Ignite Creation Date:
2025-12-24 @ 3:50 PM
Ignite Modification Date:
2025-12-28 @ 11:47 AM
Study NCT ID:
NCT01926392
Status:
COMPLETED
Last Update Posted:
2013-08-21
First Post:
2013-08-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of a Water-soluble Topical Antimicrobial to Silver Sulfadiazine in Partial Thickness Burns
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002056', 'term': 'Burns'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012837', 'term': 'Silver Sulfadiazine'}], 'ancestors': [{'id': 'D013411', 'term': 'Sulfadiazine'}, {'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013424', 'term': 'Sulfanilamides'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-20', 'studyFirstSubmitDate': '2013-08-17', 'studyFirstSubmitQcDate': '2013-08-17', 'lastUpdatePostDateStruct': {'date': '2013-08-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-08-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'narcotic medication administered', 'timeFrame': '180 minutes', 'description': 'All narcotics given for premedication and during the dressing change will be converted to their morphine-equivalent and totaled'}], 'primaryOutcomes': [{'measure': 'Pain level', 'timeFrame': '180 minutes', 'description': "Pain is assessed on a 0-10 point scale using both the patient's reported value and correlating with the value derived from nursing assessment using the visual analog scale. This is recorded at defined time points before, during, and after the dressing change"}], 'secondaryOutcomes': [{'measure': 'time to perform dressing changes', 'timeFrame': 'up to 180 minutes', 'description': 'The time to perform the dressing change in total and for various steps is recorded in minutes.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Burn']}, 'descriptionModule': {'briefSummary': 'Partial thickness burns are a common, painful injury requiring a great deal of resources in their care. Silver sulfadizine is a commonly-used topical antimicrobial, but is difficult to remove due to its lipid base. We are comparing a water-based topical antimicrobial therapy to silver sulfadiazine and hypothesize that the water-based therapy is superior in terms of pain control and resources required to deliver care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult inpatients with partial thickness burns\n\nExclusion Criteria:\n\n* superficial or full thickness burns, facial burns, intubated or sedated, pediatric'}, 'identificationModule': {'nctId': 'NCT01926392', 'briefTitle': 'Comparison of a Water-soluble Topical Antimicrobial to Silver Sulfadiazine in Partial Thickness Burns', 'organization': {'class': 'OTHER', 'fullName': 'University of Virginia'}, 'officialTitle': 'A Prospective Randomized Trial Comparing Silver Sulfadiazine Cream to a Water-Soluble Poly-Antimicrobial Gel in Partial Thickness Burn Wounds', 'orgStudyIdInfo': {'id': '15603'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'water-soluble therapy', 'description': 'The patient acted as their own control and the experimental and comparison arms (water-soluble therapy and silver sulfadiazine) were alternated on a daily basis', 'interventionNames': ['Drug: water-soluble therapy', 'Drug: silver sulfadiazine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'silver sulfadiazine', 'description': 'The patient acted as their own control and the experimental and comparison arms (water-soluble therapy and silver sulfadiazine) were alternated on a daily basis', 'interventionNames': ['Drug: water-soluble therapy', 'Drug: silver sulfadiazine']}], 'interventions': [{'name': 'water-soluble therapy', 'type': 'DRUG', 'description': 'The patient acted as their own control and the experimental and comparison arms (water-soluble therapy and silver sulfadiazine) were alternated on a daily basis', 'armGroupLabels': ['silver sulfadiazine', 'water-soluble therapy']}, {'name': 'silver sulfadiazine', 'type': 'DRUG', 'description': 'The patient acted as their own control and the experimental and comparison arms (water-soluble therapy and silver sulfadiazine) were alternated on a daily basis', 'armGroupLabels': ['silver sulfadiazine', 'water-soluble therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22908', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'University of Virginia Health System', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}], 'overallOfficials': [{'name': 'Jonathan Black, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Virginia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Virginia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}