The Evaluation of Piezo and Endonasal Osteotomy Methods on Postoperative Healing Process in Septorhinoplasty
NCT ID: NCT06094348
Last Updated: 2023-10-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
60 participants
OBSERVATIONAL
2023-05-19
2024-04-19
Brief Summary
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* 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)
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Detailed Description
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* 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).
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Group 1A- Thick skin, endonasal osteotomy
Patients with mean nasal soft tissue envelope thickness \> 4 mm undergoing classical endonasal osteotomy procedure during rhinoplasty operation
Endonasal osteotomy
Patients will undergo median-oblique and lateral osteotomy, with conventional 2 mm guarded, straight osteotome.
Group 1B -Thick skin, piezo osteotomy
Patients with mean nasal soft tissue envelope thickness \> 4 mm undergoing piezosurgery assisted osteotomy procedure during rhinoplasty operation
Piezo assisted osteotomy
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.
Group 2A- Thin skin, endonasal osteotomy
Patients with mean nasal soft tissue envelope thickness \<4 mm undergoing classical endonasal osteotomy procedure during rhinoplasty operation
Endonasal osteotomy
Patients will undergo median-oblique and lateral osteotomy, with conventional 2 mm guarded, straight osteotome.
Group 2B- Thin skin, piezo osteotomy
Patients with mean nasal soft tissue envelope thickness \< 4 mm undergoing piezosurgery assisted osteotomy procedure during rhinoplasty operation
Piezo assisted osteotomy
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.
Interventions
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Endonasal osteotomy
Patients will undergo median-oblique and lateral osteotomy, with conventional 2 mm guarded, straight osteotome.
Piezo assisted osteotomy
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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Haseki Training and Research Hospital
OTHER
Responsible Party
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ISIL TAYLAN CEBI
principal investigator
Principal Investigators
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Isil Taylan Cebi, M.D
Role: PRINCIPAL_INVESTIGATOR
Haseki Training and Research Hospiral
Locations
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Haseki Training and Research Hospital
Istanbul, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
Other Identifiers
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Piezo vs Endonasal osteotomy
Identifier Type: -
Identifier Source: org_study_id
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