Investigation of the Local Effect of Propolis Cream on The infection and the time of the occurrence of amiodarone-induced Phlebitis in Cardiac Patients Admitted to Ali-ebn Abitaleb Hospital in Rafsanjan City in 2018
Investigation of the Local Effect of Propolis Cream on the time of the occurrence and The infection of amiodarone-induced Phlebitis in Cardiac Patients
Design
Clinical trials with control group, with parallel groups, blind, randomized
Settings and conduct
This study is a double blind study. Participants and researchers are unaware of the allocation of study groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Venous access for at least 72 hours, The absence of skin and peripheral vascular diseases, Healthy upper limb, The absence of phlebitis in the anjection site, No use of steroids, heparin, injectable nitroglycerin, Age is more than 18 years old.
Exclusion criteria:Unwanted side effects, Any factor other than causes the patient to get out of the reach of 72 hours
Intervention groups
In intervention group, After fixing the angiocate 0.5 CC Propolis cream is used topically in the distal Angiocot.
In control group, After fixing the angiocate 0.5 CC Eucerin cream is used topically in the distal Angiocot.
Main outcome variables
Investigating the location of angiocat for the In terms of creation phlebitis and amiodarone infection
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20131228015965N14
Registration date:2019-05-11, 1398/02/21
Registration timing:retrospective
Last update:2019-05-11, 1398/02/21
Update count:0
Registration date
2019-05-11, 1398/02/21
Registrant information
Name
Majid Kazemi
Name of organization / entity
Rafsanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3425 7663
Email address
dr.kazemi.n@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-10, 1397/03/20
Expected recruitment end date
2018-10-12, 1397/07/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the Local Effect of Propolis Cream on The infection and the time of the occurrence of amiodarone-induced Phlebitis in Cardiac Patients Admitted to Ali-ebn Abitaleb Hospital in Rafsanjan City in 2018
Public title
Investigation of the Local Effect of Propolis Cream on The infection and the time of the occurrence
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Venous access for at least 72 hours,
The absence of skin and peripheral vascular diseases,
Healthy upper limb,
The absence of phlebitis in the anjection site,
No use of steroids, heparin, injectable nitroglycerin,
Age is more than 18 years old
Exclusion criteria:
Unwanted side effects
Any factor other than phlebitis that causes the patient to get out of the reach of 72 hours
Age
From 18 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
76
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is a double blind study. Participants and researchers are unaware of the allocation of study groups
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Rafsanjan University of Medical Sciences
Street address
Imam Ali Blvd, Rafsangan
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Approval date
2018-07-25, 1397/05/03
Ethics committee reference number
IR.RUMS.REC.1397.057
Health conditions studied
1
Description of health condition studied
Phlebitis
ICD-10 code
I80
ICD-10 code description
Phlebitis and thrombophlebitis
2
Description of health condition studied
infection
ICD-10 code
A49.8
ICD-10 code description
Other bacterial infections of unspecified site
Primary outcomes
1
Description
Phlebitis
Timepoint
Every 12 hours to 72 hours
Method of measurement
Checklist for phlebitis symptoms
2
Description
infection
Timepoint
After the end of the intervention
Method of measurement
CBC blood test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After fixing the angiocate 0.5 CC Propolis cream is used topically in the distal Angiocot
Category
Other
2
Description
Control group: After fixing the angiocate 0.5 CC Eucerin cream is used topically in the distal Angiocot
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali Ibn Abitaleb Hospital
Full name of responsible person
Ali Mosavi
Street address
Ali Ibn Abitaleb Hospital, Imam Ali Bolvard, Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0000
Email
Aliebn@rums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Ali Shamsizadeh
Street address
Imam Ali Bolvard, Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0038
Email
Alishamsy@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Hassan Pakdaman
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Imam Ali Bolvard, Rafsanjan
City
Rafsangan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0011
Email
hpm.pakdaman@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr. Majid Kazemi
Position
Assistant Professor, Faculty of Nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Rafsanjan University Of Medical Sciences, Imam Ali Blvd
City
Rafsanjan
Province
Kerman
Postal code
7717932777
Phone
+98 34 3425 5900
Email
dr.kazemi.n@rums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Hassan Pakdaman
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Imam Ali Bolvard, Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0011
Email
hpm.pakdaman@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD