Triamcinolone Nanocapsules After Endoscopic Nasal Surgery | NCT07714525

NCT07714525

Overview

NCT ID: NCT07714525
Lead Sponsor: Deraya UniversityOTHER
Official Title: Clinical Evaluation of Triamcinolone Acetonide-loaded Nanoparticles For Nasal Postoperative Application
Brief 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.
Conditions: Chronic Rhinosinusitis (CRS)
Nasal Polyps
Postoperative Healing After Endoscopic Nasal Surgery

Ages Eligible for Study: Adult (18-64)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
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.

Central Contacts: Sally Mansour HelmyContact
aliaa.gamal@deraya.edu.eg+20 102 692 0921