Comparison of the effects of Chlorhexidine solution, Alcohol and Alcohol-Chlorhexidine on complications of Peripheral venous catheter (phlebitis and local infections)
The purpose of this study was to compare the effect of using disinfectant solutions before injection (alcohol, chlorhexidine and alcohol+chlorhexidine) on the complications of intravenous catheterization in patients. This study was conducted on 147 patients who were eligible to enter the study by having inclusion criteria such as 18-60 years old age, healthy upper limb, lack of other underlying conditions like cancer, etc. Patients were randomly divided into three groups of 49 people. Before the intervention, they were provided with some explanations for the study and the written consent was obtained from them. The catheter injection site was checked for phlebitis every 12 hours. Nursing Association’s phlebitis scale was used to evaluate phlebitis, which a score more than 2 was considered as phlebitis according to the scale. At the time of the catheter exit, for any reason, the tip of the catheter in a sterilized way with no contact to the skin surface was separated with a sterile scissor and sent to the laboratory for a microbiological examination. Angiocatheter tip culture was prepared in a semi-quantitative manner in an agar medium. The number of colonies emerging in the culture medium was counted after 48 hours. If their number is more than 15, the catheter is considered infectious. In this study, the patient and phlebitis and laboratory assessor were unaware and blind to the disinfectant substance before cannulation.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017050532293N2
Registration date:2017-10-29, 1396/08/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-10-29, 1396/08/07
Registrant information
Name
Hamed Sarani
Name of organization / entity
Zahedan University Medical Siences
Country
Iran (Islamic Republic of)
Phone
+98 54 3344 2481
Email address
sarani@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Zahedan University of Medical Sciences .Dr Noormohammad Bakhshani
Expected recruitment start date
2017-06-22, 1396/04/01
Expected recruitment end date
2018-03-22, 1397/01/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of Chlorhexidine solution, Alcohol and Alcohol-Chlorhexidine on complications of Peripheral venous catheter (phlebitis and local infections)
Public title
Effects of Chlorhexidine solution, Alcohol and Alcohol-Chlorhexidine on complications of Peripheral venous catheter
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Age over 18 years; At least for 72 hours need to have an intravenous catheter; Does not have underlying diseases, such as leukemia, immune deficiency, diabetes and dermatitis; Do not sensitive to adhesive or injection; No blood transfusion; Not been in hemodialysis; Have a healthy upper limbs and healthy upper extremity skin with natural color; have Systolic pressure above 90 mm Hg.
Exclusion criteria: Accidents that lead to early replacement of the catheter; injecting a drug solution that is effective on duration of catheter replacement as hypertonic solutions (manitol, dextrose 50%, dextrose20%, dextrose saline, etc.)
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
147
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Zahedan University of Medical Sciences
Street address
Zahedan University of Medical Sciences, Dr Hesabi Sq, University Street, Zahedan, Iran
City
Zahedan
Postal code
9816653948
Approval date
2017-05-28, 1396/03/07
Ethics committee reference number
IR.ZAUMS.REC.1396. 37
Health conditions studied
1
Description of health condition studied
Local infection
ICD-10 code
L08
ICD-10 code description
Other local infections of skin and subcutaneous tissue
2
Description of health condition studied
Phlebitis and thrombophlebitis
ICD-10 code
I80.9
ICD-10 code description
Phlebitis and thrombophlebitis of unspecified site
Primary outcomes
1
Description
Phlebitis
Timepoint
12 Hour after venous catheterization;24Hour after venous catheterization;36Hour after venous catheterization;48;60Hour after venous catheterization
Method of measurement
Phlebitis Grading Scale
Secondary outcomes
1
Description
Local catheter site infection
Timepoint
After removing the IV catheter
Method of measurement
Based on the test results and the number of colonies grown culture from the catheter tip
Intervention groups
1
Description
The catheter injection site was initially disinfected by application of alcohol with the brand of “Manicol” which is a product of “Sina Fariman Chemical Industry” and then the cannulation was conducted. As well as, the site of the catheter was fixed with sterile dressing gauze and anti-allergic band aid.
Category
Prevention
2
Description
The catheter injection site was initially disinfected by application of Chlorhexidine with the brand of “Epimax U” which is a product of “Emad Pharmaceutical company” and then the cannulation was conducted. As well as, the site of the catheter was fixed with sterile dressing gauze and anti-allergic band aid.
Category
Prevention
3
Description
The catheter injection site was initially disinfected by application of alcohol-Chlorhexidine with the brand of “Epimax” which is a product of “Emad Pharmaceutical company” and then the cannulation was conducted. As well as, the site of the catheter was fixed with sterile dressing gauze and anti-allergic band aid.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Khatam al anbia hospital
Full name of responsible person
Hamed sarani
Street address
City
Zahedan
2
Recruitment center
Name of recruitment center
Ali ebn abitaleb hospital
Full name of responsible person
Hamed sarani
Street address
City
Zahedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Zahedan University of Medical Sciences
Full name of responsible person
Dr. Noormohammad Bakhshani
Street address
Zahedan University of Medical Sciences, Dr Hesabi Sq
City
Zahedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Zahedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Hamed Sarani
Position
Master
Other areas of specialty/work
Street address
Mashahir Sq. Nursing and Midwifery Department
City
Zahedan
Postal code
9816653948
Phone
+98 54 3344 2481
Fax
Email
sarani@zaums.ac.irhamedsarani@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Hamed Sarani
Position
Master
Other areas of specialty/work
Street address
Mashahir Sq. Nursing and Midwifery Department
City
Zahedan
Postal code
Phone
+98 54 3344 2481
Fax
Email
sarani@zaums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Enayatollah Safarzai
Position
Master student of Medical- Surgical Nursing,
Other areas of specialty/work
Street address
Nursing and Midwifery Department, mashahir Sq
City
Zahedan
Postal code
Phone
00
Fax
Email
e.safarzai@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)