Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2026-01-29 @ 1:39 PM
Study NCT ID:
NCT01968356
Status:
TERMINATED
Last Update Posted:
2024-10-02
First Post:
2013-10-21
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
In-vivo Efficacy Study of Patient Preoperative Preps
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019840', 'term': '2-Propanol'}, {'id': 'D002864', 'term': 'Chromogranins'}, {'id': 'C010882', 'term': 'chlorhexidine gluconate'}, {'id': 'D000431', 'term': 'Ethanol'}, {'id': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011498', 'term': 'Protein Precursors'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jepaulson@mmm.com', 'phone': '651-736-6583', 'title': 'Joan E. Paulson', 'organization': '3M Health Care'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events (AEs) were collected on treatment day (1 day), thus all AEs by definition would be treatment-emergent.', 'description': 'On Treatment Day, prior to collection of the baseline, 10-minute, and 6-hour post-prep samples, the skin in each test area will be evaluated for indications of skin irritation (dryness, edema, erythema, rash), based on the Skin Irritation Rating Scale: 0 = no reaction, 1 = mild, 2 = moderate, 3 = severe. A skin irritation rating of 3 in any category represents significant irritation and qualifies as an adverse event.', 'eventGroups': [{'id': 'EG000', 'title': '3M CHG/IPA Prep Tint Abdominal Region', 'description': 'Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator\n\n3M CHG/IPA Prep Tint: Apply topically.', 'otherNumAtRisk': 93, 'deathsNumAtRisk': 93, 'otherNumAffected': 0, 'seriousNumAtRisk': 93, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '3M CHG/IPA Prep Colorless Abdominal Region', 'description': 'Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator\n\n3M CHG/IPA Prep Colorless: Apply topically.', 'otherNumAtRisk': 101, 'deathsNumAtRisk': 101, 'otherNumAffected': 0, 'seriousNumAtRisk': 101, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'ChloraPrep CHG/IPA Hi-Lite Orange Tint Abdominal Region', 'description': 'Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator\n\nChloraPrep CHG/IPA Hi-Lite Orange Tint: Apply topically.', 'otherNumAtRisk': 96, 'deathsNumAtRisk': 96, 'otherNumAffected': 0, 'seriousNumAtRisk': 96, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Normal Saline Abdominal Region', 'description': '0.9% normal saline with applicator\n\nNormal Saline: Apply topically.', 'otherNumAtRisk': 32, 'deathsNumAtRisk': 32, 'otherNumAffected': 0, 'seriousNumAtRisk': 32, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': '3M CHG/IPA Prep Colorless Inguinal Region', 'description': 'Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator\n\n3M CHG/IPA Prep Colorless: Apply topically.', 'otherNumAtRisk': 97, 'deathsNumAtRisk': 97, 'otherNumAffected': 0, 'seriousNumAtRisk': 97, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': '3M CHG/IPA Prep Tint Inguinal Region', 'description': 'Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator\n\n3M CHG/IPA Prep Colorless: Apply topically.', 'otherNumAtRisk': 99, 'deathsNumAtRisk': 99, 'otherNumAffected': 0, 'seriousNumAtRisk': 99, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'ChloraPrep CHG/IPA Hi-Lite Orange Tint Inguinal Region', 'description': 'Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator\n\nChloraPrep CHG/IPA Hi-Lite Orange Tint: Apply topically.', 'otherNumAtRisk': 97, 'deathsNumAtRisk': 97, 'otherNumAffected': 0, 'seriousNumAtRisk': 97, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'Normal Saline Inguinal Region', 'description': '0.9% normal saline with applicator\n\nNormal Saline: Apply topically.', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 0, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Responder Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': '3M CHG/IPA Prep Colorless Abdominal Region', 'description': 'Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator\n\n3M CHG/IPA Prep Colorless: Apply topically.'}, {'id': 'OG001', 'title': '3M CHG/IPA Prep Tint Abdominal Region', 'description': 'Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator\n\n3M CHG/IPA Prep Tint: Apply topically.'}, {'id': 'OG002', 'title': 'ChloraPrep CHG/IPA Hi-Lite Orange Tint Abdominal Region', 'description': 'Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator\n\nChloraPrep CHG/IPA Hi-Lite Orange Tint: Apply topically.'}, {'id': 'OG003', 'title': 'Normal Saline Abdominal Region', 'description': '0.9% normal saline with applicator\n\nNormal Saline: Apply topically.'}, {'id': 'OG004', 'title': '3M CHG/IPA Prep Colorless Inguinal Region', 'description': 'Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator\n\n3M CHG/IPA Prep Colorless: Apply topically.'