Comparison of the effectiveness of Ichthammol glycerine,Heparinoid application and Magsulph glycerine application on the reduction of infusion related inflammation of the vein

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2013/12/004245
• Date of registration: 26-12-2013
• Prospective Registration: No
• Primary sponsor: Dr Sukhpal Kaur
• Public title: Comparison of the effectiveness of Ichthammol glycerine,Heparinoid application and Magsulph glycerine application on the reduction of infusion related inflammation of the vein
• Scientific title: Comparative efficacy, safety and pharmaco-economic evaluation of dressing with â??heparinoid preparationâ??, â??Magnesium Sulphate-glycerineâ?? and â??Ichthammol glycerineâ?? on phlebitis following peripheral intravenous cannulation: A double blinded randomized clinical trial,ACC, PGIMER, Chandigarh
• Date of first enrolment: 15-07-2013
• Target sample size: 120
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=7836
• Study type: Interventional
• Study design: Randomized, Parallel Group, Multiple Arm Trial; Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Participant and Outcome Assessor Blinded
• Phase: N/A

Countries of recruitment

India

Contacts

• Name: Bidisha Basu
• Affiliation: PGIMER

• Name: Dr Bikash Medhi
• Affiliation: PGIMER

Key inclusion & exclusion criteria

Inclusion criteria: All patients admitted in ACC,PGIMER,Chandigarh and develop

phlebitis as the result of intravenous therapy.

•Patients with visual infusion phlebitis score of two or more

•Patients with infusion related phlebitis and not received any form of intervention by the staff

•Patients who develop phlebitis only on the upper limbs.
Exclusion criteria: The patient/ legally acceptable representatives who are not willing to participate the study

- Patients who will be receiving chemotherapeutic agents

•Patients with central venous catheter on the same limb.

•Patients with dermatological disorders.

•Patients with any bleeding disorders,injury to the same limb,pre-existing lymphatic obstruction.

•Patients who are allergic to heparinoid or ichthammol glycerine or magsulph - glycerine

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Phlebitis following peripheral intravenous cannulation

Intervention(s)

Intervention1: Ichthammol glycerine: 3-5 ml of ichthammol glycerine will be taken for doing dressing on the affected site .Ichthammol glycerine local application will be done 2 times/day (12 hrsly)for 72 hours
Control Intervention1: Heparinoid Preparation: Heparinoid ointment should be applied in a thin layer to the skin of the affected part and its surrounding two times per day (12hrsly) for 72 hours.
Control Intervention2: Magsulph glycerine: Magsulph glycerine should be applied in a thin layer to the skin of the affected part and its surrounding two times per day (12hrly) for 72 hours.

Primary Outcome(s)

Study result helps in the provision of the most effective intervention for the management of post infusion intravenous cannulation phlebitisTimepoint: 6 weeks

Secondary Outcome(s)

Study result helps in the provision of the most pharmacoeconomic intervention for the management of post infusion intravenous cannulation phlebitisTimepoint: 6 weeks

Secondary ID(s)

Nil

Source(s) of Monetary Support

Nil

Secondary Sponsor(s)

Dr Bikash Medhi

Ethics review

Status: Approved
Approval date: 16/05/2013
Contact:

Institutional Ethics Committee (IEC), PGIMER, Chandigarh