The effect of Mentha piperita gel dressing for the prevention of phlebitis and local colonization in patients undergoing hemodialysis with temporary central venous catheter
To assess The effect of Mentha piperita gel dressing for the prevention of phlebitis and local colonization in patients undergoing hemodialysis with temporary central venous catheter
Design
Double-blind randomized controlled trial, non-Inferiority, with a parallel group design, on 60 patients, randomized using random sequences generated by the randomization site and numbered in sealed envelopes.
Settings and conduct
This study is a randomized clinical trial on 60 patients undergoing hemodialysis with a temporary central venous catheter in the nephrology ward of Imam Reza Hospital. Patients are randomly divided into two groups of chlorhexidine-impregnated dressing and Mentha piperita and are homogeneous in terms of diabetes in the two groups. These gels are in two similar tube A and B with the same color, smell and appearance. After 24 hours of catheter placement, the control group dressing was impregnated with chlorhexidine gel and the intervention group was impregnated with Mentha piperita gel. These dressings were impregnated with gel twice daily for maximum 14 days and the catheter site was examined daily with Iranian Nurses Association's Inflammatory Criteria. If there was signs of vascular inflammation with score 2 or more, the culture sample will be taken with a sterile swab from the skin around the catheter and sent to the laboratory to be examined for colonization.
Participants/Inclusion and exclusion criteria
Patients undergoing hemodialysis with temporary central venous catheter
Intervention groups
In the intervention group, the central venous catheter dressing was impregnated with Mentha piperita gel 10% and in the control group impregnated with 2% chlorhexidine gel and used twice daily for a maximum of 14 days.
Main outcome variables
Phlebitis and local colonization at catheter insertion site
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220317054324N1
Registration date:2022-04-30, 1401/02/10
Registration timing:prospective
Last update:2022-04-30, 1401/02/10
Update count:0
Registration date
2022-04-30, 1401/02/10
Registrant information
Name
Mohadeseh Gholami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 933 213 4143
Email address
gholamijm992@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-22, 1401/03/01
Expected recruitment end date
2022-08-23, 1401/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Mentha piperita gel dressing for the prevention of phlebitis and local colonization in patients undergoing hemodialysis with temporary central venous catheter
Public title
The effect of Mentha piperita dressing for the prevention of phlebitis and local colonization
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
The Patient is undergoing hemodialysis due to acute or chronic renal failure
The patient has a temporary central venous catheter that is inserted into subclavian or jugular vein
Age between 18-60 years
The Patient may be hospitalized in the ward for at least 3 days
Lack of a known immune deficiency disease such as cancer, AIDS
Do not take topical antibiotics and anti-inflammatory at catheter insertion site in a recent week
No occurrence of phlebitis at the first change of dressing
Lack of sensitivity to the gel in the forearm test
Exclusion criteria:
Systemic and local infection at the catheter insertion site
Do not use or can not use the gel for any reason
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In this randomized, controlled, double-blind parallel group trial, 60 patients are randomly divided into intervention and control groups. For simple random allocation, two sequences produced by the randomization site are used, one of which is for random allocation of patients with diabetes and the other is related to the allocation of other patients. in this way, After the available sampling, if the patient has diabetes, the allocation of these patients will be done by a random sequence of patients with diabetes to homogenize the distribution of these patients between the two groups. These two sequences will be placed separately in two different boxes. Each sequences inside the box will be numbered A and B in the sealed envelopes. Mentha piperita (peppermint) and chlorhexidine gels prepare in two similar tubes with the same color and smell and distinguishe from each other only with A and B. Only a pharmacist is aware of type of gels. patients and relatives are not aware of the type of gel, as well as outcome assessor.
