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临床试验/NCT05326139
NCT05326139已完成4 期

The Effect of Topical Tranexamic Acid Application on Postoperative Periorbital Ecchymosis and Eyelid Edema in Rhinoplasty

Baskent University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年6月7日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
50
试验地点
1
主要终点
Periorbital Ecchymosis

研究概览

简要总结

The aim of this study is to examine the effectiveness of topical Tranexamic acid application in overcoming periorbital ecchymosis and edema after rhinoplasty, which are common and do not have a standard treatment.

详细描述

All patients were informed individually about the procedures and written informed consent was obtained before the study. Patients who underwent rhinoplasty / septorhinoplasty operation between June 2021 and September 2021 with open technique were included in the study. Two groups with at least 25 individuals in each group were included in the study. Patients were appointed to either the control or TA group in a randomized-consecutive fashion. Patients younger than 18 years or older than 60 years, patients with a history of previous nasal operations, chronic medical conditions, hematologic disorders, fibrinolytic disorders and known allergy to tranexamic acid were excluded from the study. In group TA, TA-soaked pledgets were placed under the skin flap in such a way that both sides reach the osteotomy area and left for 5 minutes. In control group, isotonic saline-soaked pledgets were placed under the skin flap in the same way and left for 5 minutes. Surgical pledgets were prepared by nurse and given to the surgeon who did not know which group the pledget belonged to. Digital photographs were obtained by the surgeon who performed the operation on the first, third and seventh postoperative days. Eyelid edema and periorbital ecchymosis were scored via digital photographs separately by two expert surgeons at our institution independently using a graded scale ranging from 0 to 4. Digital photographs of the patients were shown to the examiners in alphabetical order, and information on which groups the patients belonged to was not given. The scores obtained from two different examiners were averaged. Statistical analyses were performed using IBM SPSS for Windows (IBM Corp., version 26.0, Armonk, NY, USA). The gender distribution of the groups was presented by number and percentage. Age, ecchymosis and edema degrees were presented by mean ± SD and median (minimum-maximum) values. The Chi-square test was used to compare the gender distribution of the groups. The patients' ecchymosis and edema scores were compared among groups using a Mann-Whitney U test. Comparisons within each group was evaluated with repeated measures analysis of variance test (Friedman test); if a difference was detected, the Wilcoxon signed rank test with Bonferroni correction was used to determine the group that made a difference. P ≤ .05 was considered statistically significant.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • primary open approach rhinoplasty under general anesthesia
  • bilateral lateral osteotomies

排除标准

  • Patients younger than 18 years
  • Patients older than 60 years
  • history of previous nasal operations
  • chronic medical conditions,
  • hematologic disorders
  • known allergy to tranexamic acid

研究组 & 干预措施

Tranexamic acid

Active Comparator

Group TA (n=25): TA ( Tranexamic acid, 250mg/2.5 ml inj ) soaked pledgets were placed under the skin flap to cover the osteotomy line

干预措施: Tranexamic acid (Drug)

Isotonic saline

Placebo Comparator

Group Co (n=25): Isotonic saline ( NaCl, 0.9 %) soaked pledgets were placed under the skin flap to cover the osteotomy line

干预措施: Isotonic saline (Other)

结局指标

主要结局

Periorbital Ecchymosis

时间窗: postoperative 7th day

Ecchymosis around the eye as assessed using "4-point periorbital ecchymosis scale". Digital photographs were obtained on the seventh postoperative days. Periorbital ecchymosis were scored via digital photographs using a graded scale ranging from 0 to 4 point, higher scores mean a worse outcome.

次要结局

  • Eyelid edema(postoperative 7th day)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ömer vural

Principal Investigator

Baskent University

研究点 (1)

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