Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2026-02-21 @ 8:27 AM
Study NCT ID:
NCT00467857
Status:
COMPLETED
Last Update Posted:
2012-09-18
First Post:
2007-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of the Combination of a Cyanoacrylate and Surgical Solutions in Reducing Skin Flora Contamination
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Shu-Ping.Yang@kcc.com', 'phone': '770-587-7267', 'title': 'Dr. Shu-Ping Yang', 'organization': 'Kimberly-Clark Health Care'}, 'certainAgreement': {'otherDetails': 'All publications and presentations resulting from this multi-center trial sponsored by Kimberly-Clark must be approved by all investigators and the sponsor.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '30 days', 'description': 'Investigators assessed patients for the occurrence of adverse events at each study visit and recorded in case report form. Device-related adverse events, surgical site infections, and death were the only types of adverse events collected.', 'eventGroups': [{'id': 'EG000', 'title': 'InteguSeal* and Standard Surgical Preparation Solutions', 'description': 'Prior to incision, surgical sites were prepared using InteguSeal\\* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal\\* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.', 'otherNumAtRisk': 146, 'otherNumAffected': 6, 'seriousNumAtRisk': 146, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': 'Standard Surgical Preparation Solutions', 'description': 'Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.', 'otherNumAtRisk': 147, 'otherNumAffected': 10, 'seriousNumAtRisk': 147, 'seriousNumAffected': 8}], 'otherEvents': [{'term': 'Arteriovenous graft site infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Incision site infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Mediastinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Postoperative wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Skin graft infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}], 'seriousEvents': [{'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Sudden death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Incision site infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Mediastinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Hospitalisation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}], 'frequencyThreshold': '0.5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Number of Unique Bacterial Isolates From Pre-skin Preparation to Post-CABG - Sternal Site', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'InteguSeal* and Standard Surgical Preparation Solutions', 'description': 'Prior to incision, surgical sites were prepared using InteguSeal\\* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal\\* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.'}, {'id': 'OG001', 'title': 'Standard Surgical Preparation Solutions', 'description': 'Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.34', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '-1.31', 'spread': '1.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.655', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'The sample size determination was selected to achieve 80% power to detect an absolute 10% difference between the two treatment groups in proportion of qualitative reduction in representative skin flora, at a significance level (alpha) of 0.05 using a two-sided z-test with continuity correction.', 'statisticalMethod': 'Wilcoxon-Rank Sum Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Before surgery (prior to skin preparation) and after surgery (after closing fascia)', 'description': 'Number of unique bacterial colony types isolated from samples of skin flora taken from the sternal incision site after surgery minus before surgery (prior to skin prep). Unique colonies were determined based on Gram stain, colony morphology, catalase, coagulase, or staphylococci latex agglutination and oxidase tests.', 'unitOfMeasure': 'isolates', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol'}, {'type': 'SECONDARY', 'title': 'Change in Bacterial Count From Pre-skin Preparation to Post-CABG - Sternal Site', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'InteguSeal* and Standard Surgical Preparation Solutions', 'description': 'Prior to incision, surgical sites were prepared using InteguSeal\\* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal\\* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.'}, {'id': 'OG001', 'title': 'Standard Surgical Preparation Solutions', 'description': 'Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.14', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '-1.99', 'spread': '1.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.276', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon-Rank Sum Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Before surgery (prior to skin preparation) and after surgery (after closing fascia)', 'description': 'Total bacterial counts from samples of skin flora from the sternal incision site after surgery minus before surgery (prior to skin prep).', 'unitOfMeasure': 'log CFU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol'}, {'type': 'SECONDARY', 'title': 'Change in Bacterial Count From Pre-skin Preparation to Post-CABG - Graft Site', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'InteguSeal* and Standard Surgical Preparation Solutions', 'description': 'Prior to incision, surgical sites were prepared using InteguSeal\\* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal\\* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.'