THE EFFECT OF ST. JOHN'S WORT OİL APPLİCATİON ON PERIORBITAL EDEMA AND ECCHYMOSİS AFTER RHİNOPLASTY
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Periorbital edema and ecchymosis score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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 CYP2C
- •Using medications containing oral contraceptives, antidepressants, or theophylline.
- •Scheduled for organ transplantation within the next two months.
研究组 & 干预措施
Experimental group
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.
干预措施: Topical St. John's Wort oil application (Other)
Control group
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.
结局指标
主要结局
Periorbital edema and ecchymosis score
时间窗: 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.
次要结局
未报告次要终点
研究者
Şirin URUÇ DEMİR
PhD student
Inonu University