Status:
NOT_YET_RECRUITING
Hybrid Osteoplasty Versus Osteotomy in Rhinoplasty
Lead Sponsor:
University of Sulaimani
Conditions:
Rhinoplasty Techniques
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study is designed to compare two common techniques for reducing the nasal hump during rhinoplasty: the traditional method using osteotomes and rasps, and a newer technique called hybrid osteoplas...
Detailed Description
This prospective randomized controlled trial will evaluate the aesthetic and functional outcomes of hybrid osteoplasty using a surgical burr compared with traditional osteotomy and rasping in primary ...
Eligibility Criteria
Inclusion
- Primary open rhinoplasty planned.
- Dorsal hump with bony or mixed component suitable for either technique.
- No prior nasal surgery or significant nasal trauma affecting dorsum.
- ASA I-III and fit for general anesthesia.
- Willing to provide written informed consent, including standardized photography.
- Able and willing to attend all follow-up visits through 12 months.
Exclusion
- Revision rhinoplasty or prior osteotomy/osseocartilaginous work.
- Active infection, open lesions, or uncontrolled dermatologic conditions at operative field.
- Bleeding diathesis, platelet disorder, INR elevation, or anticoagulant/antiplatelet therapy that cannot be paused.
- Uncontrolled systemic disease (e.g., hypertension, diabetes) or ASA ≥ IV.
- Pregnancy or breastfeeding.
- Chronic isotretinoin use within past 6 months or long-term systemic corticosteroid use.
- Concurrent interventional study that may affect healing or outcomes.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT07142525
Start Date
October 1 2025
End Date
December 1 2026
Last Update
October 2 2025
Active Locations (1)
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1
Royal Hospital
Sulaymaniyah, KRI, Iraq, 46001