}, {'id': 'OG001', 'title': 'Standard Surgical Preparation Solutions', 'description': 'Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.42', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '-2.31', 'spread': '1.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.375', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon-Rank Sum Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Before surgery (prior to skin preparation) and after surgery (after closing fascia)', 'description': 'Total bacterial counts from samples of skin flora from the graft incision site after surgery minus before surgery (prior to skin prep).', 'unitOfMeasure': 'log CFU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol'}, {'type': 'SECONDARY', 'title': 'Post-CABG Procedure Bacterial Count - Sternal Site', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'InteguSeal* and Standard Surgical Preparation Solutions', 'description': 'Prior to incision, surgical sites were prepared using InteguSeal\\* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal\\* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.'}, {'id': 'OG001', 'title': 'Standard Surgical Preparation Solutions', 'description': 'Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.58', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '0.83', 'spread': '1.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.039', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon-Rank Sum Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Post-surgery', 'description': 'Total bacterial counts from samples of skin flora of the sternal incision site taken immediately following the CABG procedure.', 'unitOfMeasure': 'log CFU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol'}, {'type': 'SECONDARY', 'title': 'Post-CABG Procedure Bacterial Count - Graft Site', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'InteguSeal* and Standard Surgical Preparation Solutions', 'description': 'Prior to incision, surgical sites were prepared using InteguSeal\\* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal\\* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.'}, {'id': 'OG001', 'title': 'Standard Surgical Preparation Solutions', 'description': 'Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.19', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '0.34', 'spread': '0.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.057', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon-Rank Sum Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Post-surgery', 'description': 'Total bacterial counts from samples of skin flora of the graft incision site taken immediately following the CABG procedure.', 'unitOfMeasure': 'log CFU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol'}, {'type': 'SECONDARY', 'title': 'Change in the Number of Unique Bacterial Isolates From Pre-skin Preparation to Post-incision - Sternal Site', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'InteguSeal* and Standard Surgical Preparation Solutions', 'description': 'Prior to incision, surgical sites were prepared using InteguSeal\\* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal\\* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.'}, {'id': 'OG001', 'title': 'Standard Surgical Preparation Solutions', 'description': 'Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.53', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '-1.59', 'spread': '1.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.646', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon-Rank Sum Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Before surgery (prior to skin preparation) and immediately after incision', 'description': 'Number of unique bacterial colony types isolated from samples of skin flora from the sternal incision site immediately after the incision minus before surgery (prior to surgical skin prep). Unique colonies were determined based on Gram stain, colony morphology, catalase, coagulase, or staphylococci latex agglutination and oxidase tests.', 'unitOfMeasure': 'isolates', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol'}, {'type': 'SECONDARY', 'title': 'Change in the Number of Unique Bacterial Isolates From Pre-skin Preparation to Post-incision - Graft Site', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'InteguSeal* and Standard Surgical Preparation Solutions', 'description': 'Prior to incision, surgical sites were prepared using InteguSeal\\* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal\\* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.'}, {'id': 'OG001', 'title': 'Standard Surgical Preparation Solutions', 'description': 'Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.95', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '-1.98', 'spread': '1.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.788', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon-Rank Sum Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Before surgery (prior to skin preparation) and immediately after incision', 'description': 'Number of unique bacterial colony types isolated from samples of skin flora from the graft incision site immediately after the incision minus before surgery (prior to surgical skin prep). Unique colonies were determined based on Gram stain, colony morphology, catalase, coagulase, or staphylococci latex agglutination and oxidase tests.', 'unitOfMeasure': 'isolates', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol'}, {'type': 'SECONDARY', 'title': 'Change in Bacterial Count From Pre-skin Preparation to Post-incision - Sternal Site', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'InteguSeal* and Standard Surgical Preparation Solutions', 'description': 'Prior to incision, surgical sites were prepared using InteguSeal\\* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal\\* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.'