Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2026-04-15 @ 9:30 AM
Study NCT ID:
NCT01981460
Status:
COMPLETED
Last Update Posted:
2013-11-11
First Post:
2013-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PhotoDynamic Therapy for Line Infection Prevention (PLIP): Pilot Study on Healthy Volunteers.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008751', 'term': 'Methylene Blue'}], 'ancestors': [{'id': 'D010640', 'term': 'Phenothiazines'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-08', 'studyFirstSubmitDate': '2013-11-05', 'studyFirstSubmitQcDate': '2013-11-08', 'lastUpdatePostDateStruct': {'date': '2013-11-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of the skin microbiome after methylene blue treatment', 'timeFrame': '1 week', 'description': 'We compared the two arms of each subject --one arm treated with chloraprep and a biopatch \\[routine treatment of skin\\] to the routine treatment with the addition of methylene blue spray and light activation. The microbiome of both skin areas were assessed before and after the routine treatment and the treatment with the addition of methylene blue therapy;'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Light; Therapy, Complications']}, 'descriptionModule': {'briefSummary': 'We are evaluating the effect of methylene blue and visible light activation on the microbiome of the skin.', 'detailedDescription': 'Antiseptics are routinely utilized to prevent infections of vascular catheters. We are evaluating the addition of methylene blue and light activation on skin to determine whether this inexpensive and non-toxic treatment can decrease skin pathogens and prevent blood stream infections of long-term vascular catheters. This is a pilot study of normal volunteers to determine the effect on the microbiome of the addition of methylene blue and light activation on antiseptic-treated skin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Normal individuals without skin problems\n\nExclusion Criteria:\n\n* Smokers\n* Diabetics\n* Atopic dermatitis\n* G-6-PD deficiency\n* Eczema\n* Other skin conditions\n* Allergies to methylene blue or chlorhexadine'}, 'identificationModule': {'nctId': 'NCT01981460', 'briefTitle': 'PhotoDynamic Therapy for Line Infection Prevention (PLIP): Pilot Study on Healthy Volunteers.', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'PhotoDynamic Therapy for Line Infection Prevention (PLIP): Pilot Study on Normal Volunteers', 'orgStudyIdInfo': {'id': '2012P-002692'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Chloroprep and biopatch', 'description': 'Both arms are cleaned with chloroprep and a biopatch is placed on each arm.'}, {'type': 'EXPERIMENTAL', 'label': 'Methylene blue and light treatment', 'description': 'Methylene blue and light treatment for 17 minutes are done twice over 1 week intervals.', 'interventionNames': ['Procedure: Methylene blue and light treatment']}], 'interventions': [{'name': 'Methylene blue and light treatment', 'type': 'PROCEDURE', 'description': 'Methylene blue and light treatment for 17 minutes are done twice over 1 week intervals.', 'armGroupLabels': ['Methylene blue and light treatment']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jeanine Wiener-Kronish, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MGH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief of Anesthesia', 'investigatorFullName': 'Jeanine Wiener-Kronish', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}