Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2026-01-04 @ 3:21 PM
Study NCT ID:
NCT03385304
Status:
COMPLETED
Last Update Posted:
2023-03-31
First Post:
2017-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pre-operative Aqueous Antiseptic Skin Solutions in Open Fractures
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-12-14', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D013530', 'term': 'Surgical Wound Infection'}, {'id': 'D005597', 'term': 'Fractures, Open'}], 'ancestors': [{'id': 'D014946', 'term': 'Wound Infection'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011206', 'term': 'Povidone-Iodine'}, {'id': 'C010882', 'term': 'chlorhexidine gluconate'}, {'id': 'D002864', 'term': 'Chromogranins'}], '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'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011498', 'term': 'Protein Precursors'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ahowe@som.umaryland.edu', 'phone': '410-706-6823', 'title': 'Research Administrator', 'organization': 'University of Maryland, Baltimore'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The uncontrolled use of adjunctive skin preparations before final antisepsis is a potential limitation of our study design. Although the use of a prewash with adjunctive alcohol was similarly distributed between the treatment groups, post-randomization confounding from this practice might exist. The trial has other limitations, including unmasked treatment allocation and the decision to initiate each recruitment site as soon as possible.'}}, 'adverseEventsModule': {'timeFrame': '1 year post injury', 'description': 'This study did not collect data regarding "Other (Not Including Serious) Adverse Events".', 'eventGroups': [{'id': 'EG000', 'title': '10% Povidone-iodine (1% Free Iodine) in Purified Water', 'description': "The povidone-iodine solution will contain 10% povidone-iodine (1% free iodine) in purified water as the only active ingredient. Operating room personnel will apply the solution to the operative site as the final preoperative skin antisepsis preparation immediately prior to commencing surgical fixation. They will apply the solution as per manufacturer's directions for use (e.g., technique of application, duration of application, drying time, drying techniques, replacement of draping, etc.).\n\n10% povidone-iodine (1% free iodine) in purified water: Participant recruitment will begin with the clinical sites using their assigned pre-operative antiseptic skin solution for all open fracture surgeries for a two-month period.\n\n4% chlorhexidine gluconate (CHG) in purified water: Once the first intervention phase is completed, each site will crossover to the opposite study solution. Each site will need to develop local procedures to ensure a successful crossover. They will use the second solution for all open fracture surgeries for a two-month period, and will then crossover back to the solution in the first intervention phase.", 'otherNumAtRisk': 0, 'deathsNumAtRisk': 828, 'otherNumAffected': 0, 'seriousNumAtRisk': 828, 'deathsNumAffected': 19, 'seriousNumAffected': 365}, {'id': 'EG001', 'title': '4% Chlorhexidine Gluconate (CHG) in Purified Water', 'description': "The CHG solution will contain 4% CHG in purified water as the only active ingredient. Operating room personnel will apply the solution to the operative site as the final preoperative skin antisepsis preparation immediately prior to commencing surgical fixation. They will apply the solution as per manufacturer's directions (e.g., technique of application, duration of application, drying time, replacement of draping, etc.).\n\n10% povidone-iodine (1% free iodine) in purified water: Participant recruitment will begin with the clinical sites using their assigned pre-operative antiseptic skin solution for all open fracture surgeries for a two-month period.\n\n4% chlorhexidine gluconate (CHG) in purified water: Once the first intervention phase is completed, each site will crossover to the opposite study solution. Each site will need to develop local procedures to ensure a successful crossover. They will use the second solution for all open fracture surgeries for a two-month period, and will then crossover back to the solution in the first intervention phase.", 'otherNumAtRisk': 0, 'deathsNumAtRisk': 810, 'otherNumAffected': 0, 'seriousNumAtRisk': 810, 'deathsNumAffected': 7, 'seriousNumAffected': 368}], 'seriousEvents': [{'term': 'Study Fracture Related Complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 828, 'numEvents': 178, 'numAffected': 178}, {'groupId': 'EG001', 'numAtRisk': 810, 'numEvents': 192, 'numAffected': 192}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-Study Fracture Related Complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 828, 'numEvents': 23, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 810, 'numEvents': 31, 'numAffected': 31}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neurological', 'stats': [{'groupId': 'EG000', 'numAtRisk': 828, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 810, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 828, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 810, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac', 'stats': [{'groupId': 'EG000', 'numAtRisk': 828, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 810, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vascular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 828, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 810, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastro-Intestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 828, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 810, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 828, 'numEvents': 26, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 810, 'numEvents': 25, 'numAffected': 25}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 828, 'numEvents': 95, 'numAffected': 95}, {'groupId': 'EG001', 'numAtRisk': 810, 'numEvents': 69, 'numAffected': 69}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With a Superficial Incisional Surgical Site Infection (SSI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '787', 'groupId': 'OG000'}, {'value': '784', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '10% Povidone-iodine (1% Free Iodine) in Purified Water', 'description': "The povidone-iodine solution will contain 10% povidone-iodine (1% free iodine) in purified water as the only active ingredient. Operating room personnel will apply the solution to the operative site as the final preoperative skin antisepsis preparation immediately prior to commencing surgical fixation. They will apply the solution as per manufacturer's directions for use (e.g., technique of application, duration of application, drying time, drying techniques, replacement of draping, etc.).\n\n10% povidone-iodine (1% free iodine) in purified water: Participant recruitment will begin with the clinical sites using their assigned pre-operative antiseptic skin solution for all open fracture surgeries for a two-month period.\n\n4% chlorhexidine gluconate (CHG) in purified water: Once the first intervention phase is completed, each site will crossover to the opposite study solution. Each site will need to develop local procedures to ensure a successful crossover. They will use the second solution for all open fracture surgeries for a two-month period, and will then crossover back to the solution in the first intervention phase."}, {'id': 'OG001', 'title': '4% Chlorhexidine Gluconate (CHG) in Purified Water', 'description': "The CHG solution will contain 4% CHG in purified water as the only active ingredient. Operating room personnel will apply the solution to the operative site as the final preoperative skin antisepsis preparation immediately prior to commencing surgical fixation. They will apply the solution as per manufacturer's directions (e.g., technique of application, duration of application, drying time, replacement of draping, etc.).\n\n10% povidone-iodine (1% free iodine) in purified water: Participant recruitment will begin with the clinical sites using their assigned pre-operative antiseptic skin solution for all open fracture surgeries for a two-month period.\n\n4% chlorhexidine gluconate (CHG) in purified water: Once the first intervention phase is completed, each site will crossover to the opposite study solution. Each site will need to develop local procedures to ensure a successful crossover. They will use the second solution for all open fracture surgeries for a two-month period, and will then crossover back to the solution in the first intervention phase."}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': "Within 30 days of the patient's last planned fracture management surgery", 'description': 'Guided by the Centers for Disease Control and Prevention (CDC) National Healthcare Safety Network reporting criteria (2017):\n\nDate of event for infection may occur from the date of fracture to 30 days after the definitive fracture management surgery; AND involves only skin and subcutaneous tissue of the incision; AND patient has at least one of the following:\n\n1. purulent drainage from the superficial incision.\n2. organisms identified from an aseptically obtained specimen from the superficial incision or subcutaneous tissue by a culture or non-culture based microbiologic testing method which is performed for purposes of clinical diagnosis or treatment\n3. superficial incision that is deliberately opened by a surgeon, and culture or non-culture-based testing is not performed. AND patient has at least one of the following signs or symptoms: pain or tenderness; localized swelling; erythema; or heat.\n4. diagnosis of a superficial incisional SSI by the surgeon.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants With a Deep Incisional or Organ/Space Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '787', 'groupId': 'OG000'}, {'value': '784', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '10% Povidone-iodine (1% Free Iodine) in Purified Water', 'description': "The povidone-iodine solution will contain 10% povidone-iodine (1% free iodine) in purified water as the only active ingredient. Operating room personnel will apply the solution to the operative site as the final preoperative skin antisepsis preparation immediately prior to commencing surgical fixation. They will apply the solution as per manufacturer's directions for use (e.g., technique of application, duration of application, drying time, drying techniques, replacement of draping, etc.).\n\n10% povidone-iodine (1% free iodine) in purified water: Participant recruitment will begin with the clinical sites using their assigned pre-operative antiseptic skin solution for all open fracture surgeries for a two-month period.\n\n4% chlorhexidine gluconate (CHG) in purified water: Once the first intervention phase is completed, each site will crossover to the opposite study solution. Each site will need to develop local procedures to ensure a successful crossover. They will use the second solution for all open fracture surgeries for a two-month period, and will then crossover back to the solution in the first intervention phase."