}, {'id': 'OG001', 'title': 'Standard Surgical Preparation Solutions', 'description': 'Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.51', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '-2.54', 'spread': '1.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.960', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon-Rank Sum Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Before surgery (prior to skin preparation) and immediately after incision', 'description': 'Total bacterial counts from samples of skin flora from the sternal incision site immediately after incision minus before surgery (prior to skin prep)', 'unitOfMeasure': 'log CFU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol'}, {'type': 'PRIMARY', 'title': 'Change in Number of Unique Bacterial Isolates From Pre-skin Preparation to Post-CABG - Graft Site', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'InteguSeal* and Standard Surgical Preparation Solutions', 'description': 'Prior to incision, surgical sites were prepared using InteguSeal\\* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal\\* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.'}, {'id': 'OG001', 'title': 'Standard Surgical Preparation Solutions', 'description': 'Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.88', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '-1.75', 'spread': '1.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.359', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'The sample size determination was selected to achieve 80% power to detect an absolute 10% difference between the two treatment groups in proportion of qualitative reduction in representative skin flora, at a significance level (alpha) of 0.05 using a two-sided z-test with continuity correction.', 'statisticalMethod': 'Wilcoxon-Rank Sum Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Before surgery (prior to skin preparation) and after surgery (after closing fascia)', 'description': 'Number of unique bacterial colony types isolated from samples of skin flora taken from the graft incision site after surgery minus before surgery (prior to skin prep). Unique colonies were determined based on Gram stain, colony morphology, catalase, coagulase, or staphylococci latex agglutination and oxidase tests.', 'unitOfMeasure': 'isolates', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol'}, {'type': 'SECONDARY', 'title': 'Change in Bacterial Count From Pre-skin Preparation to Post-incision - Graft Site', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'InteguSeal* and Standard Surgical Preparation Solutions', 'description': 'Prior to incision, surgical sites were prepared using InteguSeal\\* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal\\* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.'}, {'id': 'OG001', 'title': 'Standard Surgical Preparation Solutions', 'description': 'Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.51', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '-2.58', 'spread': '1.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.730', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon-Rank Sum Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Before surgery (prior to skin preparation) and immediately after incision', 'description': 'Total bacterial counts from samples of skin flora from the graft incision site immediately after incision minus before surgery (prior to skin prep)', 'unitOfMeasure': 'log CFU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol'}, {'type': 'SECONDARY', 'title': 'Post-incision Bacterial Count - Sternal Site', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'InteguSeal* and Standard Surgical Preparation Solutions', 'description': 'Prior to incision, surgical sites were prepared using InteguSeal\\* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal\\* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.'}, {'id': 'OG001', 'title': 'Standard Surgical Preparation Solutions', 'description': 'Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.21', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '0.26', 'spread': '0.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.348', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon-Rank Sum Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Immediately after surgical incision', 'description': 'Total bacterial counts from samples of skin flora of the sternal incision site taken immediately following the surgical incision', 'unitOfMeasure': 'log CFU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol'}, {'type': 'SECONDARY', 'title': 'Post-incision Bacterial Count - Graft Site', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'InteguSeal* and Standard Surgical Preparation Solutions', 'description': 'Prior to incision, surgical sites were prepared using InteguSeal\\* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal\\* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.'}, {'id': 'OG001', 'title': 'Standard Surgical Preparation Solutions', 'description': 'Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.10', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '0.08', 'spread': '0.