NCT02865980

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

August 8, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 15, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

August 15, 2016

Status Verified

August 1, 2016

Enrollment Period

2 months

First QC Date

August 8, 2016

Last Update Submit

August 10, 2016

Conditions

Renal Failure

Keywords

inflammation, infection

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 weeks

Study Arms (2)

inflammation

EXPERIMENTAL

The effect of washing with betadine and clove extract on incidence of inflammation place logging shaldon catheter in the hemodialysis patients

Other: clove extractOther: Betadine

infection

EXPERIMENTAL

The effect of washing with betadine and clove extract on incidence of infection place logging shaldon catheter in the hemodialysis patients

Other: clove extractOther: Betadine

Interventions

clove extractOTHER

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.

infectioninflammation
BetadineOTHER

in control group, will be washed the Catheter with Betadine

infectioninflammation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age between 18-80

You may not qualify if:

  • lack of cooperation patient to participate in the post test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mashhad Faculty of Nursing and Midwifery

Mashhad, Khorasan Razavi, Iran

RECRUITING

Related Publications (1)

  • 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.

    PMID: 22430697RESULT

Related Links

MeSH Terms

Conditions

Renal InsufficiencyInflammationInfections

Interventions

Phosphatidylinositol 3-KinasesPovidone-Iodine

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phosphotransferases (Alcohol Group Acceptor)PhosphotransferasesTransferasesEnzymesEnzymes and CoenzymesIntracellular Signaling Peptides and ProteinsProteinsAmino Acids, Peptides, and ProteinsIodophorsIodine CompoundsInorganic ChemicalsPolyvinylsVinyl CompoundsAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsPovidonePyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPlasticsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Ali Bazzi, MSc

    Mashhad Faculty Nursing and Midwifery

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ali Bazzi, MSc

CONTACT

989113723582bazzia911@gmail.com

Ali Bazzi, MS

CONTACT

989113723582bazzia911@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mashhad Faculty of Nursing and Midwifery

Study Record Dates

First Submitted

August 8, 2016

First Posted

August 15, 2016

Study Start

August 1, 2016

Primary Completion

October 1, 2016

Study Completion

December 1, 2016

Last Updated

August 15, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will share

Locations

IR(1)