Effect of Washing With Clove Extract on Inflammation and Infection Place Logging Shaldon Needle
Primary Purpose
Renal Failure
Status
Unknown status
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
clove extract
Betadine
Sponsored by
About this trial
This is an interventional prevention trial for Renal Failure focused on measuring inflammation, infection
Eligibility Criteria
Inclusion Criteria:
- age between 18-80
Exclusion Criteria:
- lack of cooperation patient to participate in the post test
Sites / Locations
- Mashhad Faculty of Nursing and MidwiferyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
inflammation
infection
Arm Description
The effect of washing with betadine and clove extract on incidence of inflammation place logging shaldon catheter in the hemodialysis patients
The effect of washing with betadine and clove extract on incidence of infection place logging shaldon catheter in the hemodialysis patients
Outcomes
Primary Outcome Measures
inflammation severity questionnaire
effects of washing with clove extract on inflammation place logging shaldon needles in the hemodialysis patients that will be measured with inflammation severity questionnaire.
Secondary Outcome Measures
Full Information
NCT ID
NCT02865980
First Posted
August 8, 2016
Last Updated
August 10, 2016
Sponsor
Mashhad University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT02865980
Brief Title
Effect of Washing With Clove Extract on Inflammation and Infection Place Logging Shaldon Needle
Official Title
Effect of Washing With Clove Extract on Inflammation and Infection Place Logging Shaldon Needle
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
August 2016 (undefined)
Primary Completion Date
October 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mashhad University of Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This randomized clinical trial will conducted involving 60 patients under hemodialysis and hospitalized to Imam Reza and Montasareyeh hospitals of Mashhad in 2016. Patients were assigned to experimental and control groups of 30 people, randomly (double block). In the both intervention and control group, first will be washed the Catheter with Betadine, but in intervention group, after 2 minutes will be used of the clove extract with 2 ml of scrub for 15 seconds. The incidence and severity of inflammation as well as infection of vascular access will be assessed in patients on hemodialysis for each patient before starting the process over a period of 2 weeks is equivalent to 6 sessions of hemodialysis.
Detailed Description
This study is a randomized clinical trial that will conducted on 60 patients under hemodialysis and hospitalized to Imam Reza and Montasareyeh hospitals of Mashhad in 2016. Patients were assigned to experimental and control groups of 30 people, randomly (double block).
In the both intervention and control group, first will be washed the shaldon catheter with Betadine, but in intervention group, after 2 minutes will be used of the clove extract with 2 ml of scrub for 15 seconds. The incidence and severity of inflammation as well as infection of vascular access will be assessed in patients on hemodialysis for each patient before starting the process over a period of 2 weeks is equivalent to 6 sessions of hemodialysis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Failure
Keywords
inflammation, infection
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
inflammation
Arm Type
Experimental
Arm Description
The effect of washing with betadine and clove extract on incidence of inflammation place logging shaldon catheter in the hemodialysis patients
Arm Title
infection
Arm Type
Experimental
Arm Description
The effect of washing with betadine and clove extract on incidence of infection place logging shaldon catheter in the hemodialysis patients
Intervention Type
Other
Intervention Name(s)
clove extract
Intervention Description
in intervention group, first will be washed the Catheter with Betadine after 2 minutes will be used of the clove extract with 2 ml of scrub for 15 seconds. The incidence of inflammation of vascular access will be assessed in patients on hemodialysis for each patient before starting the process over a period of 2 weeks is equivalent to 6 sessions of hemodialysis.
Intervention Type
Other
Intervention Name(s)
Betadine
Intervention Description
in control group, will be washed the Catheter with Betadine
Primary Outcome Measure Information:
Title
inflammation severity questionnaire
Description
effects of washing with clove extract on inflammation place logging shaldon needles in the hemodialysis patients that will be measured with inflammation severity questionnaire.
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
age between 18-80
Exclusion Criteria:
lack of cooperation patient to participate in the post test
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ali Bazzi, MSc
Phone
989113723582
Email
bazzia911@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ali Bazzi, MS
Phone
989113723582
Email
bazzia911@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali Bazzi, MSc
Organizational Affiliation
Mashhad Faculty Nursing and Midwifery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mashhad Faculty of Nursing and Midwifery
City
Mashhad
State/Province
Khorasan Razavi
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ali Bazzi, MSc
Phone
989113723582
Email
bazzim911@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
22430697
Citation
Chaudhari LK, Jawale BA, Sharma S, Sharma H, Kumar CD, Kulkarni PA. Antimicrobial activity of commercially available essential oils against Streptococcus mutans. J Contemp Dent Pract. 2012 Jan 1;13(1):71-4. doi: 10.5005/jp-journals-10024-1098.
Results Reference
result
Links:
URL
http://ncbi.nlm.nih.gov/pubmed/22430697
Description
abstract article
Learn more about this trial
Effect of Washing With Clove Extract on Inflammation and Infection Place Logging Shaldon Needle
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