Triamcinolone Nanocapsules After Endoscopic Nasal Surgery

Condition(s) studied

Investigational drug(s) / intervention(s)

Triamcinolone Acetonide-Loaded Polymeric Nanocapsules: Triamcinolone acetonide incorporated into polymeric nanocapsules prepared using a nanoprecipitation method will be administered topically to the postoperative nasal cavity.

Normal Saline Nasal Irrigation: Participants will receive postoperative nasal irrigation with 0.9% sodium chloride solution.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Change in Lund-Kennedy Endoscopic Score — Baseline, postoperative week 2, postoperative week 4, and postoperative month 3
  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) — Baseline, postoperative week 2, postoperative week 4, and postoperative month 3
  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.

Trial sites (1)

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