}, {'id': 'OG005', 'title': '3M CHG/IPA Prep Tint Inguinal Region', 'description': 'Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator\n\n3M CHG/IPA Prep Colorless: Apply topically.'}, {'id': 'OG006', 'title': 'ChloraPrep CHG/IPA Hi-Lite Orange Tint Inguinal Region', 'description': 'Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator\n\nChloraPrep CHG/IPA Hi-Lite Orange Tint: Apply topically.'}, {'id': 'OG007', 'title': 'Normal Saline Inguinal Region', 'description': '0.9% normal saline with applicator\n\nNormal Saline: Apply topically.'}], 'timeFrame': 'baseline, 10 minute post-product application and 6 hour post-product application', 'description': 'On the abdominal region a responder was a subject with a 2-log10/cm2 bacterial reduction at 10 minutes and for whom the skin flora did not return to baseline at 6 hours.\n\nOn the inguinal region a responder was a subject with a 3-log10/cm2 bacterial reduction at 10 minutes and for whom the skin flora did not return to baseline at 6 hours.', 'reportingStatus': 'POSTED', 'populationDescription': 'This study was discontinued prematurely due to technical and data quality issues. In agreement with the FDA no efficacy analysis was conducted. Thus, the efficacy objective of the study could not be evaluated.'}, {'type': 'PRIMARY', 'title': 'Skin Flora Baseline for Abdominal and Inguinal Regions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': '3M CHG/IPA Prep Colorless Abdominal Region', 'description': 'Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator\n\n3M CHG/IPA Prep Colorless: Apply topically.'}, {'id': 'OG001', 'title': '3M CHG/IPA Prep Tint Abdominal Region', 'description': 'Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator\n\n3M CHG/IPA Prep Tint: Apply topically.'}, {'id': 'OG002', 'title': 'ChloraPrep CHG/IPA Hi-Lite Orange Tint Abdominal Region', 'description': 'Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator\n\nChloraPrep CHG/IPA Hi-Lite Orange Tint: Apply topically.'}, {'id': 'OG003', 'title': 'Normal Saline Abdominal Region', 'description': '0.9% normal saline with applicator\n\nNormal Saline: Apply topically.'}, {'id': 'OG004', 'title': '3M CHG/IPA Prep Colorless Inguinal Region', 'description': 'Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator\n\n3M CHG/IPA Prep Colorless: Apply topically.'}, {'id': 'OG005', 'title': '3M CHG/IPA Prep Tint Inguinal Region', 'description': 'Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator\n\n3M CHG/IPA Prep Colorless: Apply topically.'}, {'id': 'OG006', 'title': 'ChloraPrep CHG/IPA Hi-Lite Orange Tint Inguinal Region', 'description': 'Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator\n\nChloraPrep CHG/IPA Hi-Lite Orange Tint: Apply topically.'}, {'id': 'OG007', 'title': 'Normal Saline Inguinal Region', 'description': '0.9% normal saline with applicator\n\nNormal Saline: Apply topically.'}], 'timeFrame': 'Baseline', 'description': 'Log10/cm2 baseline skin flora for abdominal and inguinal regions', 'reportingStatus': 'POSTED', 'populationDescription': 'This study was discontinued prematurely due to technical and data quality issues. In agreement with the FDA no efficacy analysis was conducted. Thus, the efficacy objective of the study could not be evaluated.'}, {'type': 'PRIMARY', 'title': 'Skin Flora Recovery Post-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': '3M CHG/IPA Prep Colorless - Abdominal', 'description': 'Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator applied topically to the abdominal region for 30 seconds\n\n3M CHG/IPA Prep Tint: Apply topically.\n\nChloraPrep: Apply topically.\n\nSaline: Apply topically.'}, {'id': 'OG001', 'title': '3M CHG/IPA Prep Tint - Abdominal', 'description': 'Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator applied topically to the abdominal region for 30 seconds\n\n3M CHG/IPA Prep Colorless: Apply topically.\n\nChloraPrep: Apply topically.\n\nSaline: Apply topically.'}, {'id': 'OG002', 'title': 'ChloraPrep Hi-Lite Orange - Abdominal', 'description': 'Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator applied topically to the abdominal region for 30 seconds\n\n3M CHG/IPA Prep Colorless: Apply topically.\n\n3M CHG/IPA Prep Tint: Apply topically.\n\nSaline: Apply topically.'}, {'id': 'OG003', 'title': 'Normal Saline - Abdominal', 'description': '0.9% normal saline applied topically to the abdominal region with applicator for 30 seconds\n\n3M CHG/IPA Prep Colorless: Apply topically.\n\n3M CHG/IPA Prep Tint: Apply topically.\n\nChloraPrep: Apply topically.'}, {'id': 'OG004', 'title': '3M CHG/IPA Prep Colorless - Inguinal', 'description': 'Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator applied topically to the inguinal region for 2 minutes\n\n3M CHG/IPA Prep Tint: Apply topically.\n\nChloraPrep: Apply topically.\n\nSaline: Apply topically.'