Effect of Postoperative Topical St. John's Wort Oil (Hypericum Perforatum) on Periorbital Edema and Ecchymosis Following RhinoplastyNCT07448051
THE EFFECT OF ST. JOHN'S WORT OİL APPLİCATİON ON PERIORBITAL EDEMA AND ECCHYMOSİS AFTER RHİNOPLASTY
A study testing Topical St. John's Wort oil application in people with Effect of Postoperative Topical St. John's Wort Oil (Hypericum Perforatum) on Periorbital Edema and Ecchymosis Following Rhinoplasty, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
Rhinoplasty is one of the most frequently performed procedures in aesthetic and reconstructive surgery, with steadily increasing demand worldwide. Periorbital ecchymosis and edema are common early postoperative complications, primarily resulting from soft tissue hemorrhage during osteotomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Effect of Postoperative Topical St. John's Wort Oil (Hypericum Perforatum) on Periorbital Edema and Ecchymosis Following Rhinoplasty
- What is being tested?
- Topical St. John's Wort oil application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Feb 2026to 27 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing aesthetic or functional rhinoplasty. Aged 18 years or older. Not receiving anticoagulant therapy. No known hematological disorders. No fibrinolytic disorders. No allergy to St. John's Wort oil (Hypericum perforatum) or any of its components.
- Undergoing surgery with the same surgical technique. No communication difficulties. No psychiatric diagnoses. First-time rhinoplasty patients.
Who cannot join
- Undergoing rhinoplasty due to trauma. Diagnosed with diabetes mellitus. Diagnosed with hypertension. Current smokers. Having a psychiatric diagnosis. Allergic to St. John's Wort oil (Hypericum perforatum) or any of its components.
- Using anticoagulant therapy. Having hematological disorders. Having fibrinolytic disorders. Using medications metabolized by CYP3A4, CYP2C9, or CYP2C19. Using medications containing oral contraceptives, antidepressants, or theophylline.
- Scheduled for organ transplantation within the next two months.
Trial locations and contacts
1 site in 1 country.
About this study
Rhinoplasty is one of the most frequently performed procedures in aesthetic and reconstructive surgery, with steadily increasing demand worldwide. Periorbital ecchymosis and edema are common early postoperative complications, primarily resulting from soft tissue hemorrhage during osteotomy. Although these findings are considered part of the natural postoperative course, they may negatively affect patient comfort and satisfaction, particularly in young individuals with high aesthetic expectations. St. John's Wort (Hypericum perforatum) has been reported to possess anti-inflammatory, anti-edematous, and antispasmodic properties. This study aims to evaluate the effect of topical St. John's Wort oil on postoperative periorbital edema and ecchymosis in patients undergoing rhinoplasty.
Methods
Read more
This randomized controlled experimental study will be conducted in a university hospital setting. The study population will consist of patients scheduled for rhinoplasty, and the sample will include those who provide informed consent. Participants will be randomly assigned to either the experimental group (n = 55) or the control group (n = 55). In addition to routine postoperative care, the experimental group will receive topical St. John's Wort oil application, while the control group will receive routine care alone. Data will be collected using a Personal Information Form, the Upper and Lower Eyelid Ecchymosis Assessment Scale, and the Eyelid Edema Assessment Scale. Assessments will be performed on postoperative Day 0, Day 1 (24 hours), Day 3 (72 hours), and Day 7 (168 hours). Statistical analyses will be conducted using SPSS version 25. Data distribution will be assessed for normality, and appropriate parametric or non-parametric tests will be applied. Statistical significance will be set at p < 0.05.
Results
It is anticipated that patients receiving topical St. John's Wort oil will demonstrate significantly lower periorbital edema and ecchymosis scores compared to the control group during the early postoperative period.
Conclusion
Given the role of soft tissue hemorrhage in the development of postoperative ecchymosis and edema, and considering the documented pharmacological properties of St. John's Wort, topical application may represent a safe and effective adjunctive intervention for reducing periorbital complications following rhinoplasty. Further clinical evidence may support its integration into routine postoperative care protocols.
Aim of the Study
The aim of this study is to investigate the effect of St. John's Wort oil (Hypericum perforatum) on postoperative periorbital edema and ecchymosis in patients undergoing rhinoplasty.
Hypotheses
H0a (Null Hypothesis):
St. John's Wort oil (Hypericum perforatum) has no effect on postoperative periorbital edema following rhinoplasty.
H1a (Alternative Hypothesis):
St. John's Wort oil (Hypericum perforatum) has a significant effect on postoperative periorbital edema following rhinoplasty.
H0b (Null Hypothesis):
St. John's Wort oil (Hypericum perforatum) has no effect on postoperative periorbital ecchymosis following rhinoplasty.
