Ignite Creation Date:
2025-12-24 @ 11:02 PM
Ignite Modification Date:
2026-01-05 @ 1:34 PM
Study NCT ID:
NCT01226069
Status:
COMPLETED
Last Update Posted:
2010-10-21
First Post:
2010-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Topical Glycerine Sulphate Paste, Hirudoid Cream and Nil Application on Superficial Phlebitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 147}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-10', 'completionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-10-20', 'studyFirstSubmitDate': '2010-10-20', 'studyFirstSubmitQcDate': '2010-10-20', 'lastUpdatePostDateStruct': {'date': '2010-10-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Erythema size', 'timeFrame': '5 days', 'description': 'The incremental percentage change in erythema size'}], 'secondaryOutcomes': [{'measure': 'Time to resolve redness', 'timeFrame': '5 days', 'description': 'The rate of phlebitis resolution'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['superficial phlebitis', 'cannula-related vein inflammation', 'Glycerine magnesium sulphate', 'Hirudoid cream', 'Nursing'], 'conditions': ['Infection']}, 'referencesModule': {'references': [{'pmid': '19289920', 'type': 'RESULT', 'citation': 'dos Reis PE, Silveira RC, Vasques CI, de Carvalho EC. Pharmacological interventions to treat phlebitis: systematic review. J Infus Nurs. 2009 Mar-Apr;32(2):74-9. doi: 10.1097/NAN.0b013e318198d497.'}, {'pmid': '8256008', 'type': 'RESULT', 'citation': 'Almenar L, Hernandez M, Gimeno JV, Palencia M, Algarra F. [Heparinoids versus nitroglycerin in the treatment of superficial phlebitis]. Rev Clin Esp. 1993 Oct;193(5):229-31. Spanish.'}, {'pmid': '14525568', 'type': 'RESULT', 'citation': 'Cokmez A, Gur S, Genc H, Deniz S, Tarcan E. Effect of transdermal glyceryl trinitrate and anti-inflammatory gel in infusion phlebitis. ANZ J Surg. 2003 Oct;73(10):794-6. doi: 10.1046/j.1445-2197.2003.02791.x.'}, {'pmid': '12544367', 'type': 'RESULT', 'citation': 'Gouping Z, Wan-Er T, Xue-Ling W, Min-Qian X, Kun F, Turale S, Fisher JW. Notoginseny cream in the treatment of phlebitis. J Infus Nurs. 2003 Jan-Feb;26(1):49-54. doi: 10.1097/00129804-200301000-00007.'}, {'pmid': '10192751', 'type': 'RESULT', 'citation': 'Vilardell M, Sabat D, Arnaiz JA, Bleda MJ, Castel JM, Laporte JR, Vallve C. Topical heparin for the treatment of acute superficial phlebitis secondary to indwelling intravenous catheter. A double-blind, randomized, placebo-controlled trial. Eur J Clin Pharmacol. 1999 Feb;54(12):917-21. doi: 10.1007/s002280050575.'}, {'type': 'RESULT', 'citation': 'Gua H, Li Y-J, Ma H-J. Efficacy observation of glycerine magnesium sulphate emulsion on the treatment of phlebitis. Journal of Lanzhou University (Medical Sciences). 2007;33(2):67-69.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the interventional study is to compare the different treatment modalities in reducing erythema size and rate of resolving phlebitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients admitted to the study institution between Dec 2009 and Feb 2010 and observed to develop redness associated with peripheral infusion cannula.\n\nExclusion Criteria:\n\n* Thrombosis, poor skin condition, and pus seen at the previous puncture.'}, 'identificationModule': {'nctId': 'NCT01226069', 'briefTitle': 'Effectiveness of Topical Glycerine Sulphate Paste, Hirudoid Cream and Nil Application on Superficial Phlebitis', 'organization': {'class': 'OTHER', 'fullName': 'Tan Tock Seng Hospital'}, 'officialTitle': 'To Investigate the Effectiveness of Topical Glycerine Sulphate, Hirudoid Cream and Nil Application in Treating Peripheral Cannula Related Phlebitis', 'orgStudyIdInfo': {'id': 'D/09/481'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Glycerine Magnesium Sulphate paste', 'interventionNames': ['Drug: Glycerine Magnesium sulphate paste']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Hirudoid cream', 'description': 'Topical Mucopolysaccharide polysulphate', 'interventionNames': ['Drug: Mucopolysaccharide polysulphate']}, {'type': 'EXPERIMENTAL', 'label': 'No application', 'description': 'Patient will not receive any topical application to apply on the phlebitis site. The outcome assessor will monitor regularly at pre-determined schedule as patients in other active arms.', 'interventionNames': ['Other: No application']}], 'interventions': [{'name': 'Glycerine Magnesium sulphate paste', 'type': 'DRUG', 'description': "Dosage to apply adheres to the manufacturer's recommendation. Sufficient amount should cover the erythema size. Dose frequency is 12 hourly.", 'armGroupLabels': ['Glycerine Magnesium Sulphate paste']}, {'name': 'Mucopolysaccharide polysulphate', 'type': 'DRUG', 'description': "Dosage to apply adheres to the manufacturer's recommendation. Sufficient amount should cover the erythema size. Dose frequency is 12 hourly.", 'armGroupLabels': ['Hirudoid cream']}, {'name': 'No application', 'type': 'OTHER', 'description': 'No application', 'armGroupLabels': ['No application']}]}, 'contactsLocationsModule': {'locations': [{'zip': '308433', 'city': 'Singapore', 'state': 'Singapore', 'country': 'Singapore', 'facility': 'Tan Tock Seng Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'overallOfficials': [{'name': 'Isabel Ng, MSc Epidemiology', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tan Tock Seng Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tan Tock Seng Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Isabel Ng Hui Leng', 'oldOrganization': 'Tan Tock Seng Hospital'}}}}