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Triamcinolone Nanocapsules After Endoscopic Nasal Surgery

RecruitingPhase 2

Sponsor: Deraya University

Conditions: Chronic Rhinosinusitis (CRS), Nasal Polyps, Postoperative Healing After Endoscopic Nasal Surgery

Interventions: Triamcinolone Acetonide-Loaded Polymeric Nanocapsules, Normal Saline Nasal Irrigation

Countries: Egypt

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 overview

Sex: ALL

Age: 18 Years to 60 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (1)

Minya, Menia Governorate, Egypt