H1b (Alternative Hypothesis):
St. John's Wort oil (Hypericum perforatum) has a significant effect on postoperative periorbital ecchymosis following rhinoplasty.
- Being tested
- Topical St. John's Wort oil application
- Keywords
- Rhinoplasti, Ecchymosis, Edema
- Medical subject headings
- Ecchymosis, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical St. John's Wort oil applicationOther
Considering the beneficial effects of St. John's Wort oil, the study aims to accelerate patients' return to normal daily activities after surgery by more rapidly reducing aesthetic concerns and postoperative complications.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Patients undergoing rhinoplasty will provide verbal and written consent, and the experimental group will undergo a preoperative patch test for St. John's Wort oil (Hypericum perforatum) allergy. Postoperatively, patients will receive routine cold application followed by bilateral topical St. John's Wort oil. On the day of surgery, three applications will be administered at 4-hour intervals, continuing three times daily for seven days at home.
Periorbital edema and ecchymosis will be assessed at 1 and 24 hours postoperatively through direct observation, and on Days 3 and 7 via digital photographs. Both the researcher and clinical nurse will independently score each eye using standardized criteria. Data will be analyzed to evaluate the effect of St. John's Wort oil on postoperative periorbital complications. Receives: Other: Topical St. John's Wort oil application |
| Control group | No intervention | During the preoperative period, patients will be introduced to the study, provided with detailed information, and both verbal and written informed consent will be obtained. After introducing the data collection tools, the researcher will complete the Personal Information Data Form. Postoperatively (considered Day 0), periorbital edema and ecchymosis scores will be recorded at four time points: 1 hour, 24 hours (Day 1), 72 hours (Day 3), and 168 hours (Day 7) using the Upper and Lower Eyelid Ecchymosis Assessment Scale and the Eyelid Edema Assessment Scale. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periorbital edema and ecchymosis score
Periorbital edema and ecchymosis score: A standardized clinical scale used to quantify the severity of swelling (edema) and bruising (ecchymosis) around the upper and lower eyelids following surgery.
Measured: Within the first week after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start27 Feb 2026
- Primary completion27 Jun 2026 (estimated)
- Study completion27 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effect of Postoperative Topical St. John's Wort Oil (Hypericum Perforatum) on Periorbital Edema and Ecchymosis Following RhinoplastyStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Şirin URUÇ DEMİR, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07448051
- Sponsor's protocol ID
- 2024/6259
- Status last verified
- Feb 2026
- First submitted
- 26 Feb 2026
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Effect of postoperative topical St. John's Wort oil (Hypericum perforatum) on periorbital edema and ecchymosis following rhinoplasty
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECT OF ST. JOHN'S WORT OİL APPLİCATİON ON PERIORBITAL EDEMA AND ECCHYMOSİS AFTER RHİNOPLASTY
- ClinicalTrials.gov ID
- NCT07448051
- Acronym / sponsor ID
- 2024/6259
- Keywords
- Rhinoplasti, Ecchymosis, Edema
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 27 Feb 2026 (actual)
- Primary completion
- 27 Jun 2026 (estimated)
- Study completion
- 27 Jul 2026 (estimated)
- First posted
- 4 Mar 2026 (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.
Rhinoplasty is one of the most frequently performed procedures in aesthetic and reconstructive surgery, with steadily increasing demand worldwide. Periorbital ecchymosis and edema are common early postoperative complications, primarily resulting from soft tissue hemorrhage during osteotomy. Although these findings are considered part of the natural postoperative course, they may negatively affect patient comfort and satisfaction, particularly in young individuals with high aesthetic expectations. St. John's Wort (Hypericum perforatum) has been reported to possess anti-inflammatory, anti-edematous, and antispasmodic properties. This study aims to evaluate the effect of topical St. John's Wort oil on postoperative periorbital edema and ecchymosis in patients undergoing rhinoplasty.
Methods
This randomized controlled experimental study will be conducted in a university hospital setting. The study population will consist of patients scheduled for rhinoplasty, and the sample will include those who provide informed consent. Participants will be randomly assigned to either the experimental group (n = 55) or the control group (n = 55). In addition to routine postoperative care, the experimental group will receive topical St. John's Wort oil application, while the control group will receive routine care alone. Data will be collected using a Personal Information Form, the Upper and Lower Eyelid Ecchymosis Assessment Scale, and the Eyelid Edema Assessment Scale. Assessments will be performed on postoperative Day 0, Day 1 (24 hours), Day 3 (72 hours), and Day 7 (168 hours). Statistical analyses will be conducted using SPSS version 25. Data distribution will be assessed for normality, and appropriate parametric or non-parametric tests will be applied. Statistical significance will be set at p < 0.05.