}, {'id': 'OG005', 'title': '3M CHG/IPA Prep Tint - Inguinal', 'description': 'Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator applied topically to the inguinal region for 2 minutes\n\n3M CHG/IPA Prep Colorless: Apply topically.\n\nChloraPrep: Apply topically.\n\nSaline: Apply topically.'}, {'id': 'OG006', 'title': 'ChloraPrep Hi-Lite Orange - Inguinal', 'description': 'Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator applied topically to the inguinal region for 2 minutes\n\n3M CHG/IPA Prep Colorless: Apply topically.\n\n3M CHG/IPA Prep Tint: Apply topically.\n\nSaline: Apply topically.'}, {'id': 'OG007', 'title': 'Normal Saline - Inguinal', 'description': '0.9% normal saline applied topically to the inguinal region with applicator for 2 minutes\n\n3M CHG/IPA Prep Colorless: Apply topically.\n\n3M CHG/IPA Prep Tint: Apply topically.\n\nChloraPrep: Apply topically.'}], 'timeFrame': '10 minutes and 6 hours post-treatment', 'description': 'Log10/cm2 recovery of skin flora at 10 minutes and 6 hours following application of study treatments for abdominal and inguinal regions', 'reportingStatus': 'POSTED', 'populationDescription': 'This study was discontinued prematurely due to technical and data quality issues. In agreement with the FDA no efficacy analysis was conducted. Thus, the efficacy objective of the study could not be evaluated.'}, {'type': 'PRIMARY', 'title': 'Reduction of Skin Flora Post-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': '3M CHG/IPA Prep Colorless Abdominal Region', 'description': 'Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator\n\n3M CHG/IPA Prep Colorless: Apply topically.'}, {'id': 'OG001', 'title': '3M CHG/IPA Prep Tint Abdominal Region', 'description': 'Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator\n\n3M CHG/IPA Prep Tint: Apply topically.'}, {'id': 'OG002', 'title': 'ChloraPrep CHG/IPA Hi-Lite Orange Tint Abdominal Region', 'description': 'Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator\n\nChloraPrep CHG/IPA Hi-Lite Orange Tint: Apply topically.'}, {'id': 'OG003', 'title': 'Normal Saline Abdominal Region', 'description': '0.9% normal saline with applicator\n\nNormal Saline: Apply topically.'}, {'id': 'OG004', 'title': '3M CHG/IPA Prep Colorless Inguinal Region', 'description': 'Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator\n\n3M CHG/IPA Prep Colorless: Apply topically.'}, {'id': 'OG005', 'title': '3M CHG/IPA Prep Tint Inguinal Region', 'description': 'Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator\n\n3M CHG/IPA Prep Colorless: Apply topically.'}, {'id': 'OG006', 'title': 'ChloraPrep CHG/IPA Hi-Lite Orange Tint Inguinal Region', 'description': 'Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator\n\nChloraPrep CHG/IPA Hi-Lite Orange Tint: Apply topically.'}, {'id': 'OG007', 'title': 'Normal Saline Inguinal Region', 'description': '0.9% normal saline with applicator\n\nNormal Saline: Apply topically.'}], 'timeFrame': 'Baseline, 10 minutes and 6 hours', 'description': 'Log10/cm2 reduction of skin flora, relative to Treatment Day baseline log10/cm2, at 10 minutes and 6 hours', 'reportingStatus': 'POSTED', 'populationDescription': 'This study was discontinued prematurely due to technical and data quality issues. In agreement with the FDA no efficacy analysis was conducted. Thus, the efficacy objective of the study could not be evaluated.'}, {'type': 'SECONDARY', 'title': 'Safety as Assessed by Skin Irritation Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '96', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '97', 'groupId': 'OG004'}, {'value': '99', 'groupId': 'OG005'}, {'value': '97', 'groupId': 'OG006'}, {'value': '31', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': '3M CHG/IPA Prep Colorless Abdominal Region', 'description': 'Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator\n\n3M CHG/IPA Prep Colorless: Apply topically.'}, {'id': 'OG001', 'title': '3M CHG/IPA Prep Tint Abdominal Region', 'description': 'Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator\n\n3M CHG/IPA Prep Tint: Apply topically.'}, {'id': 'OG002', 'title': 'ChloraPrep CHG/IPA Hi-Lite Orange Tint Abdominal Region', 'description': 'Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator\n\nChloraPrep CHG/IPA Hi-Lite Orange Tint: Apply topically.'}, {'id': 'OG003', 'title': 'Normal Saline Abdominal Region', 'description': '0.9% normal saline with applicator\n\nNormal Saline: Apply topically.'}, {'id': 'OG004', 'title': '3M CHG/IPA Prep Colorless Inguinal Region', 'description': 'Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator\n\n3M CHG/IPA Prep Colorless: Apply topically.'}, {'id': 'OG005', 'title': '3M CHG/IPA Prep Tint Inguinal Region', 'description': 'Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator\n\n3M CHG/IPA Prep Colorless: Apply topically.'