| 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 preparationâ€, “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
|
|
|
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
|
|
|
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 preparationâ€, “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 preparationâ€, “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. |