Ignite Creation Date:
2025-12-26 @ 5:24 PM
Ignite Modification Date:
2025-12-26 @ 5:24 PM
Study NCT ID:
NCT01330706
Status:
COMPLETED
Last Update Posted:
2011-04-07
First Post:
2011-04-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Intraoperative Surgical Scrubbing in Reducing Bacterial Load After Nail Removal Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2011-08-05', 'releaseDate': '2011-07-12'}, {'resetDate': '2011-09-09', 'releaseDate': '2011-08-09'}, {'resetDate': '2011-10-25', 'releaseDate': '2011-09-19'}], 'estimatedResultsFirstSubmitDate': '2011-07-12'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D009260', 'term': 'Nail Diseases'}, {'id': 'D009263', 'term': 'Nails, Ingrown'}], 'ancestors': [{'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C031233', 'term': 'polihexanide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-02', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-04-06', 'studyFirstSubmitDate': '2011-04-01', 'studyFirstSubmitQcDate': '2011-04-06', 'lastUpdatePostDateStruct': {'date': '2011-04-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-04-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'bacterial count (CFU/cm2)', 'timeFrame': 'Participants will be followed until the surgery to heal completely,an expected average of 7 weeks', 'description': 'The percentage of inoculum reduction at the irrigation step was calculated as follows: percentage of inoculum reduction = 100 e (1003 Ii)/Is, where Ii is the bacterial count (CFU/cm2) at the irrigation step and Is is the inoculum (CFU/cm2) at the surgery step.\n\nBacteria were identified using standard laboratory methods. The limit of detection in the nailfold test was 1.33 CFU/cm2.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Skin Diseases [C17.800]', 'Nail Diseases [C17.800.529]', 'Nails, Ingrown [C17.800.529.406]'], 'conditions': ['Skin Diseases', 'Nail Diseases', 'Nails, Ingrown']}, 'referencesModule': {'references': [{'pmid': '21112671', 'type': 'BACKGROUND', 'citation': 'Becerro de Bengoa Vallejo R, Losa Iglesias ME, Cervera LA, Fernandez DS, Prieto JP. Efficacy of intraoperative surgical irrigation with polihexanide and nitrofurazone in reducing bacterial load after nail removal surgery. J Am Acad Dermatol. 2011 Feb;64(2):328-35. doi: 10.1016/j.jaad.2010.01.011. Epub 2010 Nov 26.'}], 'seeAlsoLinks': [{'url': 'http://www.ucm.es', 'label': 'University Complutense de Madrid'}]}, 'descriptionModule': {'briefSummary': 'The investigators conducted a controlled, prospective randomized study to examine the antiseptic efficacy of intraoperative irrigation methods during nail avulsion surgery.', 'detailedDescription': 'The investigators conducted a controlled, prospective randomized study to examine the antiseptic efficacy of intraoperative scrubbing methods during nail avulsion surgery. The investigators compared intraoperative antiseptic scrubbing using 0.9% saline solution and 0.1% polihexanide. Swab samples were taken from each patient at 5 distinct stages throughout the surgical procedure, and bacterial culture analysis was performed (positive culture rate, total inocula count, reduction of bacterial load, and identification of specific microorganisms).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Older than 18\n* Onychocryptosis\n\nExclusion Criteria:\n\n* infection\n* a history of tinea pedis\n* onychomycosis\n* paronychia\n* nail trauma or subungual hematoma\n* nail deformities and disorders\n* peripheral vascular disease or diabetes\n* cardiac disease\n* a history of rheumatic fever\n* recent antibiotic use or current antimicrobial therapy\n* a history of steroid use and\n* recent nail polish use'}, 'identificationModule': {'nctId': 'NCT01330706', 'acronym': 'ribebeva', 'briefTitle': 'Efficacy of Intraoperative Surgical Scrubbing in Reducing Bacterial Load After Nail Removal Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Complutense de Madrid'}, 'officialTitle': 'Efficacy of Intraoperative Surgical Scrubbing in Reducing Bacterial Load After Nail Removal Surgery', 'orgStudyIdInfo': {'id': 'UCM 2011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sterile Saline solution', 'description': 'The investigators compared intraoperative antiseptic irrigation using 0.9% saline solution and 0.1% polihexanide.', 'interventionNames': ['Drug: Polihexanide']}], 'interventions': [{'name': 'Polihexanide', 'type': 'DRUG', 'description': 'The investigators compared intraoperative antiseptic irrigation using 0.9% saline solution and 0.1% polihexanide.', 'armGroupLabels': ['Sterile Saline solution']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28040', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Universidad Complutense de Madrid', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Ricado Becerro de Bengoa Vallejo, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad Complutense de Madrid'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Complutense de Madrid', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Ricardo Becerro de Bengoa Vallejo', 'oldOrganization': 'Universidad Complutense de Madrid'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2011-07-12', 'type': 'RELEASE'}, {'date': '2011-08-05', 'type': 'RESET'}, {'date': '2011-08-09', 'type': 'RELEASE'}, {'date': '2011-09-09', 'type': 'RESET'}, {'date': '2011-09-19', 'type': 'RELEASE'}, {'date': '2011-10-25', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Ricardo Becerro de Bengoa Vallejo, Profesor Titular de Universidad, Universidad Complutense de Madrid'}}}}