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临床试验/NCT06094348
NCT06094348招募中不适用

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

Haseki Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年5月19日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
the mean nasal soft tissue envelope thickness measurements of rhinoplasty patients at postoperative 10th month

研究概览

简要总结

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)

详细描述

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).

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

the mean nasal soft tissue envelope thickness measurements of rhinoplasty patients at postoperative 10th month

时间窗: 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

次要结局

未报告次要终点

研究者

发起方
Haseki Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

ISIL TAYLAN CEBI

principal investigator

Haseki Training and Research Hospital

研究点 (1)

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