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Topical Tranexamic Acid Application in Rhinoplasty

Primary Purpose

Ecchymosis; Eyelid, Edema, Rhinoplasty

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Tranexamic acid
Isotonic saline
Sponsored by
Baskent University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Ecchymosis; Eyelid focused on measuring ecchymosis, rhinoplasty, edema, tranexamic acid

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Baskent University Faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Tranexamic acid

Isotonic saline

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
April 2, 2022
Last Updated
April 9, 2022
Sponsor
Baskent University
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1. Study Identification

Unique Protocol Identification Number
NCT05326139
Brief Title
Topical Tranexamic Acid Application in Rhinoplasty
Official Title
The Effect of Topical Tranexamic Acid Application on Postoperative Periorbital Ecchymosis and Eyelid Edema in Rhinoplasty
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
June 7, 2021 (Actual)
Primary Completion Date
September 17, 2021 (Actual)
Study Completion Date
October 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baskent University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ecchymosis; Eyelid, Edema, Rhinoplasty
Keywords
ecchymosis, rhinoplasty, edema, tranexamic acid

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tranexamic acid
Arm Type
Active Comparator
Arm Description
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
Arm Title
Isotonic saline
Arm Type
Placebo Comparator
Arm Description
Group Co (n=25): Isotonic saline ( NaCl, 0.9 %) soaked pledgets were placed under the skin flap to cover the osteotomy line
Intervention Type
Drug
Intervention Name(s)
Tranexamic acid
Other Intervention Name(s)
Transamin
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Isotonic saline
Other Intervention Name(s)
Mediflex %0.9 NaCl
Intervention Description
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.
Primary Outcome Measure Information:
Title
Periorbital Ecchymosis
Description
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.
Time Frame
postoperative 1st day
Title
Periorbital Ecchymosis
Description
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.
Time Frame
postoperative 3rd day
Title
Periorbital Ecchymosis
Description
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.
Time Frame
postoperative 7th day
Secondary Outcome Measure Information:
Title
Eyelid edema
Description
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.
Time Frame
postoperative 1st day
Title
Eyelid edema
Description
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.
Time Frame
postoperative 3rd day
Title
Eyelid edema
Description
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.
Time Frame
postoperative 7th day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
omer vural
Organizational Affiliation
Baskent University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baskent University Faculty of Medicine
City
Cankaya
State/Province
Ankata
ZIP/Postal Code
06490
Country
Turkey

12. IPD Sharing Statement

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Topical Tranexamic Acid Application in Rhinoplasty

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