Topical Tranexamic Acid Application in Rhinoplasty
Condition: Ecchymosis; Eyelid; Edema; Rhinoplasty
MeSH terms: Ecchymosis; Edema
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Tranexamic acid; Isotonic saline
Intervention type(s): Drug; Other
Intervention description(s): 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 -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 intervention name(s): Transamin; Mediflex %0.9 NaCl
Intervention MeSH terms: Tranexamic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: ecchymosis; rhinoplasty; edema; tranexamic acid