NCT02263196

Brief Summary

The purpose of this study was to compare the efficacy of combination of alcohol and povidone iodine 10% and Alcohol 70% after povidone iodine 10% on inflammation and infection related to vascular access area in hemodialysis patients.

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
96

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2014

Shorter than P25 for phase_1

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

September 1, 2014

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

September 26, 2014

Completed
17 days until next milestone

First Posted

Study publicly available on registry

October 13, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

April 8, 2015

Status Verified

April 1, 2015

Enrollment Period

8 months

First QC Date

September 26, 2014

Last Update Submit

April 7, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • effected of betadin and alcohol on inflammation and infection of the patient

    up to one month

Study Arms (2)

alcohol and povidone iodine

EXPERIMENTAL

the efficacy of combination of alcohol and povidone iodine on inflammation related to vascular access

Other: Alcohol and povidone iodine

combination of alcohol and betadin

EXPERIMENTAL

the efficacy of combination of alcohol and povidone iodine on infection related to vascular access

Other: combination of alcohol and betadin

Interventions

using from Alcohol and povidone iodine for prevention of inflammation

alcohol and povidone iodine

using from combination Alcohol and povidone iodine for prevention of inflammation

combination of alcohol and betadin

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • absence of inflammatory vascular access site
  • three dialysis sessions per week

You may not qualify if:

  • patient dies
  • patient withdrew from the partnership

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ali Bazzi

Mashhad, Iran

RECRUITING

Related Publications (1)

  • Branas P, Morales E, Rios F, Sanz F, Gutierrez E, Quintanilla N, Orellana MA, Sanchez M, Rodriguez-Aranda A, Chaves F. Usefulness of endoluminal catheter colonization surveillance cultures to reduce catheter-related bloodstream infections in hemodialysis. Am J Infect Control. 2014 Nov;42(11):1182-7. doi: 10.1016/j.ajic.2014.07.022. Epub 2014 Sep 22.

    PMID: 25248485BACKGROUND

Related Links

MeSH Terms

Interventions

EthanolPovidone-Iodine

Intervention Hierarchy (Ancestors)

AlcoholsOrganic ChemicalsIodophorsIodine CompoundsInorganic ChemicalsPolyvinylsVinyl CompoundsAlkenesHydrocarbons, AcyclicHydrocarbonsPovidonePyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPlasticsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • mohmmad rajabpoor, student

    Msc Student, Faculty of Nursing and Midwifery

    PRINCIPAL INVESTIGATOR

Central Study Contacts

ali bazzi, MSc student

CONTACT

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mashhad University of Medical Sciences

Study Record Dates

First Submitted

September 26, 2014

First Posted

October 13, 2014

Study Start

September 1, 2014

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

April 8, 2015

Record last verified: 2015-04

Locations