This randomised, single-masked, parallel-group clinical trial will evaluate the efficacy and safety of a topical triamcinolone acetonide-loaded polymeric nanocapsule formulation for postoperative care following endoscopic nasal surgery.
Participants will receive either the investigational triamcinolone acetonide-loaded nanocapsule formulation or standard normal saline nasal irrigation. Postoperative nasal healing, inflammation, patient-reported sinonasal symptoms, postoperative complications, and corticosteroid-related adverse effects will be compared between the two groups.
Adults aged 18 to 60 years.
Functional endoscopic sinus surgery
Endoscopic turbinoplasty
Endoscopic septoplasty
Known hypersensitivity to triamcinolone acetonide.
Known hypersensitivity to any component of the polymeric nanocapsule formulation.
Systemic contraindication to corticosteroid therapy.
Active severe nasal or sinonasal infection at the time of enrollment or treatment.
Parallel
Triamcinolone Acetonide-Loaded Polymeric Nanocapsules
DrugTriamcinolone acetonide incorporated into polymeric nanocapsules prepared using a nanoprecipitation method will be administered topically to the postoperative nasal cavity.
Normal Saline Nasal Irrigation
Other interventionParticipants will receive postoperative nasal irrigation with 0.9% sodium chloride solution.
Change in Lund-Kennedy Endoscopic Score
The Lund-Kennedy Endoscopic Score will be used to assess postoperative nasal mucosal healing and inflammation. The score ranges from 0 to 20 and is calculated by summing the scores for polyps, discharge, oedema, scarring, and crusting (each scored 0-2 on both the left and right sides). A total score of 0 indicates no disease, and a score of 20 indicates the most severe disease. Therefore, higher scores indicate a worse outcome
Change in 22-Item Sinonasal Outcome Test Score (SNOT-22)
SNOT-22 will be used to assess participant-reported sinonasal symptoms and health-related quality of life. The total score ranges from 0 to 110 and is calculated by summing the scores for 22 individual items. Each item is rated from 0 ("No problem") to 5 ("Problem as bad as it can be"). A total score of 0 indicates no disease burden, and a score of 110 indicates the maximum disease burden. Therefore, higher scores indicate a worse outcome.
Incidence of Postoperative Complications
The number and percentage of participants experiencing protocol-defined postoperative complications will be recorded.
Incidence of Corticosteroid-Related Adverse Events
The number and percentage of participants experiencing local or systemic adverse events considered related to topical triamcinolone acetonide will be recorded.
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