The Efficacy of Alcohol After Betadine and Combination of Alcohol and Betadine on Inflammation Vascular Access

Complication of Hemodialysis Clinical Trial

Official title:

Mashhad University of Medical Sciences

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02263196
• Other study ID #: 921839
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: September 26, 2014
• Last updated: April 7, 2015
• Start date: September 2014
• Est. completion date: May 2015

Study information

• Verified date: April 2015
• Source: Mashhad University of Medical Sciences
• Contact: ali bazzi, MSc student
• Phone: 09113723582
• Email: bazzia911[@]mums.ac.ir
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Description:

These cases were identified from patient that lack of specific diseases; Non-use of antibiotics or immunosuppressive drugs. That the participants will be selected using convenience sampling method and randomly divided into three groups: combination of alcohol and povidone iodine 10%, Alcohol after and control groups. In the Intervention in one group the vascular access site disinfected with Alcohol(group1) and in group 2, Alcohol and povidone iodine 10% was used to separate were disinfected. Then the patient in a month of inflammation and infection of the vascular access will be monitor. Exclusion criteria: inflammation or fistula failure during the study for any reason other than infection. Sample size determination: Through the pilot study. Date: 02.10.2014 till 02.11.2014 Outcome: Washing with both solution affected on reduce the inflammation and infection of the patient.

the efficacy of Alcohol after Betadine and combination of alcohol and Betadine on inflammation and infection related to Vascular access hemodialysis patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• absence of inflammatory vascular access site

• three dialysis sessions per week

Exclusion Criteria:

• patient dies

• patient withdrew from the partnership

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Complication of Hemodialysis

Intervention

Other:
• Alcohol and povidone iodine
using from Alcohol and povidone iodine for prevention of inflammation
• combination of alcohol and betadin
using from combination Alcohol and povidone iodine for prevention of inflammation

Locations

Country	Name	City	State
Iran, Islamic Republic of	Ali Bazzi	Mashhad

Sponsors (1)

Lead Sponsor	Collaborator
Mashhad University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

References & Publications (1)

Brañas P, Morales E, Ríos F, Sanz F, Gutiérrez E, Quintanilla N, Orellana MA, Sánchez M, Rodríguez-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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	effected of betadin and alcohol on inflammation and infection of the patient		up to one month	Yes

External Links

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