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.512', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon-Rank Sum Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Immediately after surgical incision', 'description': 'Total bacterial counts from samples of skin flora of the graft incision site taken immediately following the surgical incision', 'unitOfMeasure': 'log CFU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol'}, {'type': 'SECONDARY', 'title': 'Number of Patients With SSI at the Sternal Site and/or Graft Site', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'InteguSeal* and Standard Surgical Preparation Solutions', 'description': 'Prior to incision, surgical sites were prepared using InteguSeal\\* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal\\* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.'}, {'id': 'OG001', 'title': 'Standard Surgical Preparation Solutions', 'description': 'Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.285', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '30 days', 'description': 'Number of patients who develop at least one surgical site infection at the sternal or graft site during the 30 day post-op follow-up period', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Alcohol Use, Tobacco Use, or Obesity With Surgical Site Infection (SSI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'InteguSeal* and Standard Surgical Preparation Solutions', 'description': 'Prior to incision, surgical sites were prepared using InteguSeal\\* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal\\* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.'}, {'id': 'OG001', 'title': 'Standard Surgical Preparation Solutions', 'description': 'Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.024', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '30 days', 'description': 'Number of patients with risk factors of alcohol use, tobacco use, or obesity who developed an SSI at the sternal and/or graft site', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subset of Intention to treat participants with alcohol use, tobacco use, or obesity'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'InteguSeal* and Standard Surgical Preparation Solutions', 'description': 'Prior to incision, surgical sites were prepared using InteguSeal\\* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal\\* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.'}, {'id': 'FG001', 'title': 'Standard Surgical Preparation Solutions', 'description': 'Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '146'}, {'groupId': 'FG001', 'numSubjects': '147'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '143'}, {'groupId': 'FG001', 'numSubjects': '139'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrew consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Discharged from court service', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Emergency care required', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Did not meet inclusion/exclusion criteri', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Discontinuation reason missing', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'Patients were enrolled between April 2006 and February 2009 at 5 centers in the United States, Europe, Asia, and Latin America.', 'preAssignmentDetails': 'Of 300 patients assessed for eligibility, 7 were not allocated to treatment due to inclusion or exclusion criteria.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'BG000'}, {'value': '147', 'groupId': 'BG001'}, {'value': '293', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'InteguSeal* and Standard Surgical Preparation Solutions', 'description': 'Prior to incision, surgical sites were prepared using InteguSeal\\* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal\\* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.'}, {'id': 'BG001', 'title': 'Standard Surgical Preparation Solutions', 'description': 'Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.18', 'spread': '8.53', 'groupId': 'BG000'}, {'value': '62.94', 'spread': '9.97', 'groupId': 'BG001'}, {'value': '63.06', 'spread': '9.28', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '120', 'groupId': 'BG000'}, {'value': '129', 'groupId': 'BG001'}, {'value': '249', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '1.67', 'spread': '0.10', 'groupId': 'BG000'}, {'value': '1.66', 'spread': '0.09', 'groupId': 'BG001'}, {'value': '1.67', 'spread': '0.10', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Data for n=145 microbial skin sealant, n=147 control', 'unitOfMeasure': 'meters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '76.2', 'spread': '14.4', 'groupId': 'BG000'}, {'value': '73.8', 'spread': '12.0', 'groupId': 'BG001'}, {'value': '75.0', 'spread': '13.