Blinding (investigator's opinion)
Double blinded
Blinding description
The naming of tubes to A and B will be carried out by the pharmacologist assistant in the laboratory of the Faculty of Iranian and complementary medicine of Mashhad University of Medical Sciences and only the pharmacologist is aware of the type of gel. Mentha piperita and chlorhexidine gels prepare in two similar tubes with the same color and smell and distinguishe from each other only with A and B.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics committee of School of Nursing & Midwifery Mashhad University of Medical Sciences
Street address
Faculty of Nursing & Midwifery, Ebne Sina Street, doctora Cross, Daneshgah Ave, Mashhad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2022-03-15, 1400/12/24
Ethics committee reference number
IR.MUMS.NURSE.REC.1401.003
Health conditions studied
1
Description of health condition studied
Renal failure
ICD-10 code
(N17-N19)
ICD-10 code description
renal failure
Primary outcomes
1
Description
phlebitis
Timepoint
Before the start of the intervention, daily up to maximum 14 days after the intervention
Once If there was signs of vascular inflammation (phlebitis) with score 2 or more
Method of measurement
Blood agar culture and sending samples to Microbiology Laboratory
Intervention groups
1
Description
Intervention group: Mentha piperita extract gel will be used in the intervention group.The researcher will prepare this gel based on carbapol in the laboratory of the Faculty of Iranian and Complementary Medicine of Mashhad University of Medical Sciences under the supervision of a pharmacologist. Mentha piperita is purchased from centers approved by the Faculty of Iranian and Complementary Medicine. Mentha piperita is soaked in a ratio of one to three in hydroalcoholic solvent (30% water and 70% alcohol). After 48 hours, the liquid extract is filtered and the solvent is removed to finally obtain a solid plant extract. Standardization of mint extract is done and then this extract will be prepared in 10% gel base and packed in a tube. For 24 hours after catheter placement, the researcher will change the catheter dressing daily in the morning and then disinfect it with betadine and wash the betadine with normal saline from the wound and apply the gel within a radius of 2.5. After 12 hours, the dressing is opened and the area is impregnated with gel and the same dressing is placed on the site. The researcher, in coordination with the staff, will ensure the use of the gel by face-to-face control or telephone reminders.These dressings are impregnated with gel twice a day for a maximum of 14 days and the catheter site is examined daily with Iranian Nurses Association's Inflammatory Criterial.
Category
Prevention
2
Description
Control group: In this group, 2% chlorhexidine gel is prepared and used. The use of the gel and the evaluation of the catheter entry site for phlebitis and local colonization will be performed in the same way as the intervention group.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Educational, Research and Therapeutic Hospital
Full name of responsible person
Seyed Reza Mazlom
Street address
Emam Reza Hospital, Emam Reza Sq, Ebne Sina St, Mashhad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
Mazlomr@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Talat Khadivzadeh
Street address
Faculty of Nursing & Midwifery, Ebne Sina Street, doctora Cross, Daneshgah Ave, Mashhad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
nms.pr@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
mohadeseh gholami jami ghaleh shiri
Position
MSC student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Floor 1, No 117, After of 1th crrosroads, Tabatabayee 22, Tabatabayee street, Askariyeh sq, Tollab District, Mashhad town, Khorasan Razavi, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9157697635
Phone
+98 51 3251 6989
Email
gholamijm992@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Seyed Reza Mazlom
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing & Midwifery, Ebne Sina Street, doctora Cross, Daneshgah Ave, Mashhad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
00985138598019-207
Email
Mazlomr@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
mohadeseh gholami jami ghaleh shiri
Position
MSC student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Floor 1, No 117, After of 1th crrosroads, Tabatabayee 22, Tabatabayee street, Askariyeh sq, Tollab District, Mashhad town, Khorasan Razavi, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9157697635
Phone
+98 51 3251 6989
Email
gholamijm992@mums.ac.ir
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
Yes - There is a plan to make this available
Title and more details about the data/document
After determining the results, the information will be provided to the Vice Chancellor of Mashhad University of Medical Sciences for implementation in affiliated hospitals and also transferred to the Ministry of Health. Also, some data will be published in scientific journals as the main results of the research within 6 months.
When the data will become available and for how long
6 months after the results are published
To whom data/document is available
Researches who are researching in this field (complementary and Alternative Medicine)
Under which criteria data/document could be used
Analysis of main variables
From where data/document is obtainable
Researcher email
What processes are involved for a request to access data/document
The data will be provided to the applicants after 1 month.