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

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06094348
• Other study ID #: Piezo vs Endonasal osteotomy
• Status: Recruiting
• Start date: May 19, 2023
• Est. completion date: April 19, 2024

Study information

• Verified date: October 2023
• Source: Haseki Training and Research Hospital
• Contact: Isil Taylan Cebi, M.D
• Phone: 00905072352256
• Email: drisiltaylan[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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)

Description:

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).

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Nasal Deformity, Acquired
• Nose Deformities, Acquired

Intervention

Procedure:
• Endonasal osteotomy
Patients will undergo median-oblique and lateral osteotomy, with conventional 2 mm guarded, straight osteotome.

Device:
• 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.

Locations

Country	Name	City	State
Turkey	Haseki Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Haseki Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

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

Outcome

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