Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2025-12-24 @ 5:53 PM
Study NCT ID:
NCT06651268
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-10-28
First Post:
2024-10-18
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness of Topical Vancomycin in Reducing Sternal Wound Infections Post-Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-11-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-24', 'studyFirstSubmitDate': '2024-10-18', 'studyFirstSubmitQcDate': '2024-10-18', 'lastUpdatePostDateStruct': {'date': '2024-10-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of sternal wound infections (SWIs) following cardiac surgery', 'timeFrame': 'he patients will be evaluated at three key time points: 48 hours post-surgery 7 days post-surgery 1 month post-surgery', 'description': 'Incidence of sternal wound infections (SWIs) following cardiac surgery in patients who receive vancomycin powder application compared to those who do not. The infections would be diagnosed based on clinical signs such as redness, pain, swelling, and purulent discharge at the wound site.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Wound Complication', 'Cardiac Surgery']}, 'descriptionModule': {'briefSummary': 'Title: The Role of Vancomycin Powder in Reducing Sternal Wound Infections Following Cardiac Surgery: A Randomized Controlled Trial\n\nIntroduction:\n\nSternal wound infections (SWIs) are significant complications in cardiac surgery, leading to serious issues like mediastinitis, prolonged hospital stays, and higher healthcare costs. This study explores the potential of topical vancomycin powder to reduce SWIs when added to the standard use of systemic antibiotics.\n\nObjectives:\n\nTo assess the effectiveness of vancomycin powder in preventing SWIs post-cardiac surgery.\n\nTo determine its impact on postoperative hospital stays.\n\nStudy Design and Methodology:\n\nA randomized controlled trial will be conducted at Liaquat National Hospital, Karachi, with 24 patients (12 in each group).\n\nGroup A will receive standard wound closure, while Group B will receive vancomycin powder applied to the sternal wound.\n\nPostoperative wound assessments will be conducted at 48 hours, 7 days, and 1 month.\n\nEthical Considerations:\n\nEthical approval will be obtained, and informed consent will be sought from all participants', 'detailedDescription': 'The sternotomy approach is widely used in cardiac surgeries, making sternal wound infections a significant concern. These infections can lead to serious complications, including sepsis, reoperation, and increased healthcare costs. Systemic antibiotic prophylaxis is a common practice, but local antibiotic application at the surgical site could further reduce the risk of infection. Vancomycin, due to its effectiveness against gram-positive bacteria, is an ideal candidate for local application. Previous studies in orthopedic surgeries have demonstrated reduced infection rates with vancomycin powder, but its efficacy in cardiac surgery has not been thoroughly explored. This study aims to investigate whether local application of vancomycin powder reduces the incidence of sternal wound infections after cardiac surgery compared to standard care. Additionally, it will evaluate secondary outcomes such as hospital stay duration, postoperative morbidity, and wound-related complications, including dehiscence and the need for reoperation.\n\nThe study will be a randomized controlled trial conducted at Liaquat National Hospital, Karachi, Pakistan. A total of 24 patients undergoing cardiac surgery will be randomly allocated to either a control group (standard closure technique) or an intervention group (1 gram of vancomycin powder applied locally before sternal closure). Both groups will receive systemic antibiotic prophylaxis as part of routine care.\n\nThis study aims to provide evidence on the efficacy of local vancomycin powder application in reducing sternal wound infections after cardiac surgery. If successful, it could offer a simple, cost-effective intervention to improve postoperative outcomes in cardiac surgery patients. Further research may be needed to validate the findings and support its widespread implementation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* .Patients aged between 21 and 80 years were included in the study.\n* Both male and female participants were eligible.\n* Patients undergoing various adult cardiac surgical procedures, including coronary artery bypass grafting (CABG), atrial septal defect (ASD) repair, ventricular septal defect (VSD) repair, and valve replacement, were considered for inclusion.\n\nExclusion Criteria:\n\n* Patients who did not provide informed consent were excluded from the study.\n* Individuals with a known sensitivity to vancomycin were not eligible.\n* Pediatric patients were excluded.\n* Patients undergoing redo surgeries were also excluded from participation'}, 'identificationModule': {'nctId': 'NCT06651268', 'briefTitle': 'Effectiveness of Topical Vancomycin in Reducing Sternal Wound Infections Post-Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Liaquat National Hospital & Medical College'}, 'officialTitle': 'Local Application of Vancomycin (powder) Before Surgical Closure Helps to Reduce Sternal Wound Infection After Cardiac Surgery Procedures.', 'orgStudyIdInfo': {'id': 'LNH-2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'while Group B (vancomycin group, n=12) had vancomycin powder applied during closure. T', 'interventionNames': ['Drug: while Group B (vancomycin group, n=12) had vancomycin powder applied during closure. T']}, {'type': 'OTHER', 'label': ': Group A (control, n=12) received standard closure techniques without vancomycin powder', 'description': 'Group A (control, n=12) received standard closure techniques without vancomycin powder', 'interventionNames': ['Drug: while Group B (vancomycin group, n=12) had vancomycin powder applied during closure. T']}], 'interventions': [{'name': 'while Group B (vancomycin group, n=12) had vancomycin powder applied during closure. T', 'type': 'DRUG', 'description': 'while Group B (vancomycin group, n=12) had vancomycin powder applied during closure. T', 'armGroupLabels': [': Group A (control, n=12) received standard closure techniques without vancomycin powder', 'while Group B (vancomycin group, n=12) had vancomycin powder applied during closure. T']}]}, 'contactsLocationsModule': {'locations': [{'zip': '74201', 'city': 'Karachi', 'state': 'Sindh', 'country': 'Pakistan', 'contacts': [{'name': 'Qaisar Aziz Dr, FCPS', 'role': 'CONTACT', 'email': 'qaiserazizdr@hotmail.com', 'phone': '+923362405480'}], 'facility': 'Cardiac Surgery', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}], 'centralContacts': [{'name': 'Qaiser Aziz qaiserazizdr@hotmail.com, FCPS', 'role': 'CONTACT', 'email': 'qaiserazizdr@hotmail.com', 'phone': '+923362405480'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Due to privacy issue'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Liaquat National Hospital & Medical College', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Cardiac Surgery', 'investigatorFullName': 'Qaiser Aziz', 'investigatorAffiliation': 'Liaquat National Hospital & Medical College'}}}}