- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01226069
Effectiveness of Topical Glycerine Sulphate Paste, Hirudoid Cream and Nil Application on Superficial Phlebitis
October 20, 2010 updated by: Tan Tock Seng Hospital
To Investigate the Effectiveness of Topical Glycerine Sulphate, Hirudoid Cream and Nil Application in Treating Peripheral Cannula Related Phlebitis
The aim of the interventional study is to compare the different treatment modalities in reducing erythema size and rate of resolving phlebitis.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
147
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Singapore, Singapore, 308433
- Tan Tock Seng Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Glycerine Magnesium Sulphate paste
|
Dosage to apply adheres to the manufacturer's recommendation.
Sufficient amount should cover the erythema size.
Dose frequency is 12 hourly.
|
Active Comparator: Hirudoid cream
Topical Mucopolysaccharide polysulphate
|
Dosage to apply adheres to the manufacturer's recommendation.
Sufficient amount should cover the erythema size.
Dose frequency is 12 hourly.
|
Experimental: No application
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.
|
No application
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Erythema size
Time Frame: 5 days
|
The incremental percentage change in erythema size
|
5 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to resolve redness
Time Frame: 5 days
|
The rate of phlebitis resolution
|
5 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Isabel Ng, MSc Epidemiology, Tan Tock Seng Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2009
Primary Completion (Actual)
February 1, 2010
Study Completion (Actual)
February 1, 2010
Study Registration Dates
First Submitted
October 20, 2010
First Submitted That Met QC Criteria
October 20, 2010
First Posted (Estimate)
October 21, 2010
Study Record Updates
Last Update Posted (Estimate)
October 21, 2010
Last Update Submitted That Met QC Criteria
October 20, 2010
Last Verified
October 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Vasculitis
- Peripheral Vascular Diseases
- Phlebitis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics
- Protective Agents
- Membrane Transport Modulators
- Anticonvulsants
- Calcium-Regulating Hormones and Agents
- Reproductive Control Agents
- Calcium Channel Blockers
- Tocolytic Agents
- Cryoprotective Agents
- Magnesium Sulfate
- Glycerol
Other Study ID Numbers
- D/09/481
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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