Topical Tranexamic Acid Application in Rhinoplasty

Phase 4

Completed

• Conditions: Edema; Rhinoplasty; Ecchymosis; Eyelid
• Interventions: Other: Isotonic saline; Drug: Tranexamic acid

• Registration Number: NCT05326139
• Lead Sponsor: Baskent University

Brief Summary

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.

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 Timeline

• Study Start: 2021-06-07
• Primary Completion: 2021-09-17
• Study Completion: 2021-10-15
• Status Verified: 2022-04
• Study First Submitted: 2022-04-02
• Study First Submitted QC: 2022-04-09
• Last Update Submitted: 2022-04-09
• Study First Posted: 2022-04-13
• Last Update Posted: 2022-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Periorbital Ecchymosis	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 Outcome Measures

Name	Time	Method
Eyelid edema	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.

Trial Locations

Locations (1)

Baskent University Faculty of Medicine; 🇹🇷 Cankaya, Ankata, Turkey