Comparison of the effect of aloe vera gel and chlorhexidine gluconate solution2 % on the prevention of phlebitis caused by peripheral vein catheters in patients admitted to the cardiac intensive care units
Determining and comparing the effect of aloe vera gel and 2% chlorhexidine gluconate solution on the prevention of phlebitis caused by peripheral vein catheters, in patients admitted to Amirul Mominin Hospital (AS) in Zabul city in 2023
Design
Participants are randomly assigned to three test groups using 2% chlorhexidine gluconate solution and aloe vera gel and the control group.
Settings and conduct
This research is a clinical trial study that will be conducted on patients hospitalized in the special care units of Amir al-Mominin Hospital. The participants will be randomly assigned to three test groups.
Participants/Inclusion and exclusion criteria
1. Voluntary participation in the study
2. Age 20 to 70 years
3. Having a healthy upper limb
4. Absence of phlebitis at the site before catheter placement
5. Not taking anticoagulants
6. No history of skin diseases, acute and chronic infection, severe anemia, glaucoma, hypotension (systolic pressure less than 100 mm Hg)
7. Lack of immune system defects
8. No chemotherapy
9. Lack of intravenous nutrition
Intervention groups
After washing the hands for 30 seconds with soap and water and wearing non-sterile gloves, disinfection in the first group is done first with 70% ethyl alcohol, and after drying and entering the venous catheter, then with angioket adhesive that is embedded in the part Its upper part is fixed with half a cc of 2% chlorhexidine gluconate solution, and in the second group, the catheter insertion site is first disinfected with 70% ethyl alcohol, and then after the angioket is inserted, the angioket adhesive pad is soaked with It is aloe vera gel.
Comparison of the effect of aloe vera gel and chlorhexidine gluconate solution2 % on the prevention of phlebitis caused by peripheral vein catheters in patients admitted to the cardiac intensive care units
Public title
Comparison of the effect of aloe vera gel and chlorhexidine gluconate solution2 % on the prevention of phlebitis caused by peripheral vein catheters in patients admitted to the cardiac intensive care units
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Voluntary participation in the study
Age 20 to 70 years
Having a healthy upper limb
Absence of phlebitis at the site before catheter placement
Not taking anticoagulants
No history of skin diseases, acute and chronic infection, severe anemia, glaucoma, hypotension (systolic pressure less than 100 mm Hg)
Lack of immune system defects
No chemotherapy
Lack of intravenous nutrition
Exclusion criteria:
Discharge from the hospital three days before the start of the intervention
Unwillingness to continue cooperation
Rupture or removal of the catheter before 72 hours
pregnancy
Sickness of the patient for any reason
Having diabetes
Simultaneous use of two or more antibiotics
Vasculitis and vascular involvement
Age
From 20 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
In this research, first, a list of patients who meet the research inclusion criteria will be prepared, and then the first person will be selected in the first intervention group, the second person will be in the third intervention group, and the third person will be selected in the random allocation method. A control will be placed and this work will continue until all research samples are placed in one of the two intervention or control groups.
Blinding (investigator's opinion)
Not 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 Zabul University of Medical Sciences
Street address
Shilat Square - Motahari Street - Motahari corner 2
City
زابل
Province
Sistan-va-Balouchestan
Postal code
9861664656
Approval date
2023-02-28, 1401/12/09
Ethics committee reference number
IR.ZBMU.REC.1401.152
Health conditions studied
1
Description of health condition studied
phlebitis
ICD-10 code
I80
ICD-10 code description
Phlebitis and thrombophlebitis
Primary outcomes
1
Description
phlebitis
Timepoint
Every 12 hours
Method of measurement
Phlebitis checklist
Secondary outcomes
1
Description
Phlebitis
Timepoint
Every 12 hours
Method of measurement
Phlebitis checklist
Intervention groups
1
Description
IntervenAfter washing your hands for 30 seconds with soap and water and wearing non-sterile gloves to protect yourself, preparing the intravenous fluid and serum set in a sterile way and choosing the appropriate vein, disinfection in the first group is done with 70% ethyl alcohol. And after the venous catheter is dried and inserted, then the upper part of the catheter insertion site is fixed with angioket adhesive, which has a pad embedded in its upper part, dipped in half a cc of 2% chlorhexidine gluconate solution.
Category
Prevention
2
Description
In the second group, the catheter insertion site is first disinfected with 70% ethyl alcohol, then the selected area, after drying and entering the venous catheter, is then smeared with half a cc of aloe vera gel with angioket adhesive, which has a pad embedded in its upper part. The upper part of the catheter entry point is fixed.
Category
Prevention
3
Description
In the control group, only the insertion site of the catheter is disinfected with 70% ethyl alcohol and the catheter is fixed using glue in a standard way. The date, time and name of the researcher are recorded. Every 12 hours to 72 hours, the site is checked and recorded for signs and degree of phlebitis. The serum set in 3 groups is changed every 24 hours and the duration of maintenance of the venous catheter is 72 hours.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir al-Mominin Ali (AS) Zabul Hospital
Full name of responsible person
Dr. Mohammad Ayman Abilinejad
Street address
3 km of Zabul-Zahedan road
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
5434211294
Phone
+98 54 3421 1300
Email
amirhospital@zbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zabol University of Medical Sciences
Full name of responsible person
Dr. Khadijah Rezaei Kikhaei
Street address
Zabol, Shahid Rajaei St
City
zabol
Province
Sistan-va-Balouchestan
Postal code
98616615881
Phone
+98 54 3223 0768
Email
Research@zbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zabol University of Medical Sciences
Proportion provided by this source
10
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
Zabol University of Medical Sciences
Full name of responsible person
Mahdieh Herati Nesab
Position
Special care master's student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shilat Square - Motahari Street
City
zabol
Province
Sistan-va-Balouchestan
Postal code
9861664656
Phone
+98 54 3223 6156
Email
mahdiyehharati742@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zabol University of Medical Sciences
Full name of responsible person
Mahin Naderi Far
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Sistan and Baluchestan province, Zabul city - 11 Ferdowsi St.
City
zabol
Province
Sistan-va-Balouchestan
Postal code
9861734184
Phone
+98 54 3222 3947
Email
mahin.naderifar@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zabol University of Medical Sciences
Full name of responsible person
Mahdia Herati Nesab
Position
Nursing Graduate Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shilat Square - Motahari Street - Motahari corner 2
City
zabol
Province
Sistan-va-Balouchestan
Postal code
9861664656
Phone
+98 54 3223 6156
Email
mahdiyehharati742@gmail.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