Ignite Creation Date:
2025-12-24 @ 5:13 PM
Ignite Modification Date:
2026-01-03 @ 6:51 PM
Study NCT ID:
NCT07003750
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-04
First Post:
2025-05-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Surgical Wound Infection Prevention Bundle in Patients Undergoing Coronary Bypass Graft Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-26', 'studyFirstSubmitDate': '2025-05-08', 'studyFirstSubmitQcDate': '2025-05-26', 'lastUpdatePostDateStruct': {'date': '2025-06-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'surgical site wound infection', 'timeFrame': 'From enrollment to 6 months after surgery', 'description': 'Early complications including superficial and deep surgical site infection. Late complications including DSWI, systemic and chronic sinus'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Infection Due to Coronary Artery Bypass Graft (Diagnosis)']}, 'descriptionModule': {'briefSummary': 'estimate the utilization of locally customized surgical wound infection bundle to prevent and or control of infection in patients undergoing CABG surgery in Sohag'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* coronary artery disease ,diebetes mellitus,hypertension,\n\nExclusion Criteria:\n\n* patients who have cancer , immunocompromised patients, cardiac surgeries other than CABG'}, 'identificationModule': {'nctId': 'NCT07003750', 'briefTitle': 'Surgical Wound Infection Prevention Bundle in Patients Undergoing Coronary Bypass Graft Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Surgical Wound Infection Prevention Bundle in Patients Undergoing Coronary Bypass Graft Surgery Sohag Experience', 'orgStudyIdInfo': {'id': 'soh-Med--25-4-05MS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'group 1', 'description': '* Preoperative:\n\n 1. Nightly CHG baths\n 2. Mupirocin nasal ointment twice daily for 2 to 5 days prior to surgery\n 3. Hair removal with clippers\n* Intraoperative:\n\n 1. Skin antisepsis with CHG solution\n 2. Standardized IV antibiotic doses at the following time points :within 5 to 60 minutes of the initial surgical incision, with initiation of cardiopulmonary bypass ,and every 3 hours intraoperatively for the duration of the case.\n* Postoperative :\n\n 1. The occlusive sternal dressing applied at time of chest closure and removed 48 hours postoperatively then daily dressing thereafter.\n 2. Daily postoperative linen change and minimize sternotomy exposure to home blankets', 'interventionNames': ['Other: Surgical wound infection prevention bundle']}, {'type': 'NO_INTERVENTION', 'label': 'group 2', 'description': '* Preoperative:\n\n 1. Preoperative water and soap bath\n 2. Hair removal with razor\n* Intraoperative:\n\n 1. Skin antisepsis with betadine solution\n 2. One dose of antibiotic just before skin incision\n* Postoperative:\n\n 1. The occlusive sternal dressing removed 72 hours postoperatively then daily dressing\n 2. No specific concerns about linens change and home blankets exposure'}], 'interventions': [{'name': 'Surgical wound infection prevention bundle', 'type': 'OTHER', 'description': 'utilization of locally customized surgical wound infection bundle to prevent and or control of infection in patients undergoing CABG surgery', 'armGroupLabels': ['group 1']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'mohamed ragab hassane, MBBCH', 'role': 'CONTACT', 'email': 'mohassane308@gmail.com', 'phone': '00201080170156'}, {'name': 'Mohsen Saber Ahmed, MD', 'role': 'CONTACT', 'email': 'mohsensaber@med.sohag.edu.eg', 'phone': '0020 1014678086'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'cardiothoracic surgery resident', 'investigatorFullName': 'Mohamed Ragab Mostafa', 'investigatorAffiliation': 'Sohag University'}}}}