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

NCT06094348 | Unknown FDA Device

• 1 other identifier: Piezo vs Endonasal osteotomy
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Nasal Deformity, Acquired; Septum; Deviation, Congenital

Keywords

rhinoplasty; edema; piezosurgery; osteotomy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

Group 1A- Thick skin, endonasal osteotomy

Patients with mean nasal soft tissue envelope thickness \> 4 mm undergoing classical endonasal osteotomy procedure during rhinoplasty operation

Procedure: Endonasal osteotomy

Group 1B -Thick skin, piezo osteotomy

Patients with mean nasal soft tissue envelope thickness \> 4 mm undergoing piezosurgery assisted osteotomy procedure during rhinoplasty operation

Device: Piezo assisted osteotomy

Group 2A- Thin skin, endonasal osteotomy

Patients with mean nasal soft tissue envelope thickness \<4 mm undergoing classical endonasal osteotomy procedure during rhinoplasty operation

Procedure: Endonasal osteotomy

Group 2B- Thin skin, piezo osteotomy

Patients with mean nasal soft tissue envelope thickness \< 4 mm undergoing piezosurgery assisted osteotomy procedure during rhinoplasty operation

Device: Piezo assisted osteotomy

Interventions

Endonasal osteotomy PROCEDURE

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

Group 1A- Thick skin, endonasal osteotomy; Group 2A- Thin skin, endonasal osteotomy

Piezo assisted osteotomy DEVICE

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 1B -Thick skin, piezo osteotomy; Group 2B- Thin skin, piezo osteotomy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

18-65 year, males or females with nasal septum and/or nasal pyramid deviation and external nasal deformities who are willing to undergo open rhinoplasty procedure.

You may qualify if:

• nasal respiratory dysfunction with the deviation of nasal septum and/or the nasal pyramid

You may not qualify if:

• 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

Sponsors & Collaborators

• Haseki Training and Research Hospital: lead

Study Sites (1)

Haseki Training and Research Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

Related Publications (5)

• 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.

  PMID: 31307096 BACKGROUND

• 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.

  PMID: 33867511 BACKGROUND

• 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.

  PMID: 27628964 BACKGROUND

• 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.

  PMID: 32320977 BACKGROUND

• 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.

  PMID: 30243555 BACKGROUND

MeSH Terms

Conditions

Nose Deformities, Acquired; Edema

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Isil Taylan Cebi, M.D

  Haseki Training and Research Hospiral

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Isil Taylan Cebi, M.D

CONTACT

00905072352256; drisiltaylan@hotmail.com

Abdullah Karatas, Assoc. Prof

CONTACT

00905326230218; akrts2000@yahoo.ca

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: October 10, 2023
• First Posted: October 23, 2023
• Study Start: May 19, 2023
• Primary Completion: April 19, 2024
• Study Completion: April 19, 2024
• Last Updated: October 23, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)