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
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
- 否
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
ISIL TAYLAN CEBI
principal investigator
Haseki Training and Research Hospital
