Nasal Deformity, Acquired Clinical Trial
Official title:
The Evaluation of the Effect of Piezo and Endonasal Osteotomy Methods on Postoperative Healing Process in Septorhinoplasty by the Ultrasonic Measurement of Nasal Skin Thickness
The goal of this observational study is to compare the effect of Piezo and endonasal osteotomy techniques on the healing process of patients undergoing septorhinoplasty surgery. The main question[s] it aims to answer are: - In which osteotomy technique the edema is lesser? - Which osteotomy technique is better for thick vs thin skinned patients ? In which osteotomy technique the healing process is faster? Participants will be asked to have an ultrasonic measurement of the nasal dorsum preoperatively and at the first, third and tenth months postoperatively. Researchers will compare the thick and thin skinned patients to detect which osteotomy technique is superior in the healing process ( lesser edema and faster healing due to skin thickness measurements)
Status | Recruiting |
Enrollment | 60 |
Est. completion date | April 19, 2024 |
Est. primary completion date | April 19, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - nasal respiratory dysfunction with the deviation of nasal septum and/or the nasal pyramid Exclusion Criteria: - previous rhinoplasty/septorhinoplasty procedure - patients with abnormal coagulation parameters (prothrombin time, partial thromboplastin time, bleeding/coagulation time) - use of anticoagulant drugs - chronic / inflammatory skin disease and/or chronic skin allergies - presence of systemic diseases (hypertension, diabetes mellitus, bronchial asthma) - nasal beautification procedures such as dermal fillings - use of oral and/or topical (nasal skin) corticosteroids in three months preoperatively |
Country | Name | City | State |
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Turkey | Haseki Training and Research Hospital | Istanbul |
Lead Sponsor | Collaborator |
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Haseki Training and Research Hospital |
Turkey,
Erdur ZB, Oktem F, Inci E, Yener HM, Ustundag A. Effect of Nasal Soft-Tissue Envelope Thickness on Postoperative Healing Process Following Rhinoplasty. J Craniofac Surg. 2021 Sep 1;32(6):2193-2197. doi: 10.1097/SCS.0000000000007697. — View Citation
Gode S, Ozturk A, Kismali E, Berber V, Turhal G. The Effect of Platelet-Rich Fibrin on Nasal Skin Thickness in Rhinoplasty. Facial Plast Surg. 2019 Aug;35(4):400-403. doi: 10.1055/s-0039-1693436. Epub 2019 Jul 15. — View Citation
Kurt Yazar S, Serin M, Rakici IT, Sirvan SS, Irmak F, Yazar M. Comparison of piezosurgery, percutaneous osteotomy, and endonasal continuous osteotomy techniques with a caprine skull model. J Plast Reconstr Aesthet Surg. 2019 Jan;72(1):107-113. doi: 10.1016/j.bjps.2018.08.025. Epub 2018 Sep 4. — View Citation
Stenner M, Koopmann M, Rudack C. Measuring the nose in septorhinoplasty patients: ultrasonographic standard values and clinical correlations. Eur Arch Otorhinolaryngol. 2017 Feb;274(2):855-860. doi: 10.1007/s00405-016-4296-7. Epub 2016 Sep 15. — View Citation
Tsikopoulos A, Tsikopoulos K, Doxani C, Vagdatli E, Meroni G, Skoulakis C, Stefanidis I, Zintzaras E. Piezoelectric or Conventional Osteotomy in Rhinoplasty? A Systematic Review and Meta-Analysis of Clinical Outcomes. ORL J Otorhinolaryngol Relat Spec. 2020;82(4):216-234. doi: 10.1159/000506707. Epub 2020 Apr 22. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | the mean nasal soft tissue envelope thickness measurements of rhinoplasty patients at postoperative 10th month | the mean nasal soft tissue envelope thickness measurements of rhinoplasty patients at postoperative 10 th month will be done by ultrasonography at four anatomic locations; these locations are nasion, rhinion, supratip and tip | 10 months |
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