A comparative study of the effect of nanoparticle silver dressing spray with chlorhexidine spray local infection of temporary central venous catheters in patients admitted to the special care units of selected Aja hospitals in Tehran A three-blind clinical trial
Comparison of the effect of silver nanoparticle dressing spray with chlorhexidine spray on the local infection of the temporary central vein catheter in patients admitted to the special care units of selected Aja hospitals in Tehran.
Design
In order to determine the sample size, using G Power version 3.0.10 software and Hendizadeh et al.'s study [33], taking into account the type 1 error of 0.05 and the test power of 80%, the number of samples for each group was calculated to be 21. With the possibility of dropping 10% of the samples, the number of 23 people was calculated for each group.
A blinded three-way study
Settings and conduct
23 people
Family hospitals, Imam Reza, Golestan and Baath
Participants/Inclusion and exclusion criteria
All patients with a central venous catheter hospitalized in the intensive care unit who meet the study entry criteria.
1) have a temporary subclavian or jugular central vein catheter.
2) GCS score greater than 12
3) Age over 18 years
4) hospitalization of the patient in the ward for at least three days
5) Lack of known immunodeficiency disease such as cancer, AIDS, organ transplant
6) Not using local antibiotics at the catheter insertion site
7) Absence of local infection at the first dressing change
8) Absence of sensitivity to the spray in the forearm test (redness and itching)
9) Catheters that have been placed less than 14 days
10) Informed consent and willingness to participate in the study
Intervention groups
All patients with a central venous catheter hospitalized in the intensive care unit who meet the study entry criteria.
Main outcome variables
Prevention of local infection
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221218056848N1
Registration date:2024-04-12, 1403/01/24
Registration timing:retrospective
Last update:2024-04-12, 1403/01/24
Update count:0
Registration date
2024-04-12, 1403/01/24
Registrant information
Name
mahdi nooriyan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5536 3273
Email address
mahdinooriyan1991@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-08, 1402/11/19
Expected recruitment end date
2024-03-09, 1402/12/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of the effect of nanoparticle silver dressing spray with chlorhexidine spray local infection of temporary central venous catheters in patients admitted to the special care units of selected Aja hospitals in Tehran A three-blind clinical trial
Public title
Comparison of the effect of silver nanoparticle dressing spray with chlorhexidine spray on local infection of temporary central venous catheter
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
1) having a temporary subclavian or jugular central vein catheter
2) GCS criteria greater than 12)
3) age over 18 years
4) hospitalization of the patient in the ward for at least three days
5) absence of a known immunodeficiency disease
6) No local antibiotic use at the catheter insertion site
7) No local infection at the first dressing change
8) No spray sensitivity in the forearm test (redness and itching)
9) Catheters that are less than 14 days after placement
10) Informed consent and willingness to participate in the study
Exclusion criteria:
1) Death or transfer to another hospital or ward
2) The impossibility of using the spray for any reason
3) removal of the catheter for any reason
4) Refusal to continue participating in the research
5) Taking local medicines in the area
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
23
Randomization (investigator's opinion)
Randomized
Randomization description
Allocation of samples to two groups of silver dressing spray and chlorhexidine spray will be done using the random allocation sequence generated by the Randomization site. These sequences will be A and B in numbered sealed envelopes. Also, arrangements will be made for the type of spray used, the most important of which is that the sprays will be placed in a package of the same shape and will be distinguished only by A or B. Silver spray and chlorhexidine are colorless and transparent and odorless.
Blinding (investigator's opinion)
Triple blinded
Blinding description
According to the purpose of the research and the initial sampling method, blinding will be done in two intervention and control groups, and all patients will not be aware of the type of spray used. Also, in order to prevent the effect of resonance, the researcher will be unaware of the use of sprays and the sprays will be delivered to the researcher with a single color coating. The statistical analyzer will not be aware of the type of spray A and B
Placebo
Not used
Assignment
Parallel
Other design features
no
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee Aja University of Medical Sciences
Street address
Etemadzadeh Street , Dr. Fatemi Street , Tehran
City
Tehran
Province
Tehran
Postal code
1613918151
Approval date
2024-03-04, 1402/12/14
Ethics committee reference number
IR.AJAUMS.REC.1402.233
Health conditions studied
1
Description of health condition studied
Central Venous Catheter Local Infection
ICD-10 code
L08.8
ICD-10 code description
Other specified local infections of the skin and subcutaneous tissue
Primary outcomes
1
Description
Central Catheter Local Infection
Timepoint
One Step a day for 7 days
Method of measurement
Observation Checklist of Local Infection
Secondary outcomes
empty
Intervention groups
1
Description
This research will be 3 groups. 2 intervention groups and a control group. The first intervention group: silver spray will be used for this group. Silver spray will be used in the central catheter site for seven days and once a day in the target group and the target site will be checked daily using the standard checklist in terms of the mentioned items and at the end the performance of the 3 solutions will be compared. .
Category
Prevention
2
Description
Intervention group: Chlorhexidine spray will be used for this group. Chlorhexidine spray will be used in the central catheter site for seven days and once a day in the target group, and the target site will be checked daily using the standard checklist in terms of the mentioned items, and at the end, the performance of the 3 solutions will be compared. .
Category
Prevention
3
Description
Control group: The routine action of the hospital (alcohol spray) will not be performed by the researcher for this group, and the routine action of the hospital will be checked and the changes of the catheter location will be checked according to the checklist and finally the performance of the 3 solutions will be compared.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
khanevadeh Hospital
Full name of responsible person
Mahdi Nooriyan
Street address
khanevadeh Hospital, Kaj Street, Serah Malik, Shariati Streetوو,Tehran
City
Tehran
Province
Tehran
Postal code
1843759447
Phone
+98 21 4382 4055
Email
haj_sh_13@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Reza Mosaed
Street address
Army University of Medical Sciences, Etemadzadeh Street, Fatemi Street, Tehran
City
Tehran
Province
Tehran
Postal code
1843759447
Phone
+98 21 8609 6354
Email
haj_sh_13@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Artesh 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
Artesh University of Medical Sciences
Full name of responsible person
Mahdi Nooriyan
Position
Non-Faculty
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
khanevadeh Hospital, Kaj Street, Serah Malek, Shariati Street,Tehran
City
Tehran
Province
Tehran
Postal code
1843759447
Phone
+98 21 4382 4055
Email
mahdinooriyan1991@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Yazdan Admadi
Position
Assistant Professor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Army School of Nursing, next to Family Hospital, Kaj Street, Serah Malek Street, Shariati Street, Tehran
City
Tehran
Province
Tehran
Postal code
1843759447
Phone
+98 21 4382 4055
Email
haj_sh_13@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Mahdi Nooriyan
Position
No- Facoulty
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Army School of Nursing, next to Family Hospital, Kaj Street, Serah Malek Street, Shariati Street,Tehran
City
Tehran
Province
Tehran
Postal code
1843759447
Phone
+98 21 7750 0201
Email
mahdinooriyan1991@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
The results of catheter site observations and the effect of intervention in reducing local infection
When the data will become available and for how long
Six months after the publication of the article
To whom data/document is available
All researchers and scientists in the fields of nursing and medicine
Under which criteria data/document could be used
Written request or email
From where data/document is obtainable
Email address haj_sh_13@yahoo.com
What processes are involved for a request to access data/document
As soon as the researcher receives the email and letter, it will be sent to them within a day or two