}, {'id': 'OG006', 'title': 'ChloraPrep CHG/IPA Hi-Lite Orange Tint Inguinal Region', 'description': 'Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator\n\nChloraPrep CHG/IPA Hi-Lite Orange Tint: Apply topically.'}, {'id': 'OG007', 'title': 'Normal Saline Inguinal Region', 'description': '0.9% normal saline with applicator\n\nNormal Saline: Apply topically.'}], 'classes': [{'title': 'Dryness-No reaction (0)', 'categories': [{'measurements': [{'value': '101', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '96', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '97', 'groupId': 'OG004'}, {'value': '97', 'groupId': 'OG005'}, {'value': '96', 'groupId': 'OG006'}, {'value': '30', 'groupId': 'OG007'}]}]}, {'title': 'Dryness-Mild (1)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}]}]}, {'title': 'Dryness-Moderate (2)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Dryness-Severe (3)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Edema-No reaction (0)', 'categories': [{'measurements': [{'value': '101', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '96', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '97', 'groupId': 'OG004'}, {'value': '98', 'groupId': 'OG005'}, {'value': '96', 'groupId': 'OG006'}, {'value': '31', 'groupId': 'OG007'}]}]}, {'title': 'Edema-Mild (1)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Edema-Moderate (2)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Edema-Severe (3)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Erythema- No reaction (0)', 'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '96', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}, {'value': '97', 'groupId': 'OG004'}, {'value': '97', 'groupId': 'OG005'}, {'value': '96', 'groupId': 'OG006'}, {'value': '30', 'groupId': 'OG007'}]}]}, {'title': 'Erythema-Mild (1)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}]}]}, {'title': 'Erythema-Moderate (2)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Erythema-Severe (3)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Rash-No Reaction (0)', 'categories': [{'measurements': [{'value': '101', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '96', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '97', 'groupId': 'OG004'}, {'value': '97', 'groupId': 'OG005'}, {'value': '96', 'groupId': 'OG006'}, {'value': '30', 'groupId': 'OG007'}]}]}, {'title': 'Rash-Mild (1)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 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{'id': 'OG006', 'title': 'ChloraPrep CHG/IPA Hi-Lite Orange Tint Inguinal Region', 'description': 'Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator\n\nChloraPrep CHG/IPA Hi-Lite Orange Tint: Apply topically.'}, {'id': 'OG007', 'title': 'Normal Saline Inguinal Region', 'description': '0.9% normal saline with applicator\n\nNormal Saline: Apply topically.'}], 'classes': [{'title': 'Dryness-No Reaction (0)', 'categories': [{'measurements': [{'value': '101', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '96', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '97', 'groupId': 'OG004'}, {'value': '97', 'groupId': 'OG005'}, {'value': '96', 'groupId': 'OG006'}, {'value': '30', 'groupId': 'OG007'}]}]}, {'title': 'Dryness-Mild (1)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 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[{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Erythema-No Reaction (0)', 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}, {'value': '96', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}, {'value': '96', 'groupId': 'OG004'}, {'value': '97', 'groupId': 'OG005'}, {'value': '96', 'groupId': 'OG006'}, {'value': '30', 'groupId': 'OG007'}]}]}, {'title': 'Erythema-Mild (1)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}]}]}, {'title': 'Erythema-Moderate (2)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Erythema-Severe (3)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Rash-No Reaction (0)', 'categories': [{'measurements': [{'value': '101', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '96', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '96', 'groupId': 'OG004'}, {'value': '97', 'groupId': 'OG005'}, {'value': '96', 'groupId': 'OG006'}, {'value': '30', 'groupId': 'OG007'}]}]}, {'title': 'Rash-Mild (1)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}]}]}, {'title': 'Rash-Moderate (2)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Rash-Severe (3)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '10 minutes post-treatment', 'description': 'Skin irritation rating (0-3) scores for dryness, edema, erythema and rash. 0 = no reaction, 1 = mild, 2 = moderate, 3 = severe. A skin irritation rating of 3 in any category represents significant irritation and qualifies as an adverse event.