}, {'id': 'OG001', 'title': '4% Chlorhexidine Gluconate (CHG) in Purified Water', 'description': "The CHG solution will contain 4% CHG in purified water as the only active ingredient. Operating room personnel will apply the solution to the operative site as the final preoperative skin antisepsis preparation immediately prior to commencing surgical fixation. They will apply the solution as per manufacturer's directions (e.g., technique of application, duration of application, drying time, replacement of draping, etc.).\n\n10% povidone-iodine (1% free iodine) in purified water: Participant recruitment will begin with the clinical sites using their assigned pre-operative antiseptic skin solution for all open fracture surgeries for a two-month period.\n\n4% chlorhexidine gluconate (CHG) in purified water: Once the first intervention phase is completed, each site will crossover to the opposite study solution. Each site will need to develop local procedures to ensure a successful crossover. They will use the second solution for all open fracture surgeries for a two-month period, and will then crossover back to the solution in the first intervention phase."}], 'classes': [{'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': "Within 90 days of the patient's last planned fracture management surgery", 'description': "Guided by CDC's National Healthcare Safety Network Surgical Site Infection reporting criteria (2017):\n\nDeep Incisional Infection:\n\nOccurs within 90 days post definitive fracture management; \\& involves fascial/muscle layers; \\& has at least one of the following:\n\n1. deep incision purulent drainage\n2. a deep incision that dehisces, or is opened by a surgeon, and organism is identified by microbiologic testing; or microbiologic testing is not performed \\& has at least one of the following: fever (\\> 38 °C); localized pain or tenderness\n3. other evidence of deep incision infection on anatomical exam or imaging test\n\nOrgan/Space Infection:\n\nOccurs within 90 days post definitive fracture management; \\& involves any part of the body deeper than the fascial/muscle layers; \\& has at least one of the following:\n\n1. organ/space purulent drainage\n2. organisms in organ/space identified by microbiologic testing\n3. other evidence of organ/space infection on anatomical exam or imaging test", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With an Unplanned Fracture-Related Reoperation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '734', 'groupId': 'OG000'}, {'value': '738', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '10% Povidone-iodine (1% Free Iodine) in Purified Water', 'description': "The povidone-iodine solution will contain 10% povidone-iodine (1% free iodine) in purified water as the only active ingredient. Operating room personnel will apply the solution to the operative site as the final preoperative skin antisepsis preparation immediately prior to commencing surgical fixation. They will apply the solution as per manufacturer's directions for use (e.g., technique of application, duration of application, drying time, drying techniques, replacement of draping, etc.).\n\n10% povidone-iodine (1% free iodine) in purified water: Participant recruitment will begin with the clinical sites using their assigned pre-operative antiseptic skin solution for all open fracture surgeries for a two-month period.\n\n4% chlorhexidine gluconate (CHG) in purified water: Once the first intervention phase is completed, each site will crossover to the opposite study solution. Each site will need to develop local procedures to ensure a successful crossover. They will use the second solution for all open fracture surgeries for a two-month period, and will then crossover back to the solution in the first intervention phase."}, {'id': 'OG001', 'title': '4% Chlorhexidine Gluconate (CHG) in Purified Water', 'description': "The CHG solution will contain 4% CHG in purified water as the only active ingredient. Operating room personnel will apply the solution to the operative site as the final preoperative skin antisepsis preparation immediately prior to commencing surgical fixation. They will apply the solution as per manufacturer's directions (e.g., technique of application, duration of application, drying time, replacement of draping, etc.).\n\n10% povidone-iodine (1% free iodine) in purified water: Participant recruitment will begin with the clinical sites using their assigned pre-operative antiseptic skin solution for all open fracture surgeries for a two-month period.\n\n4% chlorhexidine gluconate (CHG) in purified water: Once the first intervention phase is completed, each site will crossover to the opposite study solution. Each site will need to develop local procedures to ensure a successful crossover. They will use the second solution for all open fracture surgeries for a two-month period, and will then crossover back to the solution in the first intervention phase."}], 'classes': [{'categories': [{'measurements': [{'value': '118', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': "Within 12 months of the patient's last planned operation", 'description': 'Common examples include any unplanned fracture-related surgery that is associated with an infection at the operative site or contiguous to it, a wound-healing problem, or a fracture delayed union or non-union.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary and secondary outcomes were evaluated using a complete case analysis. For that reason, the overall number of participants analyzed differs from the numbers provided under the Participant Flow module.