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Recruiting NCT07714525

Triamcinolone Nanocapsules After Endoscopic Nasal Surgery

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

Sex: All
Ages: 18 Years – 60 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 50
Sponsor: Deraya University

Location: Deraya university, faculty of pharmacy Minya Menia Governorate

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 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07714525). StuddyBuddy aggregates publicly available trial information.