Results
It is anticipated that patients receiving topical St. John's Wort oil will demonstrate significantly lower periorbital edema and ecchymosis scores compared to the control group during the early postoperative period.
Conclusion
Given the role of soft tissue hemorrhage in the development of postoperative ecchymosis and edema, and considering the documented pharmacological properties of St. John's Wort, topical application may represent a safe and effective adjunctive intervention for reducing periorbital complications following rhinoplasty. Further clinical evidence may support its integration into routine postoperative care protocols.
Aim of the Study
The aim of this study is to investigate the effect of St. John's Wort oil (Hypericum perforatum) on postoperative periorbital edema and ecchymosis in patients undergoing rhinoplasty.
Hypotheses
H0a (Null Hypothesis):
St. John's Wort oil (Hypericum perforatum) has no effect on postoperative periorbital edema following rhinoplasty.
H1a (Alternative Hypothesis):
St. John's Wort oil (Hypericum perforatum) has a significant effect on postoperative periorbital edema following rhinoplasty.
H0b (Null Hypothesis):
St. John's Wort oil (Hypericum perforatum) has no effect on postoperative periorbital ecchymosis following rhinoplasty.
H1b (Alternative Hypothesis):
St. John's Wort oil (Hypericum perforatum) has a significant effect on postoperative periorbital ecchymosis following rhinoplasty.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Topical St. John's Wort oil applicationPatients undergoing rhinoplasty will provide verbal and written consent, and the experimental group will undergo a preoperative patch test for St. John's Wort oil (Hypericum perforatum) allergy. Postoperatively, patients will receive routine cold application followed by bilateral topical St. John's Wort oil. On the day of surgery, three applications will be administered at 4-hour intervals, continuing three times daily for seven days at home. Periorbital edema and ecchymosis will be assessed at 1 and 24 hours postoperatively through direct observation, and on Days 3 and 7 via digital photographs. Both the researcher and clinical nurse will independently score each eye using standardized criteria. Data will be analyzed to evaluate the effect of St. John's Wort oil on postoperative periorbital complications. |
| Control group | No intervention | –During the preoperative period, patients will be introduced to the study, provided with detailed information, and both verbal and written informed consent will be obtained. After introducing the data collection tools, the researcher will complete the Personal Information Data Form. Postoperatively (considered Day 0), periorbital edema and ecchymosis scores will be recorded at four time points: 1 hour, 24 hours (Day 1), 72 hours (Day 3), and 168 hours (Day 7) using the Upper and Lower Eyelid Ecchymosis Assessment Scale and the Eyelid Edema Assessment Scale. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Undergoing aesthetic or functional rhinoplasty. Aged 18 years or older. Not receiving anticoagulant therapy. No known hematological disorders. No fibrinolytic disorders. No allergy to St. John's Wort oil (Hypericum perforatum) or any of its components.
- Undergoing surgery with the same surgical technique. No communication difficulties. No psychiatric diagnoses. First-time rhinoplasty patients.
Key exclusion criteria (3 listed)
- Undergoing rhinoplasty due to trauma. Diagnosed with diabetes mellitus. Diagnosed with hypertension. Current smokers. Having a psychiatric diagnosis. Allergic to St. John's Wort oil (Hypericum perforatum) or any of its components.
- Using anticoagulant therapy. Having hematological disorders. Having fibrinolytic disorders. Using medications metabolized by CYP3A4, CYP2C9, or CYP2C19. Using medications containing oral contraceptives, antidepressants, or theophylline.
- Scheduled for organ transplantation within the next two months.
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 |
|---|---|---|
| Topical St. John's Wort oil applicationConsidering the beneficial effects of St. John's Wort oil, the study aims to accelerate patients' return to normal daily activities after surgery by more rapidly reducing aesthetic concerns and postoperative complications. | Other | Experimental group |
Primary outcome
Periorbital edema and ecchymosis score
Time frame: Within the first week after surgery
Periorbital edema and ecchymosis score: A standardized clinical scale used to quantify the severity of swelling (edema) and bruising (ecchymosis) around the upper and lower eyelids following surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Individual participant dataSharing planned: Yes. Effect of postoperative topical St. John's Wort oil (Hypericum perforatum) on periorbital edema and ecchymosis following rhinoplasty
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Topical St. John's Wort oil application in people with Effect of Postoperative Topical St. John's Wort Oil (Hypericum Perforatum) on Periorbital Edema and Ecchymosis Following Rhinoplasty, run by Inonu 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 3 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: under way, not looking for participants, as of the sponsor's last update on 4 Mar 2026. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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 edema and ecchymosis score (time frame: Within the first week after surgery). 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 4 Mar 2026.