Effectiveness of Topical Glycerine Sulphate Paste, Hirudoid Cream and Nil Application on Superficial Phlebitis

This study has been completed.
Sponsor:
Information provided by:
Tan Tock Seng Hospital
ClinicalTrials.gov Identifier:
NCT01226069
First received: October 20, 2010
Last updated: NA
Last verified: October 2010
History: No changes posted
  Purpose

The aim of the interventional study is to compare the different treatment modalities in reducing erythema size and rate of resolving phlebitis.


Condition Intervention
Infection
Drug: Glycerine Magnesium sulphate paste
Drug: Mucopolysaccharide polysulphate
Other: No application

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: To Investigate the Effectiveness of Topical Glycerine Sulphate, Hirudoid Cream and Nil Application in Treating Peripheral Cannula Related Phlebitis

Resource links provided by NLM:


Further study details as provided by Tan Tock Seng Hospital:

Primary Outcome Measures:
  • Erythema size [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]
    The incremental percentage change in erythema size


Secondary Outcome Measures:
  • Time to resolve redness [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]
    The rate of phlebitis resolution


Enrollment: 147
Study Start Date: November 2009
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Glycerine Magnesium Sulphate paste Drug: 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
Drug: 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.
Other: No application
No application

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01226069

Locations
Singapore
Tan Tock Seng Hospital
Singapore, Singapore, 308433
Sponsors and Collaborators
Tan Tock Seng Hospital
Investigators
Principal Investigator: Isabel Ng, MSc Epidemiology Tan Tock Seng Hospital
  More Information

Publications:
Responsible Party: Isabel Ng Hui Leng, Tan Tock Seng Hospital
ClinicalTrials.gov Identifier: NCT01226069     History of Changes
Other Study ID Numbers: D/09/481
Study First Received: October 20, 2010
Last Updated: October 20, 2010
Health Authority: Singapore: Domain Specific Review Boards
Singapore: Health Sciences Authority

Keywords provided by Tan Tock Seng Hospital:
superficial phlebitis
cannula-related vein inflammation
Glycerine magnesium sulphate
Hirudoid cream
Nursing

Additional relevant MeSH terms:
Phlebitis
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases
Vasculitis
Glycerol
Magnesium Sulfate
Cryoprotective Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anesthetics
Central Nervous System Depressants
Anti-Arrhythmia Agents
Cardiovascular Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Tocolytic Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on August 28, 2014