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

Last updated: October 18, 2023
Sponsor: Haseki Training and Research Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Piezo assisted osteotomy

Endonasal osteotomy

Clinical Study ID

NCT06094348
Piezo vs Endonasal osteotomy
  • Ages 18-65
  • All Genders

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)

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • previous rhinoplasty/septorhinoplasty procedure
  • patients with abnormal coagulation parameters (prothrombin time, partialthromboplastin 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 Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Piezo assisted osteotomy
Phase:
Study Start date:
May 19, 2023
Estimated Completion Date:
April 19, 2024

Study 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).

Connect with a study center

  • Haseki Training and Research Hospital

    Istanbul,
    Turkey

    Active - Recruiting

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