Topical Tranexamic Acid Application in Rhinoplasty

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

Study Overview

• Status: Completed
• Conditions: Edema; Ecchymosis; Eyelid; Rhinoplasty
• Intervention / Treatment: Drug: Tranexamic acid; Other: Isotonic saline

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey
  • Ankata
    • Cankaya, Ankata, Turkey, 06490
      • Baskent University Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Tranexamic acid; 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	Drug: Tranexamic acid; 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
Placebo Comparator: Isotonic saline; Group Co (n=25): Isotonic saline ( NaCl, 0.9 %) soaked pledgets were placed under the skin flap to cover the osteotomy line	Other: Isotonic saline; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Periorbital Ecchymosis	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.	postoperative 1st day
Periorbital Ecchymosis	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.	postoperative 3rd day
Periorbital Ecchymosis	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.	postoperative 7th day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eyelid edema	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.	postoperative 1st day
Eyelid edema	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.	postoperative 3rd day
Eyelid edema	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.	postoperative 7th day

Collaborators and Investigators

• Sponsor: Baskent University
• Investigators: Principal Investigator: omer vural, Başkent University

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2021
• Primary Completion (Actual): September 17, 2021
• Study Completion (Actual): October 15, 2021

Study Registration Dates

• First Submitted: April 2, 2022
• First Submitted That Met QC Criteria: April 9, 2022
• First Posted (Actual): April 13, 2022

Study Record Updates

• Last Update Posted (Actual): April 13, 2022
• Last Update Submitted That Met QC Criteria: April 9, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: edema; tranexamic acid; ecchymosis; rhinoplasty
• Additional Relevant MeSH Terms: Pathologic Processes; Hematologic Diseases; Hemorrhage; Blood Coagulation Disorders; Skin Manifestations; Edema; Ecchymosis; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: 25ovafbsi

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No