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilograms', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '27.3', 'spread': '4.0', 'groupId': 'BG000'}, {'value': '26.6', 'spread': '3.4', 'groupId': 'BG001'}, {'value': '26.9', 'spread': '3.71', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Results for n=145 microbial skin sealant, n=147 control.', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Obesity', 'classes': [{'title': 'Obese (BMI>30.0 kg/m^2)', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}, {'title': 'Not obese', 'categories': [{'measurements': [{'value': '106', 'groupId': 'BG000'}, {'value': '127', 'groupId': 'BG001'}, {'value': '233', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Diabetes mellitus, type 1 or 2', 'classes': [{'title': 'present', 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}]}, {'title': 'absent', 'categories': [{'measurements': [{'value': '97', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '195', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Tobacco Use', 'classes': [{'title': 'yes', 'categories': [{'measurements': [{'value': '84', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '175', 'groupId': 'BG002'}]}]}, {'title': 'no', 'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Alcohol Use', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '104', 'groupId': 'BG000'}, {'value': '95', 'groupId': 'BG001'}, {'value': '199', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'New York Heart Association (NYHA) Functional Classification', 'classes': [{'title': 'Class I', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}]}, {'title': 'Class II', 'categories': [{'measurements': [{'value': '73', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '134', 'groupId': 'BG002'}]}]}, {'title': 'Class III', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}]}, {'title': 'Class IV', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'The NYHA Functional Classification provides a simple way of classifying the extent of heart failure. It places patients in one of four categories based on how much they are limited during physical activity:\n\nClass I: No symptoms and no limitation in ordinary physical activity.\n\nClass II: Mild symptoms and slight limitation during ordinary activity. Comfortable at rest.\n\nClass III: Marked limitation in activity due to symptoms, even during less-than-ordinary activity. Comfortable only at rest.\n\nClass IV: Severe limitations. Experiences symptoms even while at rest.', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 293}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-09-13', 'studyFirstSubmitDate': '2007-04-27', 'resultsFirstSubmitDate': '2010-11-03', 'studyFirstSubmitQcDate': '2007-04-30', 'lastUpdatePostDateStruct': {'date': '2012-09-18', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-01-17', 'studyFirstPostDateStruct': {'date': '2007-05-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-02-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Number of Unique Bacterial Isolates From Pre-skin Preparation to Post-CABG - Sternal Site', 'timeFrame': 'Before surgery (prior to skin preparation) and after surgery (after closing fascia)', 'description': 'Number of unique bacterial colony types isolated from samples of skin flora taken from the sternal incision site after surgery minus before surgery (prior to skin prep). Unique colonies were determined based on Gram stain, colony morphology, catalase, coagulase, or staphylococci latex agglutination and oxidase tests.'}, {'measure': 'Change in Number of Unique Bacterial Isolates From Pre-skin Preparation to Post-CABG - Graft Site', 'timeFrame': 'Before surgery (prior to skin preparation) and after surgery (after closing fascia)', 'description': 'Number of unique bacterial colony types isolated from samples of skin flora taken from the graft incision site after surgery minus before surgery (prior to skin prep). Unique colonies were determined based on Gram stain, colony morphology, catalase, coagulase, or staphylococci latex agglutination and oxidase tests.'}], 'secondaryOutcomes': [{'measure': 'Change in Bacterial Count From Pre-skin Preparation to Post-CABG - Sternal Site', 'timeFrame': 'Before surgery (prior to skin preparation) and after surgery (after closing fascia)', 'description': 'Total bacterial counts from samples of skin flora from the sternal incision site after surgery minus before surgery (prior to skin prep).'}, {'measure': 'Change in Bacterial Count From Pre-skin Preparation to Post-CABG - Graft Site', 'timeFrame': 'Before surgery (prior to skin preparation) and after surgery (after closing fascia)', 'description': 'Total bacterial counts from samples of skin flora from the graft incision site after surgery minus before surgery (prior to skin prep).'}, {'measure': 'Post-CABG Procedure Bacterial Count - Sternal Site', 'timeFrame': 'Post-surgery', 'description': 'Total bacterial counts from samples of skin flora of the sternal incision site taken immediately following the CABG procedure.'}, {'measure': 'Post-CABG Procedure Bacterial Count - Graft Site', 'timeFrame': 'Post-surgery', 'description': 'Total bacterial counts from samples of skin flora of the graft incision site taken immediately following the CABG procedure.'}, {'measure': 'Change in the Number of Unique Bacterial Isolates From Pre-skin Preparation to Post-incision - Sternal Site', 'timeFrame': 'Before surgery (prior to skin preparation) and immediately after incision', 'description': 'Number of unique bacterial colony types isolated from samples of skin flora from the sternal incision site immediately after the incision minus before surgery (prior to surgical skin prep). Unique colonies were determined based on Gram stain, colony morphology, catalase, coagulase, or staphylococci latex agglutination and oxidase tests.'}, {'measure': 'Change in the Number of Unique Bacterial Isolates From Pre-skin Preparation to Post-incision - Graft Site', 'timeFrame': 'Before surgery (prior to skin preparation) and immediately after incision', 'description': 'Number of unique bacterial colony types isolated from samples of skin flora from the graft incision site immediately after the incision minus before surgery (prior to surgical skin prep). Unique colonies were determined based on Gram stain, colony morphology, catalase, coagulase, or staphylococci latex agglutination and oxidase tests.'