Inonu Universty
Malatya, 44100, Turkey (Türkiye)
NCT Number: NCT07448051
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.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Not applicable
Malatya, 44100, Turkey (Türkiye)
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Undergoing surgery with the same surgical technique. No communication difficulties. No psychiatric diagnoses. First-time rhinoplasty patients.
Exclusion criteria
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.
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.
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.
Inonu University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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