The Evaluation of Piezo and Endonasal Osteotomy Methods on Postoperative Healing Process in Septorhinoplasty

Study Overview
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Brief Summary
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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)

Detailed Description
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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? 18-65 years old males or females with nasal septum and/or nasal pyramid deviation and external nasal deformities who are willing to undergo open rhinoplasty procedure will be included in the study. Patients who have a history of previous rhinoplasty/septorhinoplasty procedure, abnormal coagulation parameters (prothrombin time, partial thromboplastin time, bleeding/coagulation time), use of anticoagulant drugs, chronic / inflammatory skin disease and/or chronic skin allergies, systemic diseases (hypertension, diabetes mellitus, bronchial asthma), nasal beautification procedures such as dermal fillings, using oral and/or topical (nasal skin) corticosteroids in three months preoperatively will be excluded. 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).

Official Title
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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

Conditions
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Nasal Deformity, Acquired, Septum; Deviation, Congenital

Intervention / Treatment
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* Procedure: Endonasal osteotomy
* Device: Piezo assisted osteotomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1A- Thick skin, endonasal osteotomy<br>Patients with mean nasal soft tissue envelope thickness > 4 mm undergoing classical endonasal osteotomy procedure during rhinoplasty operation | Procedure: Endonasal osteotomy<br>* Patients will undergo median-oblique and lateral osteotomy, with conventional 2 mm guarded, straight osteotome.<br>|
| Group 1B -Thick skin, piezo osteotomy<br>Patients with mean nasal soft tissue envelope thickness > 4 mm undergoing piezosurgery assisted osteotomy procedure during rhinoplasty operation | Device: Piezo assisted osteotomy<br>* Piezo is a system for cutting bone with micrometric ultrasonic piezoelectric vibrations, with varying frequency and cutting energy. The device consists of a platform with a powerful piezoelectric hand piece and employs a functional frequency between 25-29 kHz. The device is fitted with a cooling irrigation system with a 0-60 cc/min variable sterile solution flow. Specific inserts and scalpels act in a linear vibration pattern, with a spatial range between 60 and 210 microns, moved by an ultrasonic power that exceeds 5 watts, reaching up to 16 watts.<br>|
| Group 2A- Thin skin, endonasal osteotomy<br>Patients with mean nasal soft tissue envelope thickness <4 mm undergoing classical endonasal osteotomy procedure during rhinoplasty operation | Procedure: Endonasal osteotomy<br>* Patients will undergo median-oblique and lateral osteotomy, with conventional 2 mm guarded, straight osteotome.<br>|
| Group 2B- Thin skin, piezo osteotomy<br>Patients with mean nasal soft tissue envelope thickness < 4 mm undergoing piezosurgery assisted osteotomy procedure during rhinoplasty operation | Device: Piezo assisted osteotomy<br>* Piezo is a system for cutting bone with micrometric ultrasonic piezoelectric vibrations, with varying frequency and cutting energy. The device consists of a platform with a powerful piezoelectric hand piece and employs a functional frequency between 25-29 kHz. The device is fitted with a cooling irrigation system with a 0-60 cc/min variable sterile solution flow. Specific inserts and scalpels act in a linear vibration pattern, with a spatial range between 60 and 210 microns, moved by an ultrasonic power that exceeds 5 watts, reaching up to 16 watts.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rhinoplasty, edema, piezosurgery, osteotomy