}, {'measure': 'Change in Bacterial Count From Pre-skin Preparation to Post-incision - Sternal Site', 'timeFrame': 'Before surgery (prior to skin preparation) and immediately after incision', 'description': 'Total bacterial counts from samples of skin flora from the sternal incision site immediately after incision minus before surgery (prior to skin prep)'}, {'measure': 'Change in Bacterial Count From Pre-skin Preparation to Post-incision - Graft Site', 'timeFrame': 'Before surgery (prior to skin preparation) and immediately after incision', 'description': 'Total bacterial counts from samples of skin flora from the graft incision site immediately after incision minus before surgery (prior to skin prep)'}, {'measure': 'Post-incision Bacterial Count - Sternal Site', 'timeFrame': 'Immediately after surgical incision', 'description': 'Total bacterial counts from samples of skin flora of the sternal incision site taken immediately following the surgical incision'}, {'measure': 'Post-incision Bacterial Count - Graft Site', 'timeFrame': 'Immediately after surgical incision', 'description': 'Total bacterial counts from samples of skin flora of the graft incision site taken immediately following the surgical incision'}, {'measure': 'Number of Patients With SSI at the Sternal Site and/or Graft Site', 'timeFrame': '30 days', 'description': 'Number of patients who develop at least one surgical site infection at the sternal or graft site during the 30 day post-op follow-up period'}, {'measure': 'Number of Patients With Alcohol Use, Tobacco Use, or Obesity With Surgical Site Infection (SSI)', 'timeFrame': '30 days', 'description': 'Number of patients with risk factors of alcohol use, tobacco use, or obesity who developed an SSI at the sternal and/or graft site'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cyanoacrylates', 'microbial sealants', 'skin flora contamination', 'surgery'], 'conditions': ['Skin Flora Contamination']}, 'referencesModule': {'references': [{'pmid': '16834542', 'type': 'BACKGROUND', 'citation': 'Dohmen PM. Influence of skin flora and preventive measures on surgical site infection during cardiac surgery. Surg Infect (Larchmt). 2006;7 Suppl 1:S13-7. doi: 10.1089/sur.2006.7.s1-13.'}, {'pmid': '16834544', 'type': 'BACKGROUND', 'citation': 'Malangoni MA, Cheadle WG, Dodson TF, Dohmen PM, Jones D, Katariya K, Kolvekar S, Urban JA. New opportunities for reducing risk of surgical site infection. Roundtable discussion. Surg Infect (Larchmt). 2006;7 Suppl 1:S23-39. doi: 10.1089/sur.2006.7.s1-23. No abstract available.'}, {'pmid': '16418996', 'type': 'BACKGROUND', 'citation': 'Fernandez-Ayala M, Nan DN, Farinas-Alvarez C, Revuelta JM, Gonzalez-Macias J, Farinas MC. Surgical site infection during hospitalization and after discharge in patients who have undergone cardiac surgery. Infect Control Hosp Epidemiol. 2006 Jan;27(1):85-8. doi: 10.1086/500334. Epub 2006 Jan 6.'}, {'pmid': '10196487', 'type': 'BACKGROUND', 'citation': 'Mangram AJ, Horan TC, Pearson ML, Silver LC, Jarvis WR. Guideline for Prevention of Surgical Site Infection, 1999. Centers for Disease Control and Prevention (CDC) Hospital Infection Control Practices Advisory Committee. Am J Infect Control. 1999 Apr;27(2):97-132; quiz 133-4; discussion 96.'}, {'pmid': '12362261', 'type': 'BACKGROUND', 'citation': 'Mertz PM, Davis SC, Cazzaniga AL, Drosou A, Eaglstein WH. Barrier and antibacterial properties of 2-octyl cyanoacrylate-derived wound treatment films. J Cutan Med Surg. 2003 Jan-Feb;7(1):1-6. doi: 10.1007/s10227-002-1154-6. Epub 2002 Oct 9.'}, {'pmid': '21704290', 'type': 'DERIVED', 'citation': 'von Eckardstein AS, Lim CH, Dohmen PM, Pego-Fernandes PM, Cooper WA, Oslund SG, Kelley EL. A randomized trial of a skin sealant to reduce the risk of incision contamination in cardiac surgery. Ann Thorac Surg. 2011 Aug;92(2):632-7. doi: 10.1016/j.athoracsur.2011.03.132. Epub 2011 Jun 24.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if there is a qualitative reduction in microbial skin flora post-surgery compared to pre-surgery when a cyanoacrylate based microbial sealant is used in combination with a surgical skin preparation solution.', 'detailedDescription': "The CDC states that there are two sources of surgical site infection (SSI) pathogens- endogenous and exogenous. The endogenous flora of the patient's skin, mucous membranes, or hollow viscera are the source of pathogens for most SSIs. In addition to the known sources of SSI pathogen, there are also known risk factors for SSI. The risk factors for SSIs may be patient-related, or related to the preoperative, intra-operative, and post-operative surgical treatment and care of the patient. Many known risk factors that contribute to SSIs include, but are not limited to age, nutritional status, co-morbidities, length of pre-operative stay, duration of operation, preoperative skin prep, and surgical techniques. In addition, there are certain surgical procedures in which the risks for developing SSI are greater than other surgical procedures. While there are various pre-operative and post-operative techniques or approaches to prevent these infections in patients undergoing surgeries, such as pre-operative skin care techniques, appropriate use of antibiotic prophylaxis, and the use of other post-operative anti-microbial methods, by immobilizing the patient's endogenous skin flora, an opportunity exists to reduce the rate of skin flora contamination which leads to wound contamination."