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

NCT06094348 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2023-10-23

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Haseki Training and Research Hospital

    lead OTHER

Principal Investigators

  • Isil Taylan Cebi, M.D · Haseki Training and Research Hospiral

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-19
Primary Completion
2024-04-19
Completion
2024-04-19
FDA Device
Yes

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06094348 on ClinicalTrials.gov