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '\\# of sites treated (met inclusion/exclusion criteria including screening day baseline counts'}, {'type': 'SECONDARY', 'title': 'Safety as Assessed by Skin Irritation Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '96', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '97', 'groupId': 'OG004'}, {'value': '99', 'groupId': 'OG005'}, {'value': '97', 'groupId': 'OG006'}, {'value': '31', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': '3M CHG/IPA Prep Colorless Abdominal Region', 'description': 'Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator\n\n3M CHG/IPA Prep Colorless: Apply topically.'}, {'id': 'OG001', 'title': '3M CHG/IPA 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{'id': 'OG006', 'title': 'ChloraPrep CHG/IPA Hi-Lite Orange Tint Inguinal Region', 'description': 'Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator\n\nChloraPrep CHG/IPA Hi-Lite Orange Tint: Apply topically.'}, {'id': 'OG007', 'title': 'Normal Saline Inguinal Region', 'description': '0.9% normal saline with applicator\n\nNormal Saline: Apply topically.'}], 'classes': [{'title': 'Dryness-No Reaction (0)', 'categories': [{'measurements': [{'value': '101', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '96', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '97', 'groupId': 'OG004'}, {'value': '99', 'groupId': 'OG005'}, {'value': '97', 'groupId': 'OG006'}, {'value': '31', 'groupId': 'OG007'}]}]}, {'title': 'Dryness-Mild (1)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Dryness-Moderate (2)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Dryness-Severe (3)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Edema-No Reaction (0)', 'categories': [{'measurements': [{'value': '101', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '96', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '97', 'groupId': 'OG004'}, {'value': '99', 'groupId': 'OG005'}, {'value': '97', 'groupId': 'OG006'}, {'value': '31', 'groupId': 'OG007'}]}]}, {'title': 'Edema-Mild (1)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Edema-Moderate (2)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Edema-Severe (3)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Erythema-No Reaction (0)', 'categories': [{'measurements': [{'value': '101', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '96', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '97', 'groupId': 'OG004'}, {'value': '96', 'groupId': 'OG005'}, {'value': '97', 'groupId': 'OG006'}, {'value': '30', 'groupId': 'OG007'}]}]}, {'title': 'Erythema-Mild (1)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}]}]}, {'title': 'Erythema-Moderate (2)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Erythema-Severe (3)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Rash-No Reaction (0)', 'categories': [{'measurements': [{'value': '101', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '96', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '97', 'groupId': 'OG004'}, {'value': '99', 'groupId': 'OG005'}, {'value': '97', 'groupId': 'OG006'}, {'value': '31', 'groupId': 'OG007'}]}]}, {'title': 'Rash-Mild (1)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Rash-Moderate (2)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Rash-Severe (3)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 hours post-treatment', 'description': 'Skin irritation rating (0-3) scores for dryness, edema, erythema and rash. 0 = no reaction, 1 = mild, 2 = moderate, 3 = severe. A skin irritation rating of 3 in any category represents significant irritation and qualifies as an adverse event.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '\\# sites treated (met inclusion/exclusion criteria including screening day baseline counts)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '3M CHG/IPA Prep Colorless Abdominal Region', 'description': 'Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator\n\n3M CHG/IPA Prep Colorless: Apply topically.'}, {'id': 'FG001', 'title': '3M CHG/IPA Prep Tint Abdominal Region', 'description': 'Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator\n\n3M CHG/IPA Prep Tint: Apply topically.'}, {'id': 'FG002', 'title': 'ChloraPrep CHG/IPA Hi-Lite Orange Tint Abdominal Region', 'description': 'Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator\n\nChloraPrep CHG/IPA Hi-Lite Orange Tint: Apply topically.'}, {'id': 'FG003', 'title': 'Normal Saline Abdominal Region', 'description': '0.9% normal saline with applicator\n\nNormal Saline: Apply topically.'}, {'id': 'FG004', 'title': '3M CHG/IPA Prep Colorless Inguinal Region', 'description': 'Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator\n\n3M CHG/IPA Prep Colorless: Apply topically.'}, {'id': 'FG005', 'title': '3M CHG/IPA Prep Tint Inguinal Region', 'description': 'Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator\n\n3M CHG/IPA Prep Colorless: Apply topically.'