy of Chitogel, with and without Deferiprone (Def) and Gallium Protoporphyrin (GaPP), as a promoter of wound healing to improve surgical outcomes.
Design, Setting & Outcome
A double-blinded, randomized control human clinical trial was conducted in patients undergoing ESS as treatment for CRS. Participants underwent functional endoscopic sinus surgery (1) or FESS with drill out (DO) as required and were randomised to receive test product Chitogel, Chitogel in combination with Def or Def-GaPP versus no packing (control). Patients were followed up at 2, 6 and 12 weeks PO, outcome scores such as SNOT-22, VAS and LKS, pre and post-surgery (12 weeks) were compared.
Results
79 patients completed the study, there was a significant reduction in SNOT-22 score and improvement of VAS at 12-week in patients treated with Chitogel compared to control (p<0.05). In those patients, the mean ostium area for the Chitogel and the Chitogel + Def + GaPP groups were higher across all 3 sinuses compared to the no-treatment control group, without statistical significance. Sphenoid sinus ostium was significantly more patent in patients treated with Chitogel compared to control at the 12-week time point (p < 0.05).
Conclusion
Chitogel as a post-operative dressing after ESS results in the best patient reported symptom scores and objective measurements. The combination of Def and GaPP to Chitogel though proving safe, had no effect on the ostium patency or mucosal healing.
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