Ignite Creation Date:
2025-12-24 @ 6:32 PM
Ignite Modification Date:
2026-02-22 @ 4:14 PM
Study NCT ID:
NCT00692757
Status:
UNKNOWN
Last Update Posted:
2008-10-21
First Post:
2008-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Wound Antiseptic Study With Hypochlorous Acid & Iodopovidone
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013530', 'term': 'Surgical Wound Infection'}, {'id': 'D003428', 'term': 'Cross Infection'}], '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': 'D007049', 'term': 'Iatrogenic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006997', 'term': 'Hypochlorous Acid'}, {'id': 'D011206', 'term': 'Povidone-Iodine'}], 'ancestors': [{'id': 'D000148', 'term': 'Acids, Noncarboxylic'}, {'id': 'D000143', 'term': 'Acids'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D017382', 'term': 'Reactive Oxygen Species'}, {'id': 'D005609', 'term': 'Free Radicals'}, {'id': 'D010087', 'term': 'Oxides'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}, {'id': 'D007466', 'term': 'Iodophors'}, {'id': 'D017613', 'term': 'Iodine Compounds'}, {'id': 'D011145', 'term': 'Polyvinyls'}, {'id': 'D014753', 'term': 'Vinyl Compounds'}, {'id': 'D000475', 'term': 'Alkenes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011205', 'term': 'Povidone'}, {'id': 'D011760', 'term': 'Pyrrolidinones'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010969', 'term': 'Plastics'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 432}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-10', 'completionDateStruct': {'date': '2009-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2008-10-20', 'studyFirstSubmitDate': '2008-06-03', 'studyFirstSubmitQcDate': '2008-06-05', 'lastUpdatePostDateStruct': {'date': '2008-10-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Surgical site infection rates', 'timeFrame': 'until one month (weekly)'}], 'secondaryOutcomes': [{'measure': 'Decreasing Colony Forming Unit count (CFU/mL) after using the skin topic antiseptic in surgical site', 'timeFrame': 'one week'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Hypochlorous Acid', 'Colony forming units', 'surgical site infection', 'nosocomial infection', 'bacterial bioburden', 'wound healing'], 'conditions': ['Surgical Site Infection']}, 'referencesModule': {'references': [{'pmid': '16669304', 'type': 'BACKGROUND', 'citation': 'Selkon JB, Cherry GW, Wilson JM, Hughes MA. Evaluation of hypochlorous acid washes in the treatment of chronic venous leg ulcers. J Wound Care. 2006 Jan;15(1):33-7. doi: 10.12968/jowc.2006.15.1.26861.'}, {'pmid': '17492051', 'type': 'BACKGROUND', 'citation': 'Robson MC, Payne WG, Ko F, Mentis M, Donati G, Shafii SM, Culverhouse S, Wang L, Khosrovi B, Najafi R, Cooper DM, Bassiri M. Hypochlorous Acid as a Potential Wound Care Agent: Part II. Stabilized Hypochlorous Acid: Its Role in Decreasing Tissue Bacterial Bioburden and Overcoming the Inhibition of Infection on Wound Healing. J Burns Wounds. 2007 Apr 11;6:e6.'}, {'pmid': '17492050', 'type': 'BACKGROUND', 'citation': 'Wang L, Bassiri M, Najafi R, Najafi K, Yang J, Khosrovi B, Hwong W, Barati E, Belisle B, Celeri C, Robson MC. Hypochlorous acid as a potential wound care agent: part I. Stabilized hypochlorous acid: a component of the inorganic armamentarium of innate immunity. J Burns Wounds. 2007 Apr 11;6:e5.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether hypochlorous acid is an effective antiseptic agent to prevent surgical site infection.', 'detailedDescription': "A topical antimicrobial that decrease the bacterial bioburden of surgical wounds without impairing the wound's ability to heal is a need. A stabilized form of hypochlorous acid has been demonstrated in vitro and in animal studies to possess properties that could fulfill these criteria but it is imperative to assess its efficacy and safety in humans.\n\nTo assess hypochlorous acid efficacy and safety, it was designed a clinical controlled randomized trial to compare hypochlorous acid to iodopovidone, the gold standard, in preoperative scrub of surgical area."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients over 18 years old, who are going to be operated\n* Classification of surgical wounds according to the National Research Council as class I or II\n* Risk index classification of the American Society of Anaesthesiology (ASA) as ASA 1 or 2\n\nExclusion Criteria:\n\n* Patients requiring mesh or prosthesis or orthesis'}, 'identificationModule': {'nctId': 'NCT00692757', 'acronym': 'WASH', 'briefTitle': 'Wound Antiseptic Study With Hypochlorous Acid & Iodopovidone', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Tecnológica de Pereira'}, 'officialTitle': 'Comparative Study of Two Antiseptics Solutions for the Prevention of Surgical Site Infection', 'orgStudyIdInfo': {'id': '5-07-9'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'Hypochlorous acid', 'interventionNames': ['Drug: Hypochlorous acid']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B', 'description': 'Iodopovidone', 'interventionNames': ['Drug: Iodopovidone']}], 'interventions': [{'name': 'Hypochlorous acid', 'type': 'DRUG', 'otherNames': ['NVC-101 NovaBay Pharmaceuticals, Inc, Emeryville, CA'], 'description': 'Hypochlorous acid for preoperative scrubbing to prevent surgical site infection in spray', 'armGroupLabels': ['A']}, {'name': 'Iodopovidone', 'type': 'DRUG', 'description': 'Iodopovidone', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Pereira', 'state': 'Risaralda Department', 'status': 'RECRUITING', 'country': 'Colombia', 'contacts': [{'name': 'Rodolfo A Cabrales, MD.', 'role': 'CONTACT', 'email': 'rocabster@gmail.com', 'phone': '57-6-333-0014'}, {'name': 'German A Moreno, MD.,MSc', 'role': 'CONTACT', 'email': 'gamo@cable.net.co', 'phone': '57-6-333-7126'}, {'name': 'Rodolfo A Cabrales, MD.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hospital Universitario San Jorge (HUSJ)', 'geoPoint': {'lat': 4.81428, 'lon': -75.69488}}], 'centralContacts': [{'name': 'Juliana Buitrago, Master', 'role': 'CONTACT', 'email': 'julianabuitrago@yahoo.com', 'phone': '313-649-0439'}], 'overallOfficials': [{'name': 'Juliana Buitrago, MD.,MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad Tecnológica de Pereira'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Tecnológica de Pereira', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospital Universitario San Jorge de Pereira (HUSJ)', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'Juliana Buitrago Jaramillo', 'oldOrganization': 'Universidad Tecnológica de Pereira'}}}}