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '10% Povidone-iodine (1% Free Iodine) in Purified Water', 'description': "The povidone-iodine solution will contain 10% povidone-iodine (1% free iodine) in purified water as the only active ingredient. Operating room personnel will apply the solution to the operative site as the final preoperative skin antisepsis preparation immediately prior to commencing surgical fixation. They will apply the solution as per manufacturer's directions for use (e.g., technique of application, duration of application, drying time, drying techniques, replacement of draping, etc.).\n\n10% povidone-iodine (1% free iodine) in purified water: Participant recruitment will begin with the clinical sites using their assigned pre-operative antiseptic skin solution for all open fracture surgeries for a two-month period.\n\n4% chlorhexidine gluconate (CHG) in purified water: Once the first intervention phase is completed, each site will crossover to the opposite study solution. Each site will need to develop local procedures to ensure a successful crossover. They will use the second solution for all open fracture surgeries for a two-month period, and will then crossover back to the solution in the first intervention phase."}, {'id': 'FG001', 'title': '4% Chlorhexidine Gluconate (CHG) in Purified Water', 'description': "The CHG solution will contain 4% CHG in purified water as the only active ingredient. Operating room personnel will apply the solution to the operative site as the final preoperative skin antisepsis preparation immediately prior to commencing surgical fixation. They will apply the solution as per manufacturer's directions (e.g., technique of application, duration of application, drying time, replacement of draping, etc.).\n\n10% povidone-iodine (1% free iodine) in purified water: Participant recruitment will begin with the clinical sites using their assigned pre-operative antiseptic skin solution for all open fracture surgeries for a two-month period.\n\n4% chlorhexidine gluconate (CHG) in purified water: Once the first intervention phase is completed, each site will crossover to the opposite study solution. Each site will need to develop local procedures to ensure a successful crossover. They will use the second solution for all open fracture surgeries for a two-month period, and will then crossover back to the solution in the first intervention phase."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Total Study Duration', 'achievements': [{'groupId': 'FG000', 'numUnits': '7', 'numSubjects': '828'}, {'groupId': 'FG001', 'numUnits': '7', 'numSubjects': '810'}]}, {'type': 'Months 1-2', 'achievements': [{'groupId': 'FG000', 'numUnits': '7', 'numSubjects': '114'}, {'groupId': 'FG001', 'numUnits': '7', 'numSubjects': '108'}]}, {'type': 'Months 3-4', 'achievements': [{'groupId': 'FG000', 'numUnits': '7', 'numSubjects': '102'}, {'groupId': 'FG001', 'numUnits': '7', 'numSubjects': '104'}]}, {'type': 'Months 5-6', 'achievements': [{'groupId': 'FG000', 'numUnits': '7', 'numSubjects': '98'}, {'groupId': 'FG001', 'numUnits': '5', 'numSubjects': '53'}]}, {'type': 'Months 7-8', 'achievements': [{'groupId': 'FG000', 'numUnits': '5', 'numSubjects': '50'}, {'groupId': 'FG001', 'numUnits': '7', 'numSubjects': '68'}]}, {'type': 'Months 9-10', 'achievements': [{'groupId': 'FG000', 'numUnits': '6', 'numSubjects': '91'}, {'groupId': 'FG001', 'numUnits': '5', 'numSubjects': '63'}]}, {'type': 'Months 11-12', 'achievements': [{'groupId': 'FG000', 'numUnits': '5', 'numSubjects': '72'}, {'groupId': 'FG001', 'numUnits': '5', 'numSubjects': '75'}]}, {'type': 'Months 13-14', 'achievements': [{'groupId': 'FG000', 'numUnits': '5', 'numSubjects': '62'}, {'groupId': 'FG001', 'numUnits': '4', 'numSubjects': '50'}]}, {'type': 'Months 15-16', 'achievements': [{'groupId': 'FG000', 'numUnits': '4', 'numSubjects': '38'}, {'groupId': 'FG001', 'numUnits': '5', 'numSubjects': '55'}]}, {'type': 'Months 17-18', 'achievements': [{'groupId': 'FG000', 'numUnits': '5', 'numSubjects': '38'}, {'groupId': 'FG001', 'numUnits': '5', 'numSubjects': '44'}]}, {'type': 'Months 19-20', 'achievements': [{'groupId': 'FG000', 'numUnits': '5', 'numSubjects': '32'}, {'groupId': 'FG001', 'numUnits': '3', 'numSubjects': '46'}]}, {'type': 'Months 21-22', 'achievements': [{'groupId': 'FG000', 'numUnits': '4', 'numSubjects': '50'}, {'groupId': 'FG001', 'numUnits': '5', 'numSubjects': '40'}]}, {'type': 'Months 23-24', 'achievements': [{'groupId': 'FG000', 'numUnits': '4', 'numSubjects': '30'}, {'groupId': 'FG001', 'numUnits': '5', 'numSubjects': '64'}]}, {'type': 'Months 25-26', 'achievements': [{'groupId': 'FG000', 'numUnits': '1', 'numSubjects': '22'}, {'groupId': 'FG001', 'numUnits': '1', 'numSubjects': '14'}]}, {'type': 'Months 27-28', 'achievements': [{'groupId': 'FG000', 'numUnits': '1', 'numSubjects': '21'}, {'groupId': 'FG001', 'numUnits': '1', 'numSubjects': '18'}]}, {'type': 'Months 29-30', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '1', 'numSubjects': '8'}]}, {'type': 'Months 31-32', 'achievements': [{'groupId': 'FG000', 'numUnits': '1', 'numSubjects': '8'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'comment': 'Total Study Duration', 'achievements': [{'groupId': 'FG000', 'numUnits': '7', 'numSubjects': '787'}, {'groupId': 'FG001', 'numUnits': '7', 'numSubjects': '784'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '41'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '26'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Incarceration', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'typeUnitsAnalyzed': 'Clinical Sites', 'recruitmentDetails': 'Recruitment occurred between April 8, 2018, and June 8, 2021 at 14 hospitals in Canada, Spain and the USA. Eligible patients were adults aged 18 years or older with an open extremity fracture treated with a surgical fixation implant. For inclusion, the open fracture required formal surgical debridement within 72 hours of the injury.', 'preAssignmentDetails': "To ensure wide generalizability to routine practice, the protocol allowed prewashing of the operative extremity with alcohol or other antiseptics before performing the final skin antisepsis with the study solution. In addition to ensuring trial feasibility and protocol adherence, this decision pragmatically allowed the intact skin to receive mechanical scrubbing or partial alcohol antisepsis at the treating surgeon's discretion."