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Completed

NCT Number: NCT05326139

Topical Tranexamic Acid Application in Rhinoplasty

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Baskent University Faculty of Medicine

Çankaya, Ankata, 06490, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Tranexamic Acid

Drug

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.

Other names: Transamin

Isotonic saline

Other

Isotonic saline -soaked pledgets were placed under the skin flap in such a way that both sides reach the osteotomy area and left for 5 minutes.

Other names: Mediflex %0.9 NaCl

Primary outcomes

  1. Periorbital Ecchymosis

    Time frame: postoperative 1st day

    Ecchymosis around the eye as assessed using "4-point periorbital ecchymosis scale". Digital photographs were obtained on the first 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.

  2. Periorbital Ecchymosis

    Time frame: postoperative 3rd day

    Ecchymosis around the eye as assessed using "4-point periorbital ecchymosis scale". Digital photographs were obtained on the third 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.

  3. Periorbital Ecchymosis

    Time frame: 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.

Secondary outcomes

  1. Eyelid edema

    Time frame: postoperative 1st day

    Edema around the eye as assessed using "4-point eyelid edema scale". Digital photographs were obtained on the first postoperative days. Eyelid edema were scored via digital photographs using a graded scale ranging from 0 to 4 point, higher scores mean a worse outcome.

  2. Eyelid edema

    Time frame: postoperative 3rd day

    Edema around the eye as assessed using "4-point eyelid edema scale". Digital photographs were obtained on the third postoperative days. Eyelid edema were scored via digital photographs using a graded scale ranging from 0 to 4 point, higher scores mean a worse outcome.

  3. Eyelid edema

    Time frame: postoperative 7th day

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

Sponsors and collaborators

Lead sponsor

Baskent University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 13, 2022
Registry last updated
Apr 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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