Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 10:44 AM
Study NCT ID:
NCT07448051
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-03-04
First Post:
2026-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
THE EFFECT OF ST. JOHN'S WORT OİL APPLİCATİON ON PERIORBITAL EDEMA AND ECCHYMOSİS AFTER RHİNOPLASTY
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004438', 'term': 'Ecchymosis'}, {'id': 'D004487', 'term': 'Edema'}], 'ancestors': [{'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 110}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-07-27', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-26', 'studyFirstSubmitDate': '2026-02-26', 'studyFirstSubmitQcDate': '2026-02-26', 'lastUpdatePostDateStruct': {'date': '2026-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Periorbital edema and ecchymosis score', 'timeFrame': 'Within the first week after surgery', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Rhinoplasti, Ecchymosis, Edema'], 'conditions': ["Effect of Postoperative Topical St. John's Wort Oil (Hypericum Perforatum) on Periorbital Edema and Ecchymosis Following Rhinoplasty"]}, 'descriptionModule': {'briefSummary': "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.\n\nMethods\n\nThis 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.\n\nResults\n\nIt 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.\n\nConclusion\n\nGiven 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.\n\nAim of the Study\n\nThe 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.\n\nHypotheses\n\nH0a (Null Hypothesis):\n\nSt. John's Wort oil (Hypericum perforatum) has no effect on postoperative periorbital edema following rhinoplasty.\n\nH1a (Alternative Hypothesis):\n\nSt. John's Wort oil (Hypericum perforatum) has a significant effect on postoperative periorbital edema following rhinoplasty.\n\nH0b (Null Hypothesis):\n\nSt. John's Wort oil (Hypericum perforatum) has no effect on postoperative periorbital ecchymosis following rhinoplasty.\n\nH1b (Alternative Hypothesis):\n\nSt. John's Wort oil (Hypericum perforatum) has a significant effect on postoperative periorbital ecchymosis following rhinoplasty."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 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.\n\nUndergoing surgery with the same surgical technique. No communication difficulties. No psychiatric diagnoses. First-time rhinoplasty patients.\n\nExclusion Criteria:\n\n* 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.\n\nUsing anticoagulant therapy. Having hematological disorders. Having fibrinolytic disorders. Using medications metabolized by CYP3A4, CYP2C9, or CYP2C19. Using medications containing oral contraceptives, antidepressants, or theophylline.\n\nScheduled for organ transplantation within the next two months."}, 'identificationModule': {'nctId': 'NCT07448051', 'briefTitle': "THE EFFECT OF ST. JOHN'S WORT OİL APPLİCATİON ON PERIORBITAL EDEMA AND ECCHYMOSİS AFTER RHİNOPLASTY", 'organization': {'class': 'OTHER', 'fullName': 'Inonu University'}, 'officialTitle': "THE EFFECT OF ST. JOHN'S WORT OİL APPLİCATİON ON PERIORBITAL EDEMA AND ECCHYMOSİS AFTER RHİNOPLASTY", 'orgStudyIdInfo': {'id': '2024/6259'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': "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.\n\nPeriorbital 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.", 'interventionNames': ["Other: Topical St. John's Wort oil application"]}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': '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.'}], 'interventions': [{'name': "Topical St. John's Wort oil application", 'type': 'OTHER', 'description': "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.", 'armGroupLabels': ['Experimental group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44100', 'city': 'Malatya', 'state': 'Malatya', 'country': 'Turkey (Türkiye)', 'facility': 'Inonu Universty', 'geoPoint': {'lat': 38.35018, 'lon': 38.31667}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'ipdSharing': 'YES', 'description': "Effect of postoperative topical St. John's Wort oil (Hypericum perforatum) on periorbital edema and ecchymosis following rhinoplasty"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Inonu University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD student', 'investigatorFullName': 'Şirin URUÇ DEMİR', 'investigatorAffiliation': 'Inonu University'}}}}