Topical Tranexamic Acid Application in Rhinoplasty

NCT ID: NCT05326139

Last Updated: 2022-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-07
• Study Completion Date: 2021-10-15

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.

Conditions

Ecchymosis; Eyelid; Edema; Rhinoplasty

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Tranexamic acid

Intervention Type: 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.

Isotonic saline

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

Group Type: PLACEBO_COMPARATOR

Isotonic saline

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: OTHER

Other Intervention Names

Transamin; Mediflex %0.9 NaCl

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baskent University

OTHER

Sponsor Role: lead

Responsible Party

Ömer vural

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

omer vural

Role: PRINCIPAL_INVESTIGATOR

Baskent University

Locations

Baskent University Faculty of Medicine

Çankaya, Ankata, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

25ovafbsi

Identifier Type: -

Identifier Source: org_study_id