Effectiveness of Topical Glycerine Sulphate Paste, Hirudoid Cream and Nil Application on Superficial Phlebitis - Full Text View

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:

Drug Information available for: Glycerin Magnesium Magnesium sulfate Sulfate ion

U.S. FDA Resources

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

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:

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. Review.

Almenar L, Hernández 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.

Cökmez A, Gür S, Genç 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.

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.

Vilardell M, Sabat D, Arnaiz JA, Bleda MJ, Castel JM, Laporte JR, Vallvé 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.

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 May 23, 2013