NCT05326139

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2021

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 7, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 17, 2021

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 2, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 13, 2022

Completed
Last Updated

April 13, 2022

Status Verified

April 1, 2022

Enrollment Period

3 months

First QC Date

April 2, 2022

Last Update Submit

April 9, 2022

Conditions

Ecchymosis; EyelidEdemaRhinoplasty

Keywords

ecchymosisrhinoplastyedematranexamic acid

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (3)

  • Eyelid edema

    postoperative 1st day

  • Eyelid edema

    postoperative 3rd day

  • Eyelid edema

    postoperative 7th day

Study Arms (2)

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

Drug: Tranexamic acid

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

Other: Isotonic saline

Interventions

Tranexamic acidDRUG

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.

Also known as: Transamin
Tranexamic acid
Isotonic salineOTHER

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.

Also known as: Mediflex %0.9 NaCl
Isotonic saline

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baskent University Faculty of Medicine

Çankaya, Ankata, 06490, Turkey (Türkiye)

Location

MeSH Terms

Conditions

EcchymosisEdema

Interventions

Tranexamic AcidSodium Chloride

Condition Hierarchy (Ancestors)

Blood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsSkin ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • omer vural

    Baskent University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 2, 2022

First Posted

April 13, 2022

Study Start

June 7, 2021

Primary Completion

September 17, 2021

Study Completion

October 15, 2021

Last Updated

April 13, 2022

Record last verified: 2022-04

Locations

TU(1)