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

October 18, 2023 updated by: ISIL TAYLAN CEBI, Haseki Training and Research Hospital

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)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Abdullah Karatas, Assoc. Prof
  • Phone Number: 00905326230218
  • Email: akrts2000@yahoo.ca

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Recruiting
        • Haseki Training and Research Hospital
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Tuba Selcuk, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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
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.
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
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the mean nasal soft tissue envelope thickness measurements of rhinoplasty patients at postoperative 10th month
Time Frame: 10 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Haseki Training and Research Hospital

Investigators

  • Principal Investigator: Isil Taylan Cebi, M.D, Haseki Training and Research Hospiral

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 19, 2023

Primary Completion (Estimated)

April 19, 2024

Study Completion (Estimated)

April 19, 2024

Study Registration Dates

First Submitted

October 10, 2023

First Submitted That Met QC Criteria

October 18, 2023

First Posted (Actual)

October 23, 2023

Study Record Updates

Last Update Posted (Actual)

October 23, 2023

Last Update Submitted That Met QC Criteria

October 18, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Piezo vs Endonasal osteotomy

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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