Comparison of the effect of sesame oil and Chlorhexidine Gluconate solution 2% on the prevention of phlebitis related to peripheral venous catheter in patients admitted to the CCU wards
This study will be conducted to determine the effect of external use of Sesame oil (SO) and Chlorhexidine Gluconate solution 2% in prevention of phlebitis related to peripheral venous catheter in patients admitted to the CCU wards of AJA hospitals Tehran. Materials & Methods: 60 patients who admitted in CCU, were enrolled in a clinical trial and they randomly divided in three equal, control & intervention 1 and 2, groups. in 1 intervention group(SO), as 5 drops of sesame oil, will be rubbed 5 cm around the area of intravenous catheter with a Clean Applicator and a new IV dressing will be fixed . for the other intervention group, Chlorhexidine Gluconate solution 2% will be sprayed at the same radius. from the first day, intervention will be done three times (every 24 hours during 72 hours). In the control group, every 24 hours, only the severity of phlebitis will be graded.
Data tools included a bipartite questionnaire (demographic Q & clinical Q) and standard Visual infusion phlebitis Scale (VIP) for measurement of phlebitis (scored 0 to 5).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016053023446N7
Registration date:2016-07-30, 1395/05/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-07-30, 1395/05/09
Registrant information
Name
Fatemeh Teymouri
Name of organization / entity
AJA University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5588 0283
Email address
z.farsi@ajaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Aja University of Medical Science
Expected recruitment start date
2016-06-09, 1395/03/20
Expected recruitment end date
2016-09-10, 1395/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of sesame oil and Chlorhexidine Gluconate solution 2% on the prevention of phlebitis related to peripheral venous catheter in patients admitted to the CCU wards
Public title
Comparison of the effect of sesame oil and Chlorhexidine Gluconate solution 2% on the prevention of phlebitis .
Purpose
Prevention
Inclusion/Exclusion criteria
1. being 35-75 years of old
2.consciousness
3.Having informed consent
4.The first day of hospitalization, less than 24 hours have passed since the catheter
5. no phlebitis at first
6.catheterization into arm vein
7.alcohol 70% as a disinfectant before use catheter for disinfectant
8.The patient has no previous phlebitis at the IV insertion site
9.the patient will require at least 72 hours to catheter venous
having venous catheter
10. Lack of skin and vascular disease
11. the patient is not allergic to Sesame and its products
12.no fever, At baseline
13.Patients with not impaired immune systems
14.Lack of leukemia and history of Chemotherapy
15.No need for hemodialysis
16. lack of venous /arterial central line
17. Application No. 2o catheter
18.Lack of amiodarone therapy, vancomycin, phenytoin, diazepam, acyclovir, hypertonic products, calcium gluconate intravenous, cephalosporin
Exclusion criteria:1.Refusing to continue the study 2.discharge before 72 hours 3.Injection drug or hypertonic solutions, Antibiotics and other drugs listed at Inclusion criteria ,Through via this catheter
4.Lost the catheter
Age
From 35 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Aja university of Medical Science
Street address
fatemi S, Etemad zade S, Aja university of Medical Science
City
Tehran
Postal code
Approval date
2016-05-09, 1395/02/20
Ethics committee reference number
IR.AJAUMS.REC.1395.05
Health conditions studied
1
Description of health condition studied
phlebitis
ICD-10 code
I80.9
ICD-10 code description
Phlebitis and thrombophlebitis of unspecified site
Primary outcomes
1
Description
phlebitis
Timepoint
daily
Method of measurement
Visual Infusion Phlebitis Scale
Secondary outcomes
1
Description
pain, redness, swelling
Timepoint
daily
Method of measurement
observation, interview
Intervention groups
1
Description
at first day, in 1 intervention group(SO), as 5 drops of sesame oil, will be rubbed 5 cm around the area of intravenous catheter with a Clean Applicator by reasercher and a new IV dressing will be fixed. This continues for 24 and 48 hours later by a research assistant.
Category
Prevention
2
Description
In the control group, every 24 hours ( for 72 hours) only the severity of phlebitis will be graded and a new IV dressing will be fixed.
Category
Prevention
3
Description
for the other intervention group, Chlorhexidine Gluconate solution 2% will be sprayed at 5 cm around the catether and after drying, a new IV dressing will be fixed. This continues for 24 and 48 hours later by a research assistant.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
besat hospital , ccu
Full name of responsible person
Street address
afsariye S
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Aga University of Medical Science
Full name of responsible person
Farsi Zahra
Street address
Shariati S, Kaj S, Aja Nursing Factuly
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Aga University of Medical Science
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
Aja university of Medical Science
Full name of responsible person
Farsi Zahra
Position
PhD/Assistant Professor
Other areas of specialty/work
Street address
Shariati S, Kaj S, Aja nursing factuiy
City
Tehran
Postal code
Phone
+98 21 7750 0929
Fax
Email
z.farsi@ajaums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Aja University of Medical Science
Full name of responsible person
poormohammadi maryam
Position
Master of science nursing student
Other areas of specialty/work
Street address
Shariati S, Kaj S, Aja nursing factuly
City
Tehran
Postal code
Phone
+98 21 7750 0929
Fax
Email
Maryam.poormohamadi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Aja university of Medical Science
Full name of responsible person
poormohammadi maryam
Position
Master of science nursing student
Other areas of specialty/work
Street address
City
Postal code
Phone
+98 21 7750 0929
Fax
Email
Maryam.poormohamadi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)