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