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Scheduled for an elective Coronary Artery Bypass Graft (CABG) surgical procedure with median sternotomy utilizing either the saphenous vein and/or radial artery as one of the graft sites within 28 days of the screening date, as documented by a Cardiothoracic Surgeon who is the Principal Investigator or sub-investigator. This includes subjects who are also receiving internal mammary artery grafts in addition to saphenous vein and/or radial artery grafts.\n* The skin near or around the proposed incision sites should be intact.\n\nExclusion Criteria:\n\n* Known sensitivity or allergy to cyanoacrylate, isopropyl alcohol, iodine or iodine-containing products or tape allergies.\n* Female subjects that are nursing or actively lactating.\n* Abnormal skin condition adjacent to or at the surgical incision sites.\n* Hair removal at the surgical sites prior to entrance to the operating suite.\n* Use of antimicrobial impregnated incise drapes (i.e. Ioban®).\n* Hospital stay of \\>14 days immediately prior to scheduled CABG surgery.\n* Use of chemotherapy agents, within 30 days prior to Visit 1 screening.\n* Scheduled for additional chemotherapy for the duration of the study.\n* Known positive Human Immunodeficiency Virus (HIV) with a CD4 count \\< 350 mm3. If HIV status is not known, the subject is not excluded.\n* Currently taking antibiotics for an infection (within 30 days prior to Visit 1).\n* Has had therapeutic radiation to the chest within 30 days of visit 1. This does not include subjects who receive chest xrays.\n* Pre-operatively scheduled to have concomitant procedures with coronary artery bypass graft procedure.\n* Scheduled to receive only one incision (a median sternotomy) without a planned saphenous vein graft and/or a radial artery graft donor site.\n* Renal dialysis currently or within 30 days of visit 1.\n* Morbid Obesity (Subjects with a Body Mass Index (BMI) \\> 37).\n* Neutropenia (absolute neutrophil count \\<1000/mm3).\n* Pre-operatively on an intra-aortic balloon pump or mechanical assist device.\n* Has received an experimental drug or used an experimental medical device within 30 days prior to Visit 1.\n* Employees of the investigator or study center with direct involvement in the proposed study or other studies under the direction of that investigator or study center.\n* Any condition, which in the opinion of the investigator would exclude the subject from the study.\n* Patients on steroid use for more than 1 week within 30 days of visit 1.\n* Patients on immunosuppressive therapy within 30 days of visit 1.\n* Depilatory creams with containing antibiotics.'}, 'identificationModule': {'nctId': 'NCT00467857', 'briefTitle': 'Study of the Combination of a Cyanoacrylate and Surgical Solutions in Reducing Skin Flora Contamination', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kimberly-Clark Corporation'}, 'officialTitle': 'A Randomized, Controlled, Parallel Group, Multi-center, Open Label Study Comparing Common Surgical Skin Preparation Solutions in Combination With InteguSeal Versus Common Surgical Skin Preparation Solutions to Reduce Skin Flora Contamination.', 'orgStudyIdInfo': {'id': 'IS 100-06-0001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'InteguSeal* and standard surgical preparation solutions', 'description': 'InteguSeal\\* microbial skin sealant was applied to surgical sites prior to incision after standard surgical skin preparation in patients undergoing coronary artery bypass graft (CABG) surgery', 'interventionNames': ['Procedure: InteguSeal* skin sealant and standard surgical preparation']}, {'type': 'OTHER', 'label': 'Standard surgical skin preparation alone', 'description': 'Prior to incision, standard surgical skin preparation in patients undergoing coronary artery bypass graft (CABG) surgery', 'interventionNames': ['Other: Standard preoperative skin preparation']}], 'interventions': [{'name': 'InteguSeal* skin sealant and standard surgical preparation', 'type': 'PROCEDURE', 'otherNames': ['Kimberly Clark InteguSeal* Microbial Sealant'], 'description': 'Surgical skin preparation prior to incision using InteguSeal\\* skin sealant following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.', 'armGroupLabels': ['InteguSeal* and standard surgical preparation solutions']}, {'name': 'Standard preoperative skin preparation', 'type': 'OTHER', 'description': 'Surgical skin preparation prior to incision using standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.', 'armGroupLabels': ['Standard surgical skin preparation alone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30060', 'city': 'Marietta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Wellstar Health Systems', 'geoPoint': {'lat': 33.9526, 'lon': -84.54993}}, {'zip': '05403', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Heart Institute- Dept of Thoracic Surgery', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'Temuco', 'country': 'Chile', 'facility': 'Hospital Dr. Hernan Henriquez Aravena', 'geoPoint': {'lat': -38.73628, 'lon': -72.59738}}, {'zip': 'D-10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charité, Humboldt University- Department of Cardiovascular Surgery', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': 'S168752', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'National Heart Centre', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'overallOfficials': [{'name': 'Charlotte D Owens, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Kimberly-Clark Corporation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kimberly-Clark Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}