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '828', 'groupId': 'BG000'}, {'value': '810', 'groupId': 'BG001'}, {'value': '1638', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '10% Povidone-iodine (1% Free Iodine) in Purified Water', 'description': "The povidone-iodine solution will contain 10% povidone-iodine (1% free iodine) in purified water as the only active ingredient. Operating room personnel will apply the solution to the operative site as the final preoperative skin antisepsis preparation immediately prior to commencing surgical fixation. They will apply the solution as per manufacturer's directions for use (e.g., technique of application, duration of application, drying time, drying techniques, replacement of draping, etc.).\n\n10% povidone-iodine (1% free iodine) in purified water: Participant recruitment will begin with the clinical sites using their assigned pre-operative antiseptic skin solution for all open fracture surgeries for a two-month period.\n\n4% chlorhexidine gluconate (CHG) in purified water: Once the first intervention phase is completed, each site will crossover to the opposite study solution. Each site will need to develop local procedures to ensure a successful crossover. They will use the second solution for all open fracture surgeries for a two-month period, and will then crossover back to the solution in the first intervention phase."}, {'id': 'BG001', 'title': '4% Chlorhexidine Gluconate (CHG) in Purified Water', 'description': "The CHG solution will contain 4% CHG in purified water as the only active ingredient. Operating room personnel will apply the solution to the operative site as the final preoperative skin antisepsis preparation immediately prior to commencing surgical fixation. They will apply the solution as per manufacturer's directions (e.g., technique of application, duration of application, drying time, replacement of draping, etc.).\n\n10% povidone-iodine (1% free iodine) in purified water: Participant recruitment will begin with the clinical sites using their assigned pre-operative antiseptic skin solution for all open fracture surgeries for a two-month period.\n\n4% chlorhexidine gluconate (CHG) in purified water: Once the first intervention phase is completed, each site will crossover to the opposite study solution. Each site will need to develop local procedures to ensure a successful crossover. They will use the second solution for all open fracture surgeries for a two-month period, and will then crossover back to the solution in the first intervention phase."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'Age', 'categories': [{'measurements': [{'value': '45.2', 'spread': '18.2', 'groupId': 'BG000'}, {'value': '44.5', 'spread': '17.9', 'groupId': 'BG001'}, {'value': '44.9', 'spread': '18.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '324', 'groupId': 'BG000'}, {'value': '303', 'groupId': 'BG001'}, {'value': '627', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '504', 'groupId': 'BG000'}, {'value': '507', 'groupId': 'BG001'}, {'value': '1011', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'categories': [{'title': 'White', 'measurements': [{'value': '665', 'groupId': 'BG000'}, {'value': '624', 'groupId': 'BG001'}, {'value': '1289', 'groupId': 'BG002'}]}, {'title': 'Black', 'measurements': [{'value': '124', 'groupId': 'BG000'}, {'value': '137', 'groupId': 'BG001'}, {'value': '261', 'groupId': 'BG002'}]}, {'title': 'Central or South American', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Prefer not to answer', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Indigenous', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'Multiracial', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'BMI', 'classes': [{'categories': [{'title': 'Underweight (<18.5 kg/m^2)', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'Healthy weight (18.5 - 24.9 kg/m^2)', 'measurements': [{'value': '243', 'groupId': 'BG000'}, {'value': '200', 'groupId': 'BG001'}, {'value': '443', 'groupId': 'BG002'}]}, {'title': 'Overweight (25.0-29.9 kg/m^2)', 'measurements': [{'value': '247', 'groupId': 'BG000'}, {'value': '271', 'groupId': 'BG001'}, {'value': '518', 'groupId': 'BG002'}]}, {'title': 'Obesity (>30.0 kg/m^2)', 'measurements': [{'value': '329', 'groupId': 'BG000'}, {'value': '329', 'groupId': 'BG001'}, {'value': '658', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "BMI (Body Mass Index) \\[kg/m\\^2\\] was determined by collecting each participant's weight and height", 'unitOfMeasure': 'Participants'}, {'title': 'Diabetes of any type', 'classes': [{'categories': [{'measurements': [{'value': '94', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '170', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Current smoker', 'classes': [{'categories': [{'measurements': [{'value': '293', 'groupId': 'BG000'}, {'value': '274', 'groupId': 'BG001'}, {'value': '567', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'American Society of Anesthesiologist (ASA) Physical Score', 'classes': [{'categories': [{'title': 'Class I or II', 'measurements': [{'value': '423', 'groupId': 'BG000'}, {'value': '436', 'groupId': 'BG001'}, {'value': '859', 'groupId': 'BG002'}]}, {'title': 'Class III or higher', 'measurements': [{'value': '405', 'groupId': 'BG000'}, {'value': '374', 'groupId': 'BG001'}, {'value': '779', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "The American Society of Anesthesiologist (ASA) score is a subjective assessment of a patient's overall health that is based on five classes (I to V).