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

Phase 1

• Conditions: Complication of Hemodialysis
• Interventions: Other: Alcohol and povidone iodine; Other: combination of alcohol and betadin

• Registration Number: NCT02263196
• Lead Sponsor: Mashhad University of Medical Sciences

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.

Detailed 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.

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-09-26
• Study First Submitted QC: 2014-10-08
• Study First Posted: 2014-10-13
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-07
• Last Update Posted: 2015-04-08
• Primary Completion: 2015-05
• Study Completion: 2015-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

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

Exclusion Criteria

• patient dies
• patient withdrew from the partnership

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
alcohol and povidone iodine	Alcohol and povidone iodine	the efficacy of combination of alcohol and povidone iodine on inflammation related to vascular access
combination of alcohol and betadin	combination of alcohol and betadin	the efficacy of combination of alcohol and povidone iodine on infection related to vascular access

Primary Outcome Measures

Name	Time	Method
effected of betadin and alcohol on inflammation and infection of the patient	up to one month

Trial Locations

Locations (1)

Ali Bazzi; 🇮🇷 Mashhad, Iran, Islamic Republic of