}, {'id': 'FG006', 'title': 'ChloraPrep CHG/IPA Hi-Lite Orange Tint Inguinal Region', 'description': 'Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator\n\nChloraPrep CHG/IPA Hi-Lite Orange Tint: Apply topically.'}, {'id': 'FG007', 'title': 'Normal Saline Inguinal Region', 'description': '0.9% normal saline with applicator\n\nNormal Saline: Apply topically.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '101', 'numSubjects': '101'}, {'groupId': 'FG001', 'numUnits': '93', 'numSubjects': '93'}, {'groupId': 'FG002', 'numUnits': '96', 'numSubjects': '96'}, {'groupId': 'FG003', 'numUnits': '32', 'numSubjects': '32'}, {'groupId': 'FG004', 'numUnits': '97', 'numSubjects': '97'}, {'groupId': 'FG005', 'numUnits': '99', 'numSubjects': '99'}, {'groupId': 'FG006', 'numUnits': '97', 'numSubjects': '97'}, {'groupId': 'FG007', 'numUnits': '31', 'numSubjects': '31'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '101', 'numSubjects': '101'}, {'groupId': 'FG001', 'numUnits': '93', 'numSubjects': '93'}, {'groupId': 'FG002', 'numUnits': '96', 'numSubjects': '96'}, {'groupId': 'FG003', 'numUnits': '32', 'numSubjects': '32'}, {'groupId': 'FG004', 'numUnits': '97', 'numSubjects': '97'}, {'groupId': 'FG005', 'numUnits': '99', 'numSubjects': '99'}, {'groupId': 'FG006', 'numUnits': '97', 'numSubjects': '97'}, {'groupId': 'FG007', 'numUnits': '31', 'numSubjects': '31'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG002', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG003', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG004', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG005', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG006', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG007', 'numUnits': '0', 'numSubjects': '0'}]}]}], 'typeUnitsAnalyzed': 'test sites on skin', 'preAssignmentDetails': 'This is a randomized, paired comparison design where each subject received 2 of the planned treatments, 1 on the left side and one on the right. Each subject provided 2 abdomen test sites, left \\& right and/or 2 inguen test sites, left \\& right.\n\n161 subjects were randomized for the abdomen region \\& 162 subjects randomized for the inguen region, resulting in 171 subjects providing 646 applications of test products on 2 anatomical regions.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}, {'value': '97', 'groupId': 'BG004'}, {'value': '99', 'groupId': 'BG005'}, {'value': '97', 'groupId': 'BG006'}, {'value': '31', 'groupId': 'BG007'}, {'value': '171', 'groupId': 'BG008'}]}, {'units': 'test sites on skin', 'counts': [{'value': '101', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}, {'value': '97', 'groupId': 'BG004'}, {'value': '99', 'groupId': 'BG005'}, {'value': '97', 'groupId': 'BG006'}, {'value': '31', 'groupId': 'BG007'}, {'value': '646', 'groupId': 'BG008'}]}], 'groups': [{'id': 'BG000', 'title': '3M CHG/IPA Prep Colorless Abdominal Region', 'description': 'Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator\n\n3M CHG/IPA Prep Colorless: Apply topically.'}, {'id': 'BG001', 'title': '3M CHG/IPA Prep Tint Abdominal Region', 'description': 'Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator\n\n3M CHG/IPA Prep Tint: Apply topically.'}, {'id': 'BG002', 'title': 'ChloraPrep CHG/IPA Hi-Lite Orange Tint Abdominal Region', 'description': 'Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator\n\nChloraPrep CHG/IPA Hi-Lite Orange Tint: Apply topically.'}, {'id': 'BG003', 'title': 'Normal Saline Abdominal Region', 'description': '0.9% normal saline with applicator\n\nNormal Saline: Apply topically.'}, {'id': 'BG004', 'title': '3M CHG/IPA Prep Colorless Inguinal Region', 'description': 'Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator\n\n3M CHG/IPA Prep Colorless: Apply topically.'}, {'id': 'BG005', 'title': '3M CHG/IPA Prep Tint Inguinal Region', 'description': 'Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator\n\n3M CHG/IPA Prep Colorless: Apply topically.'}, {'id': 'BG006', 'title': 'ChloraPrep CHG/IPA Hi-Lite Orange Tint Inguinal Region', 'description': 'Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator\n\nChloraPrep CHG/IPA Hi-Lite Orange Tint: Apply topically.'}, {'id': 'BG007', 'title': 'Normal Saline Inguinal Region', 'description': '0.9% normal saline with applicator\n\nNormal Saline: Apply topically.'