Ecchymosis; EyelidPhase 4NCT05326139
Topical Tranexamic Acid Application in Rhinoplasty
A Phase 4 study testing Tranexamic acid and Isotonic saline in people with Ecchymosis; Eyelid and Edema, run by Baskent University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Ecchymosis; Eyelid, Edema, Rhinoplasty
- What is being tested?
- Tranexamic acid and Isotonic saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Jun 2021to 15 Oct 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- primary open approach rhinoplasty under general anesthesia
- bilateral lateral osteotomies
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Baskent University Faculty of Medicine
Çankaya, Ankata, 06490
About this study
Official title: The Effect of Topical Tranexamic Acid Application on Postoperative Periorbital Ecchymosis and Eyelid Edema in Rhinoplasty
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.
Read the 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
- Being tested
- Tranexamic acid, Isotonic saline
- Keywords
- ecchymosis, rhinoplasty, edema, tranexamic acid
- Medical subject headings
- Ecchymosis, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acidDrug
Also called Transamin
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 salineOther
Also called Mediflex %0.9 NaCl
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Isotonic saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: postoperative 7th day
Secondary outcomes (3)
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.
Measured: postoperative 1st day
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.
Measured: postoperative 3rd day
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.
Measured: postoperative 7th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2022
- Study start7 Jun 2021
- Primary completion17 Sep 2021
- Study completion15 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ecchymosis; EyelidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ömer vural, Baskent University
- Investigators
- omer vural, Principal investigator, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05326139
- Sponsor's protocol ID
- 25ovafbsi
- Status last verified
- Apr 2022
- First submitted
- 2 Apr 2022
- Last updated
- 13 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Topical Tranexamic Acid Application on Postoperative Periorbital Ecchymosis and Eyelid Edema in Rhinoplasty
- ClinicalTrials.gov ID
- NCT05326139
- Acronym / sponsor ID
- 25ovafbsi
- Conditions
- Ecchymosis; Eyelid, Edema, Rhinoplasty
- Keywords
- ecchymosis, rhinoplasty, edema, tranexamic acid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- 7 Jun 2021 (actual)
- Primary completion
- 17 Sep 2021 (actual)
- Study completion
- 15 Oct 2021 (actual)
- First posted
- 13 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tranexamic acid | Active comparator | Drug: Tranexamic acidGroup TA (n=25): TA ( Tranexamic acid, 250mg/2.5 ml inj ) soaked pledgets were placed under the skin flap to cover the osteotomy line |
| Isotonic saline | Placebo comparator | Other: Isotonic salineGroup Co (n=25): Isotonic saline ( NaCl, 0.9 %) soaked pledgets were placed under the skin flap to cover the osteotomy line |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- primary open approach rhinoplasty under general anesthesia
- bilateral lateral osteotomies
Key exclusion criteria (6 listed)
- Patients younger than 18 years
- Patients older than 60 years
- history of previous nasal operations
- chronic medical conditions,
- hematologic disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranexamic acidAlso: TransaminTA-soaked pledgets were placed under the skin flap in such a way that both sides reach the osteotomy area and left for 5 minutes. | Drug | Tranexamic acid |
| Isotonic salineAlso: Mediflex %0.9 NaClIsotonic 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 | Isotonic saline |
Primary outcome
Periorbital Ecchymosis
Time frame: postoperative 1st day
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
Time frame: postoperative 3rd day
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
Time frame: 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.
3 secondary outcomes
Eyelid edema
Time frame: postoperative 1st day
Eyelid edema
Time frame: postoperative 3rd day
Eyelid edema
Time frame: postoperative 7th day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2022.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
omer vural principal investigator
Baskent University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tranexamic acid and Isotonic saline in people with Ecchymosis; Eyelid and Edema, run by Baskent University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Periorbital Ecchymosis (time frame: postoperative 1st day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2022.