\n\nI. Patient is a completely healthy fit patient. II. Patient has mild systemic disease. III. Patient has severe systemic disease that is not incapacitating. IV. Patient has incapacitating disease that is a constant threat to life. V. A moribund patient who is not expected to live 24 hour with or without surgery.", 'unitOfMeasure': 'Participants'}, {'title': 'Number of included open fractures per participant', 'classes': [{'categories': [{'title': 'One', 'measurements': [{'value': '775', 'groupId': 'BG000'}, {'value': '753', 'groupId': 'BG001'}, {'value': '1528', 'groupId': 'BG002'}]}, {'title': 'Two', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}]}, {'title': 'Three', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-11-04', 'size': 1149388, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-11-08T11:32', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The orthopaedic team (including the study coordinators) cannot be blinded to the treatment allocation as the antiseptic solutions are visually distinguishable and these individuals need to lead the implementation of the cluster-crossover protocol at their clinical site. The Adjudication Committee Members and data analysts will be blinded to the study treatment. All interpretation of study results will initially be done in a blinded manner by developing two interpretations of the results. One interpretation will assume treatment A is povidone-iodine, the other interpretation will assume it is CHG. Once the data interpretations for each assumption are finalized, the data will be unblinded and the correct interpretation will be accepted.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Treatment allocation will be determined using a cluster-randomized crossover trial design. The order of treatment allocation for each orthopaedic practice will be randomly assigned using a computer generated randomization table. Each site will start with the initially allocated study solution and eventually crossover to the other solution for their second recruitment period. This process of alternating treatments will repeat approximately every 2 months as dictated by the initial randomization.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1638}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2022-06-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-06', 'studyFirstSubmitDate': '2017-12-20', 'resultsFirstSubmitDate': '2022-11-15', 'studyFirstSubmitQcDate': '2017-12-20', 'lastUpdatePostDateStruct': {'date': '2023-03-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-03-06', 'studyFirstPostDateStruct': {'date': '2017-12-28', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-03-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With a Superficial Incisional Surgical Site Infection (SSI)', 'timeFrame': "Within 30 days of the patient's last planned fracture management surgery", 'description': 'Guided by the Centers for Disease Control and Prevention (CDC) National Healthcare Safety Network reporting criteria (2017):\n\nDate of event for infection may occur from the date of fracture to 30 days after the definitive fracture management surgery; AND involves only skin and subcutaneous tissue of the incision; AND patient has at least one of the following:\n\n1. purulent drainage from the superficial incision.\n2. organisms identified from an aseptically obtained specimen from the superficial incision or subcutaneous tissue by a culture or non-culture based microbiologic testing method which is performed for purposes of clinical diagnosis or treatment\n3. superficial incision that is deliberately opened by a surgeon, and culture or non-culture-based testing is not performed. AND patient has at least one of the following signs or symptoms: pain or tenderness; localized swelling; erythema; or heat.\n4. diagnosis of a superficial incisional SSI by the surgeon.'}, {'measure': 'Number of Participants With a Deep Incisional or Organ/Space Infection', 'timeFrame': "Within 90 days of the patient's last planned fracture management surgery", 'description': "Guided by CDC's National Healthcare Safety Network Surgical Site Infection reporting criteria (2017):\n\nDeep Incisional Infection:\n\nOccurs within 90 days post definitive fracture management; \\& involves fascial/muscle layers; \\& has at least one of the following:\n\n1. deep incision purulent drainage\n2. a deep incision that dehisces, or is opened by a surgeon, and organism is identified by microbiologic testing; or microbiologic testing is not performed \\& has at least one of the following: fever (\\> 38 °C); localized pain or tenderness\n3. other evidence of deep incision infection on anatomical exam or imaging test\n\nOrgan/Space Infection:\n\nOccurs within 90 days post definitive fracture management; \\& involves any part of the body deeper than the fascial/muscle layers; \\& has at least one of the following:\n\n1. organ/space purulent drainage\n2. organisms in organ/space identified by microbiologic testing\n3. other evidence of organ/space infection on anatomical exam or imaging test"}], 'secondaryOutcomes': [{'measure': 'Number of Participants With an Unplanned Fracture-Related Reoperation', 'timeFrame': "Within 12 months of the patient's last planned operation", 'description': 'Common examples include any unplanned fracture-related surgery that is associated with an infection at the operative site or contiguous to it, a wound-healing problem, or a fracture delayed union or non-union.