}, {'id': 'BG008', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<=18 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}]}]}, {'title': 'Between 18 and 65 years', 'categories': [{'measurements': [{'value': '99', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}, {'value': '96', 'groupId': 'BG004'}, {'value': '96', 'groupId': 'BG005'}, {'value': '95', 'groupId': 'BG006'}, {'value': '31', 'groupId': 'BG007'}, {'value': '634', 'groupId': 'BG008'}]}]}, {'title': '>=66 years', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '12', 'groupId': 'BG008'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'test sites on skin', 'denomUnitsSelected': 'test sites on skin'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Sex : Female', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '31', 'groupId': 'BG004'}, {'value': '22', 'groupId': 'BG005'}, {'value': '21', 'groupId': 'BG006'}, {'value': '11', 'groupId': 'BG007'}, {'value': '170', 'groupId': 'BG008'}]}]}, {'title': 'Sex : Male', 'categories': [{'measurements': [{'value': '78', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '66', 'groupId': 'BG004'}, {'value': '77', 'groupId': 'BG005'}, {'value': '76', 'groupId': 'BG006'}, {'value': '20', 'groupId': 'BG007'}, {'value': '476', 'groupId': 'BG008'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'test sites on skin', 'denomUnitsSelected': 'test sites on skin'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '88', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}, {'value': '84', 'groupId': 'BG004'}, {'value': '88', 'groupId': 'BG005'}, {'value': '85', 'groupId': 'BG006'}, {'value': '25', 'groupId': 'BG007'}, {'value': '564', 'groupId': 'BG008'}]}]}, {'title': 'Hispanic/Latino', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '18', 'groupId': 'BG008'}]}]}, {'title': 'Black or Africian American', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '12', 'groupId': 'BG008'}]}]}, {'title': 'Native Hawaiian or other Pacific Islander', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '8', 'groupId': 'BG008'}]}]}, {'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '22', 'groupId': 'BG008'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '12', 'groupId': 'BG008'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '10', 'groupId': 'BG008'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'test sites on skin', 'denomUnitsSelected': 'test sites on skin'}], 'typeUnitsAnalyzed': 'test sites on skin', 'populationDescription': 'Subjects with average screening day baseline counts of \\> or equal to 3.00 log10 CFU/cm2 bilaterally on the abdominal region and/or \\> or equal to 5.00 log10 CFU/cm2 bilaterally on the inguinal region were to be included in the efficacy analysis. However, due to early study termination the primary efficacy endpoint analysis was not performed. The 171 subjects who provided 646 test sites on skin for product application on the 2 anatomical regions were included in the safety analyses.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 171}}, 'statusModule': {'whyStopped': 'Study discontinued due to data quality issues.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'dispFirstSubmitDate': '2015-03-25', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-30', 'studyFirstSubmitDate': '2013-10-21', 'dispFirstSubmitQcDate': '2015-03-25', 'resultsFirstSubmitDate': '2019-03-09', 'studyFirstSubmitQcDate': '2013-10-21', 'dispFirstPostDateStruct': {'date': '2015-04-15', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2024-10-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-07-12', 'studyFirstPostDateStruct': {'date': '2013-10-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Responder Rate', 'timeFrame': 'baseline, 10 minute post-product application and 6 hour post-product application', 'description': 'On the abdominal region a responder was a subject with a 2-log10/cm2 bacterial reduction at 10 minutes and for whom the skin flora did not return to baseline at 6 hours.\n\nOn the inguinal region a responder was a subject with a 3-log10/cm2 bacterial reduction at 10 minutes and for whom the skin flora did not return to baseline at 6 hours.'}, {'measure': 'Skin Flora Baseline for Abdominal and Inguinal Regions', 'timeFrame': 'Baseline', 'description': 'Log10/cm2 baseline skin flora for abdominal and inguinal regions'}, {'measure': 'Skin Flora Recovery Post-treatment', 'timeFrame': '10 minutes and 6 hours post-treatment', 'description': 'Log10/cm2 recovery of skin flora at 10 minutes and 6 hours following application of study treatments for abdominal and inguinal regions'}, {'measure': 'Reduction of Skin Flora Post-treatment', 'timeFrame': 'Baseline, 10 minutes and 6 hours', 'description': 'Log10/cm2 reduction of skin flora, relative to Treatment Day baseline log10/cm2, at 10 minutes and 6 hours'}], 'secondaryOutcomes': [{'measure': 'Safety as Assessed by Skin Irritation Scores', 'timeFrame': 'Baseline', 'description': 'Skin irritation rating (0-3) scores for dryness, edema, erythema and rash. 0 = no reaction, 1 = mild, 2 = moderate, 3 = severe. A skin irritation rating of 3 in any category represents significant irritation and qualifies as an adverse event.'}, {'measure': 'Safety as Assessed by Skin Irritation Scores', 'timeFrame': '10 minutes post-treatment', 'description': 'Skin irritation rating (0-3) scores for dryness, edema, erythema and rash. 0 = no reaction, 1 = mild, 2 = moderate, 3 = severe. A skin irritation rating of 3 in any category represents significant irritation and qualifies as an adverse event.'