Overview
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.
Description
Postoperative care following functional endoscopic sinus surgery and other endoscopic nasal procedures is important for reducing inflammation, supporting mucosal healing, and preventing complications and disease recurrence.
Conventional topical nasal treatments may be rapidly cleared from the nasal cavity, which may reduce their contact time with the postoperative nasal mucosa.
The investigational formulation contains triamcinolone acetonide incorporated into polymeric nanocapsules prepared using a nanoprecipitation method. The nanocapsule delivery system is intended to improve local drug retention, enhance drug stability, and provide controlled release of triamcinolone acetonide at the postoperative nasal tissues.
Eligible participants will be randomly assigned to receive either topical triamcinolone acetonide-loaded polymeric nanocapsules or standard normal saline nasal irrigation following endoscopic nasal surgery.
Participants will be followed using endoscopic clinical assessments, patient-reported sinonasal symptom questionnaires, evaluation of postoperative complications, and monitoring for local or systemic corticosteroid-related adverse effects.
Eligibility
Inclusion Criteria
- Adults aged 18 to 60 years.
- Patients scheduled to undergo one of the following procedures:
- Functional endoscopic sinus surgery
- Endoscopic turbinoplasty
- Endoscopic septoplasty
- Diagnosis of chronic rhinosinusitis and/or nasal polyps requiring surgical intervention.
- Ability and willingness to provide written informed consent.
- Ability and willingness to comply with study treatment and scheduled follow-up visits.
Exclusion Criteria
- 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.
- Pregnancy or breastfeeding, if excluded in the approved protocol.
- Uncontrolled diabetes mellitus, if corticosteroid exposure is considered clinically relevant.
- Immunosuppression or use of immunosuppressive therapy.
- Recent use of systemic or intranasal corticosteroids within the protocol-defined washout period.
- Participation in another clinical trial.
- Any medical or psychiatric condition that may interfere with informed consent, study treatment, or follow-up.
- Inability to complete the required questionnaires or follow-up visits.