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Surgical Site Infection', 'Open Fracture', 'Povidone-iodine', 'Chlorhexidine gluconate', 'Peri-operative Preparation Solutions'], 'conditions': ['Surgical Site Infection', 'Unplanned Fracture-Related Reoperation', 'Open Appendicular Fracture']}, 'referencesModule': {'references': [{'pmid': '36096826', 'type': 'BACKGROUND', 'citation': "O'Hara NN, Heels-Ansdell D, Bzovsky S, Dodds S, Thabane L, Bhandari M, Guyatt G, Devereaux PJ, Slobogean GP, Sprague S; PREP-IT Investigators. A pragmatic randomized trial evaluating pre-operative aqueous antiseptic skin solutions in open fractures (Aqueous-PREP): statistical analysis plan. Trials. 2022 Sep 12;23(1):772. doi: 10.1186/s13063-022-06541-0."}, {'pmid': '36244384', 'type': 'DERIVED', 'citation': 'PREP-IT Investigators. Aqueous skin antisepsis before surgical fixation of open fractures (Aqueous-PREP): a multiple-period, cluster-randomised, crossover trial. Lancet. 2022 Oct 15;400(10360):1334-1344. doi: 10.1016/S0140-6736(22)01652-X.'}, {'pmid': '33648577', 'type': 'DERIVED', 'citation': "Sprague S, Guyatt P, Bzovsky S, Nguyen U, Bhandari M, Thabane L, Petrisor B, Johal HS, Leonard J, Dodds S, Mossuto F, O'Toole RV, Howe A, Demyanovich HK, Camara M, O'Hara NN, Slobogean GP; PREP-IT Investigators. Pragmatic randomized trial evaluating pre-operative aqueous antiseptic skin solution in open fractures (Aqueous-PREP): the feasibility of a cluster randomized crossover study. Pilot Feasibility Stud. 2021 Mar 1;7(1):61. doi: 10.1186/s40814-021-00800-8."}, {'pmid': '32787892', 'type': 'DERIVED', 'citation': "Sprague S, Scott T, Dodds S, Pogorzelski D, McKay P, Harris AD, Wood A, Thabane L, Bhandari M, Mehta S, Gaski G, Boulton C, Marcano-Fernandez F, Guerra-Farfan E, Hebden J, O'Hara LM, Slobogean GP; PREP-IT Investigators. Cluster identification, selection, and description in cluster randomized crossover trials: the PREP-IT trials. Trials. 2020 Aug 12;21(1):712. doi: 10.1186/s13063-020-04611-9."}, {'pmid': '32259266', 'type': 'DERIVED', 'citation': "Program of Randomized Trials to Evaluate Pre-operative Antiseptic Skin Solutions in Orthopaedic Trauma (PREP-IT) Investigators; Slobogean GP, Sprague S, Wells J, Bhandari M, Rojas A, Garibaldi A, Wood A, Howe A, Harris AD, Petrisor BA, Mullins DC, Pogorzelski D, Marvel D, Heels-Ansdell D, Mossuto F, Grissom F, Del Fabbro G, Guyatt GH, Della Rocca GJ, Demyanovich HK, Gitajn IL, Palmer J, D'Alleyrand JC, Friedrich J, Rivera J, Hebden J, Rudnicki J, Fowler J, Jeray KJ, Thabane L, Marchand L, O'Hara LM, Joshi MG, Talbot M, Camara M, Szasz OP, O'Hara NN, McKay P, Devereaux PJ, O'Toole RV, Zura R, Morshed S, Dodds S, Li S, Tanner SL, Scott T, Nguyen U. Effectiveness of Iodophor vs Chlorhexidine Solutions for Surgical Site Infections and Unplanned Reoperations for Patients Who Underwent Fracture Repair: The PREP-IT Master Protocol. JAMA Netw Open. 2020 Apr 1;3(4):e202215. doi: 10.1001/jamanetworkopen.2020.2215."}]}, 'descriptionModule': {'briefSummary': 'The prevention of infection is the single most important goal influencing peri-operative care of patients with open fractures. Standard practice in the management of open fractures includes sterile technique and pre-operative skin preparation with an antiseptic solution. The available solutions kill bacteria and decrease the quantity of native skin flora, thereby decreasing surgical site infection (SSI). While there is extensive guidance on specific procedures for prophylactic antibiotic use and standards for sterile technique, the evidence regarding the choice of antiseptic skin preparation solution is very limited for open fracture surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'The inclusion criteria are:\n\n1. Patients 18 years of age or older.\n2. Open fracture of the appendicular skeleton.\n3. Received or will receive definitive fracture treatment with a surgical implant(s) (e.g., internal fixation, external fixation, joint prosthesis, etc.).\n4. Open fracture wound management that includes formal surgical debridement within 72 hours of their injury.\n5. Will have all planned fracture care surgeries performed by a participating surgeon or delegate.\n6. Informed consent obtained.\n7. Patient enrolled within 3 weeks of their fracture.\n\nThe exclusion criteria are:\n\n1. Patients that did not or will not receive the allocated pre-operative surgical preparation solution due to a medical contraindication.\n2. Received previous surgical debridement or management of their open fracture at a non-participating hospital or clinic.\n3. Open fracture managed outside of the participating orthopaedic service (e.g., hand fracture managed by plastic surgeon).\n4. Chronic or acute infection at or near the fracture site at the time of initial fracture surgery.\n5. Burns at the fracture site.\n6. Incarceration.\n7. Expected injury survival of less than 90 days.\n8. Terminal illness with expected survival less than 90 days.\n9. Previous enrollment in a PREP-IT trial.\n10. Currently enrolled in a study that does not permit co-enrollment.