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CTRI Number  CTRI/2013/12/004245 [Registered on: 26/12/2013] Trial Registered Retrospectively
Last Modified On: 09/11/2013
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   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 of Study   Comparative efficacy, safety and pharmaco-economic evaluation of dressing with “heparinoid preparation”, “Magnesium Sulphate-glycerine” and “Ichthammol glycerine” on phlebitis following peripheral intravenous cannulation: A double blinded randomized clinical trial,ACC, PGIMER, Chandigarh  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Bidisha Basu 
Designation  MSc.Nursing student 
Affiliation  National Institute of Nursing Education 
Address  Final Year M.Sc. Nursing student National Institute of Nursing Education
PGIMER
Chandigarh
CHANDIGARH
160012
India 
Phone  9872613698  
Fax    
Email  basubidisha@ymail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Bikash Medhi 
Designation  Additional Proffessor 
Affiliation  PGIMER 
Address  Research Block- 4th floor Room No: 4043

Chandigarh
CHANDIGARH
160012
India 
Phone  91-172-2755250  
Fax    
Email  drbikashus@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Bidisha Basu 
Designation  M.Sc. Nursing Student 
Affiliation  PGIMER 
Address  Final Year M.Sc. Nursing student National Institute of Nursing Education

Chandigarh
CHANDIGARH
160012
India 
Phone  9872613698  
Fax    
Email  basubidisha@ymail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Dr Sukhpal Kaur 
Address  Lecturer, National Institute of Nursing Education, PGIMER,Chandigarh 
Type of Sponsor  Other [Research Guide] 
 
Details of Secondary Sponsor  
Name  Address 
Dr Bikash Medhi  Additional Professor, Department of Pharmacology, Research Block B, Room No 4043 ,PGIMER, Chandigarh India 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Bikash Medhi  Cardiology wards and CTVS wards,Advanced Cardiac Centre, PGIMER, Chandigarh  Advanced Cardiac Centre, Postgraduate Institute of Medical Education and Research, Chandigarh
Chandigarh
CHANDIGARH 
0172-2755250

drbikashus@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (IEC), PGIMER, Chandigarh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Phlebitis following peripheral intravenous cannulation,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  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.  
Intervention  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  
Comparator Agent  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.  
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  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. 
 
ExclusionCriteria 
Details  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 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Study result helps in the provision of the most effective intervention for the management of post infusion intravenous cannulation phlebitis  6 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Study result helps in the provision of the most pharmacoeconomic intervention for the management of post infusion intravenous cannulation phlebitis  6 weeks 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/07/2013 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="1"
Days="15" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Will be published in journal after the conduction of the Study 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  
This study aims at Comparative efficacy, safety and pharmaco-economic evaluation of dressing with “heparinoid preparation”, “Magnesium Sulphate-glycerine” and “Ichthammol glycerine” on phlebitis following peripheral intravenous cannulation. The medical science and technology has been progressing and is accompanied by the use of new diagnostic and therapeutic devices. Peripheral intravenous catheter is one of the most commonly used device for the infusion of medications fluids and blood products.Phlebitis is the most common complications associated with intravenous therapy. In PGIMER, Chandigarh the treatment measures for phlebitis include heparinoid application or Magsulph- glycerine application, but not on any fixed manner. All the measures have been found to be effective for the treatment of phlebitis. But there is not much evidence to identify the most effective measure for reducing the signs and symptoms of phlebitis. In PGIMER,Chandigarh no studies have been done to compare the effectiveness of the most commonly used treatment options ie.Magsulf- glycerine and heparinoid application on phlebitis. Therefore a study needs to be conducted to determine the prevalence of phlebitis and to identify the effective treatment measure for the management of phlebitis.
The data was collected from the wards of advanced cardiac centre for the time period of 6 weeks from 15/07/2013 to 31/08/2013. Randomised Trial design was used to measure and compare the effectiveness of heparinoid application and ichthammol glycerine and magsulf-glycerine application on the reduction of the phlebitis. The wards of ACC, PGIMER, Chandigarh were assigned to each interventional group(either heparinoid application or ichthammol glycerine or magsulf-glycerine application ) by computer generated Block randomisation method.
Every day the patients with intravenous cannula who fullfill the inclusion criteria were assessed for phlebitis by using visual infusion phlebitis scale.The investigator explained the purpose of the study and obtained written informed consent from the participants.The observerational and participational blinding had done. The observer used to give marks by using the visual infusion phlebitis scale and numeric pain intensity scale .The patients were tested for allergic skin reaction before the administration of the intervention. All the interventions were given two times per day (12 hrsly) for 72 hrs or till the reduction of phlebitis score to 0.Time taken for the application of each intervention also was noted. First observation was done after 24 hours of the application of the intervention, second observation at 48 hours, third observation at 72 hours to Compare the efficacy, safety and pharmaco-economic evaluation of dressing with “heparinoid preparation”, “Magnesium Sulphate-glycerine” and “Ichthammol glycerine” on phlebitis following peripheral intravenous cannulation. None of the participants develop allergic skin reaction .For all the subjects who participated in the study ,phlebitis resolved with in 48-72 hours.
Currently analysis is under process.
 
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