Back to resultsEffectiveness of Topical Glycerine Sulphate Paste, Hirudoid Cream and Nil Application on Superficial Phlebitis
Primary Purpose
Infection
Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Glycerine Magnesium sulphate paste
Mucopolysaccharide polysulphate
No application
Sponsored by
About this trial
This is an interventional treatment trial for Infection focused on measuring superficial phlebitis, cannula-related vein inflammation, Glycerine magnesium sulphate, Hirudoid cream, Nursing
Eligibility Criteria
Inclusion Criteria:
- Patients admitted to the study institution between Dec 2009 and Feb 2010 and observed to develop redness associated with peripheral infusion cannula.
Exclusion Criteria:
- Thrombosis, poor skin condition, and pus seen at the previous puncture.
Sites / Locations
- Tan Tock Seng Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Experimental
Arm Label
Glycerine Magnesium Sulphate paste
Hirudoid cream
No application
Arm Description
Topical Mucopolysaccharide polysulphate
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.
Outcomes
Primary Outcome Measures
Erythema size
The incremental percentage change in erythema size
Secondary Outcome Measures
Time to resolve redness
The rate of phlebitis resolution
Full Information
NCT ID
NCT01226069
First Posted
October 20, 2010
Last Updated
October 20, 2010
Sponsor
Tan Tock Seng Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01226069
Brief Title
Effectiveness of Topical Glycerine Sulphate Paste, Hirudoid Cream and Nil Application on Superficial Phlebitis
Official Title
To Investigate the Effectiveness of Topical Glycerine Sulphate, Hirudoid Cream and Nil Application in Treating Peripheral Cannula Related Phlebitis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Tan Tock Seng Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of the interventional study is to compare the different treatment modalities in reducing erythema size and rate of resolving phlebitis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection
Keywords
superficial phlebitis, cannula-related vein inflammation, Glycerine magnesium sulphate, Hirudoid cream, Nursing
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
147 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Glycerine Magnesium Sulphate paste
Arm Type
Active Comparator
Arm Title
Hirudoid cream
Arm Type
Active Comparator
Arm Description
Topical Mucopolysaccharide polysulphate
Arm Title
No application
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Glycerine Magnesium sulphate paste
Intervention Description
Dosage to apply adheres to the manufacturer's recommendation. Sufficient amount should cover the erythema size. Dose frequency is 12 hourly.
Intervention Type
Drug
Intervention Name(s)
Mucopolysaccharide polysulphate
Intervention Description
Dosage to apply adheres to the manufacturer's recommendation. Sufficient amount should cover the erythema size. Dose frequency is 12 hourly.
Intervention Type
Other
Intervention Name(s)
No application
Intervention Description
No application
Primary Outcome Measure Information:
Title
Erythema size
Description
The incremental percentage change in erythema size
Time Frame
5 days
Secondary Outcome Measure Information:
Title
Time to resolve redness
Description
The rate of phlebitis resolution
Time Frame
5 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients admitted to the study institution between Dec 2009 and Feb 2010 and observed to develop redness associated with peripheral infusion cannula.
Exclusion Criteria:
Thrombosis, poor skin condition, and pus seen at the previous puncture.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isabel Ng, MSc Epidemiology
Organizational Affiliation
Tan Tock Seng Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tan Tock Seng Hospital
City
Singapore
ZIP/Postal Code
308433
Country
Singapore
12. IPD Sharing Statement
Citations:
PubMed Identifier
19289920
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.
Results Reference
result
PubMed Identifier
8256008
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.
Results Reference
result
PubMed Identifier
14525568
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.
Results Reference
result
PubMed Identifier
12544367
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.
Results Reference
result
PubMed Identifier
10192751
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.
Results Reference
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.
Results Reference
result
Learn more about this trial
Effectiveness of Topical Glycerine Sulphate Paste, Hirudoid Cream and Nil Application on Superficial Phlebitis
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