Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2026-02-21 @ 9:48 PM
Study NCT ID:
NCT01700803
Status:
COMPLETED
Last Update Posted:
2012-10-04
First Post:
2012-10-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Povidone Iodine and Cesarean Section Wound Infections
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014946', 'term': 'Wound Infection'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011206', 'term': 'Povidone-Iodine'}], 'ancestors': [{'id': 'D007466', 'term': 'Iodophors'}, {'id': 'D017613', 'term': 'Iodine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D011145', 'term': 'Polyvinyls'}, {'id': 'D014753', 'term': 'Vinyl Compounds'}, {'id': 'D000475', 'term': 'Alkenes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011205', 'term': 'Povidone'}, {'id': 'D011760', 'term': 'Pyrrolidinones'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010969', 'term': 'Plastics'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3231}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-10-03', 'studyFirstSubmitDate': '2012-10-03', 'studyFirstSubmitQcDate': '2012-10-03', 'lastUpdatePostDateStruct': {'date': '2012-10-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The difference of incidence of surgical site infection between both groups', 'timeFrame': '4 month', 'description': 'Determine the difference in incidence of surgical site infection between Povidone Iodine 10% versus 7.5% hand scrub'}], 'secondaryOutcomes': [{'measure': 'The difference in the side effects between both groups e.g. dermatitis', 'timeFrame': '4 month', 'description': 'Determine the difference in incidence of side effects between Povidone Iodine 10% versus 7.5% hand scrub'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Betadine', 'Povidine Iodine', 'Hand scrubbing', 'Cesarean section wound infections', 'post cesarean section'], 'conditions': ['Wound Infections']}, 'descriptionModule': {'briefSummary': 'The aim of this randomized clinical trial is to compare the efficiency of hand scrubbing by Povidone-Iodine solution 10% over 7.5% concentration in decreasing post-cesarean section wound infections \\& compare side effects of both agents.', 'detailedDescription': 'For centuries, hand washing with soap and water has been considered the main approach for personal hygiene. In the community, hand hygiene has been known to prevent infectious diseases and to decrease the burden of disease. Currently, hand hygiene is considered the most important measure for preventing the spread of pathogens in health-care settings.\n\nThere are multiple agents used for surgical hand scrubbing as alcohol, chlorhexidine, iodine/iodophors, para-chloro-meta-xylenol \\& triclosan. Ideally, the optimum antiseptic used for scrub should have broad spectrum of activity, persistent effect \\& fast acting. Unfortunately most studies evaluating surgical scrub antiseptics have focused on measuring hand bacterial colony counts. No randomized clinical trials have evaluated the impact of surgical scrub choice on surgical site infection risk \\& proven its efficiency.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* elective caesarian section (CS)\n\nExclusion Criteria:\n\n* diabetes,\n* immuno-compromised patients'}, 'identificationModule': {'nctId': 'NCT01700803', 'briefTitle': 'Povidone Iodine and Cesarean Section Wound Infections', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Povidone Iodine 10% Versus 7.5% Hand Scrub and Cesarean Section Wound Infections: A Randomized Trial', 'orgStudyIdInfo': {'id': 'Betadine CS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Povidone Iodine 10%', 'description': 'Using Povidone Iodine 10% hand scrub before caesarian section', 'interventionNames': ['Drug: Povidone Iodine 10% vand cesarean section wound infections']}, {'type': 'EXPERIMENTAL', 'label': 'Povidone Iodine 7.5% hand scrub', 'description': 'Using Povidone Iodine 7.5% hand scrub before caesarian section', 'interventionNames': ['Drug: Povidone Iodine 7.5% vand cesarean section wound infections']}], 'interventions': [{'name': 'Povidone Iodine 10% vand cesarean section wound infections', 'type': 'DRUG', 'armGroupLabels': ['Povidone Iodine 10%']}, {'name': 'Povidone Iodine 7.5% vand cesarean section wound infections', 'type': 'DRUG', 'armGroupLabels': ['Povidone Iodine 7.5% hand scrub']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71111', 'city': 'Asyut', 'country': 'Egypt', 'facility': 'Women Health Hospital - Assiut university', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mohammed Khairy Ali', 'investigatorAffiliation': 'Assiut University'}}}}