}, {'measure': 'Safety as Assessed by Skin Irritation Scores', 'timeFrame': '6 hours post-treatment', 'description': 'Skin irritation rating (0-3) scores for dryness, edema, erythema and rash. 0 = no reaction, 1 = mild, 2 = moderate, 3 = severe. A skin irritation rating of 3 in any category represents significant irritation and qualifies as an adverse event.'}]}, 'conditionsModule': {'keywords': ['surgical skin prep', 'CHG', 'IPA'], 'conditions': ['Skin Flora Bacterial Reduction Post-product Application']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the antimicrobial efficacy of the 3M CHG/IPA Prep on skin flora of the abdominal and inguinal regions of human subjects.', 'detailedDescription': 'The primary efficacy is evaluated by demonstration that the product provides a lower bound of the 95% confidence interval of percent responders that is greater than or equal to 70%. On the abdominal sites, a responder is defined as a subject with a 2-log10 per cm2 bacterial reduction at 10 minutes and for whom the skin flora does not return to baseline at 6 hours. On the inguinal sites, a responder is defined as a subject with a 3-log10 per cm2 bacterial reduction at 10 minutes and for whom the skin flora does not return to baseline at 6 hours.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects of any race\n* Subjects in good general health\n* Minimum skin flora baseline requirements on abdomen and groin\n\nExclusion Criteria:\n\n* Any tattoos, scars, breaks in the skin, or any form of dermatitis, or other skin disorders (including acne) on the applicable test areas\n* Topical antimicrobial exposure within 14 days prior to screening and treatment days\n* Use of systemic or topical antibiotics, steroid medications, or any other products known to affect the normal microbial flora of the skin within 14 days prior to screening and treatment days'}, 'identificationModule': {'nctId': 'NCT01968356', 'briefTitle': 'In-vivo Efficacy Study of Patient Preoperative Preps', 'organization': {'class': 'INDUSTRY', 'fullName': 'Solventum US LLC'}, 'officialTitle': 'Assessment of the Antimicrobial Efficacy of 3M CHG/IPA Preoperative Skin Preparation Against Resident Human Skin Flora on the Abdominal and Inguinal Regions', 'orgStudyIdInfo': {'id': 'EM-012759'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '3M CHG/IPA Prep Colorless', 'description': 'Applied topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.', 'interventionNames': ['Drug: 3M CHG/IPA Prep Colorless']}, {'type': 'EXPERIMENTAL', 'label': '3M CHG/IPA Prep Tint', 'description': 'Applied topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.', 'interventionNames': ['Drug: 3M CHG/IPA Prep Tint']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ChloraPrep Hi-Lite Orange', 'description': 'Applied topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.', 'interventionNames': ['Drug: ChloraPrep']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Normal Saline', 'description': 'Applied topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.', 'interventionNames': ['Drug: Saline']}], 'interventions': [{'name': '3M CHG/IPA Prep Colorless', 'type': 'DRUG', 'otherNames': ['Chlorhexidine glucontate and Isopropyl alcohol', 'CHG 2% / IPA 70%', 'Chlorhexidine gluconate 2% / Isopropyl alcohol 70%'], 'description': 'Apply topically.', 'armGroupLabels': ['3M CHG/IPA Prep Colorless']}, {'name': '3M CHG/IPA Prep Tint', 'type': 'DRUG', 'otherNames': ['Chlorhexidine glucontate and Isopropyl alcohol', 'CHG 2%/IPA 70%', 'Chlorhexidine gluconate 2% / Isopropyl alcohol 70%'], 'description': 'Apply topically.', 'armGroupLabels': ['3M CHG/IPA Prep Tint']}, {'name': 'ChloraPrep', 'type': 'DRUG', 'otherNames': ['ChloraPrep One-Step', 'ChloraPrep Patient Preoperative Skin Preparation', '2% CHG/70% IPA', 'Chlorhexidine glucontate and Isopropyl alcohol', 'Chlorhexidine gluconate 2% / Isopropyl alcohol 70%'], 'description': 'Apply topically.', 'armGroupLabels': ['ChloraPrep Hi-Lite Orange']}, {'name': 'Saline', 'type': 'DRUG', 'otherNames': ['0.9% NaCl', 'Normal Saline'], 'description': 'Apply topically.', 'armGroupLabels': ['Normal Saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59718', 'city': 'Bozeman', 'state': 'Montana', 'country': 'United States', 'facility': 'BioScience Laboratories, Inc.', 'geoPoint': {'lat': 45.67965, 'lon': -111.03856}}], 'overallOfficials': [{'name': 'Robert R McCormack, BS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'BioScience Laboratories, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Solventum US LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': '3M', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}