\n11. Unable to obtain informed consent due to language barriers.\n12. Likely problems, in the judgment of study personnel, with maintaining follow-up with the patient.\n13. Excluded due to sampling strategy.'}, 'identificationModule': {'nctId': 'NCT03385304', 'acronym': 'Aqueous-PREP', 'briefTitle': 'Pre-operative Aqueous Antiseptic Skin Solutions in Open Fractures', 'organization': {'class': 'OTHER', 'fullName': 'University of Maryland, Baltimore'}, 'officialTitle': 'Aqueous-PREP: A Pragmatic Randomized Trial Evaluating Pre-operative Aqueous Antiseptic Skin Solutions in Open Fractures', 'orgStudyIdInfo': {'id': 'HP-00078470'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '10% povidone-iodine (1% free iodine) in purified water', 'description': "The povidone-iodine solution will contain 10% povidone-iodine (1% free iodine) in purified water as the only active ingredient. Operating room personnel will apply the solution to the operative site as the final preoperative skin antisepsis preparation immediately prior to commencing surgical fixation. They will apply the solution as per manufacturer's directions for use (e.g., technique of application, duration of application, drying time, drying techniques, replacement of draping, etc.).", 'interventionNames': ['Drug: 10% povidone-iodine (1% free iodine) in purified water', 'Drug: 4% chlorhexidine gluconate (CHG) in purified water']}, {'type': 'EXPERIMENTAL', 'label': '4% chlorhexidine gluconate (CHG) in purified water', 'description': "The CHG solution will contain 4% CHG in purified water as the only active ingredient. Operating room personnel will apply the solution to the operative site as the final preoperative skin antisepsis preparation immediately prior to commencing surgical fixation. They will apply the solution as per manufacturer's directions (e.g., technique of application, duration of application, drying time, replacement of draping, etc.).", 'interventionNames': ['Drug: 10% povidone-iodine (1% free iodine) in purified water', 'Drug: 4% chlorhexidine gluconate (CHG) in purified water']}], 'interventions': [{'name': '10% povidone-iodine (1% free iodine) in purified water', 'type': 'DRUG', 'description': 'Participant recruitment will begin with the clinical sites using their assigned pre-operative antiseptic skin solution for all open fracture surgeries for a two-month period.', 'armGroupLabels': ['10% povidone-iodine (1% free iodine) in purified water', '4% chlorhexidine gluconate (CHG) in purified water']}, {'name': '4% chlorhexidine gluconate (CHG) in purified water', 'type': 'DRUG', 'description': 'Once the first intervention phase is completed, each site will crossover to the opposite study solution. Each site will need to develop local procedures to ensure a successful crossover. They will use the second solution for all open fracture surgeries for a two-month period, and will then crossover back to the solution in the first intervention phase.', 'armGroupLabels': ['10% povidone-iodine (1% free iodine) in purified water', '4% chlorhexidine gluconate (CHG) in purified water']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85006', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'The CORE Institute / Banner University Medical Center', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85721', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Banner - University Medical Center Tucson', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '32611', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University Health Methodist Hospital', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland, R Adams Cowley Shock Trauma Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '45409', 'city': 'Dayton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Wright State University / Miami Valley Hospital', 'geoPoint': {'lat': 39.75895, 'lon': -84.19161}}, {'zip': '29605', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Greenville Health System', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '37240', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '78234', 'city': 'Fort Sam Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'San Antonio Military Medical Center', 'geoPoint': {'lat': 29.45303, 'lon': -98.4417}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'McGovern Medical School at University of Texas Health Science Center Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': 'L8L 2X2', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Hamilton Health Sciences', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'L8L 8E7', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'McMaster University, Center for Evidence-Based Orthopaedics', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Parc Tauli de Sabadell', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': "Vall d'Hebron University Hospital", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Gerard Slobogean, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Maryland, Baltimore'}, {'name': 'Sheila Sprague, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McMaster University'}, {'name': 'Mohit Bhandari, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McMaster University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Maryland, Baltimore', 'class': 'OTHER'}, 'collaborators': [{'name': 'McMaster University', 'class': 'OTHER'}, {'name': 'United States Department of Defense', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor, Department of Orthopaedics', 'investigatorFullName': 'Gerard Slobogean', 'investigatorAffiliation': 'University of Maryland, Baltimore'}}}}