NCT01226069

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
147

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 20, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 21, 2010

Completed
Last Updated

October 21, 2010

Status Verified

October 1, 2010

Enrollment Period

3 months

First QC Date

October 20, 2010

Last Update Submit

October 20, 2010

Conditions

Infection

Keywords

superficial phlebitiscannula-related vein inflammationGlycerine magnesium sulphateHirudoid creamNursing

Outcome Measures

Primary Outcomes (1)

  • Erythema size

    The incremental percentage change in erythema size

    5 days

Secondary Outcomes (1)

  • Time to resolve redness

    5 days

Study Arms (3)

Glycerine Magnesium Sulphate paste

ACTIVE COMPARATOR
Drug: Glycerine Magnesium sulphate paste

Hirudoid cream

ACTIVE COMPARATOR

Topical Mucopolysaccharide polysulphate

Drug: Mucopolysaccharide polysulphate

No application

EXPERIMENTAL

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

Interventions

Glycerine Magnesium sulphate pasteDRUG

Dosage to apply adheres to the manufacturer's recommendation. Sufficient amount should cover the erythema size. Dose frequency is 12 hourly.

Glycerine Magnesium Sulphate paste
Mucopolysaccharide polysulphateDRUG

Dosage to apply adheres to the manufacturer's recommendation. Sufficient amount should cover the erythema size. Dose frequency is 12 hourly.

Hirudoid cream
No applicationOTHER

No application

No application

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients admitted to the study institution between Dec 2009 and Feb 2010 and observed to develop redness associated with peripheral infusion cannula.

You may not qualify if:

  • Thrombosis, poor skin condition, and pus seen at the previous puncture.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tan Tock Seng Hospital

Singapore, Singapore, 308433, Singapore

Location

Related Publications (6)

  • 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: 19289920RESULT

  • 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: 8256008RESULT

  • 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: 14525568RESULT

  • 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: 12544367RESULT

  • 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.

    PMID: 10192751RESULT

  • 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.

    RESULT

MeSH Terms

Conditions

Infections

Study Officials

  • Isabel Ng, MSc Epidemiology

    Tan Tock Seng Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 20, 2010

First Posted

October 21, 2010

Study Start

November 1, 2009

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

October 21, 2010

Record last verified: 2010-10

Locations

SG(1)