Postoperative Nasal Edema. T81.89
Conditions
Interventions
Intervention 1: Intervention group: Monthly triamcinolone injection (6.67 mg/mL at 12 points) for 12 months + oral isotretinoin (10 mg/week for 3 months).Control group: Monthly triamcinolone injection
Sponsors
Shahid Beheshti University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: Male and female patients aged 18 to 50 years Candidates for their first septorhinoplasty surgery Having thick nasal skin as determined by the evaluating physician (based on clinical examination and manual palpation) Possessing relative general health to tolerate surgery and follow-up during the study period Willingness to participate and provide written informed consent Having no known contraindications to triamcinolone or isotretinoin Having a Body Mass Index (BMI) between 18 and 30 Ability and commitment to attend all scheduled follow-up visits
Exclusion criteria
Exclusion criteria: Pregnancy, lactation, or planning pregnancy during the study period History of any prior nasal surgery or fracture History of allergic reaction or known hypersensitivity to triamcinolone, isotretinoin, or their components Active dermatological diseases in the facial area (e.g., severe rosacea, lupus, skin infections) Uncontrolled or severe systemic diseases (e.g., uncontrolled diabetes, cardiac, renal, or hepatic failure) History of severe psychiatric disorders that may affect patient cooperation History of substance or alcohol abuse Smoking (cigarettes, hookah) more than 10 per day Having a Body Mass Index (BMI) less than 18 or greater than 30 Having severe septal deviation requiring complex reconstructive surgery Regular use of systemic corticosteroids or high-dose non-steroidal anti-inflammatory drugs (NSAIDs) prior to surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Nasal edema severity based on a four-grade semi-quantitative scale (0 to 3) determined by the physician assessor. Timepoint: Monthly from one month after surgery until twelve months after surgery. Method of measurement: Clinical assessment by a fixed physician assessor using direct observation and comparison with standardized reference images, based on the following four-grade semi-quantitative scale:Grade 0: No swelling.Grade 1: Mild swelling without change in nasal contour.Grade 2: Moderate swelling with mild change in the dorsal line.Grade 3: Severe swelling with obvious protrusion in the profile view.;Duration (in days) from the surgery date until the time when nasal edema severity first reduces to grade 0 (no swelling) or grade 1 (mild swelling without contour change) on the four-grade semi-quantitative scale and remains stable over two consecutive monthly visits. Timepoint: Monthly assessment from one month after surgery until twelve months after surgery (or until the defined endpoint is reached). Method of measurement: Recording the date of each monthly visit and the edema grade documented at that visit by the physician assessor. Calculating the duration by counting the days between the surgery date and the date of the first visit where the criteria for sustained improvement (grade 0 or 1 in two consecutive visits) are met. | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of treatment-related adverse events. Timepoint: Monthly from the intervention start (one month after surgery) until the end of the twelfth month after surgery. Method of measurement: Recording any untoward medical occurrence (local complications such as skin atrophy, pigmentary changes, or systemic side effects) through direct patient questioning, clinical examination by the physician, and review of the patient's medical records. Adverse events are categorized based on severity (mild, moderate, severe) and relation to the study drugs (definitely related, probably related, unrelated).;Patient satisfaction with the aesthetic outcome of the nose. Timepoint: At the end of the twelfth month after surgery. Method of measurement: Using a standardized patient satisfaction questionnaire with a 5-point Likert scale (from "Very Dissatisfied" to "Very Satisfied") or a 100-millimeter Visual Analogue Scale, completed by the patient themselves. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMohammad Sezavar
Shahid Beheshti University of Medical Sciences
Outcome results
None listed