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

• Sponsor: Mashhad University of Medical Sciences (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02263196
• Collaborator: (none)
• Enrollment: 96
• Location: 1
• Arms: 2
• Duration (Months): 8
• Patients Per Site Per Month: 12.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Complication of Hemodialysis	Other: Alcohol and povidone iodine; Other: combination of alcohol and betadin	Phase 1/Phase 2

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 96 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Prevention
• Official Title: Mashhad University of Medical Sciences
• Study Start Date: Sep 1, 2014
• Anticipated Primary Completion Date: May 1, 2015
• Anticipated Study Completion Date: May 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: alcohol and povidone iodine the efficacy of combination of alcohol and povidone iodine on inflammation related to vascular access	Other: Alcohol and povidone iodine; using from Alcohol and povidone iodine for prevention of inflammation
Experimental: combination of alcohol and betadin the efficacy of combination of alcohol and povidone iodine on infection related to vascular access	Other: combination of alcohol and betadin; using from combination Alcohol and povidone iodine for prevention of inflammation

Outcome Measures

Primary Outcome Measures

1. effected of betadin and alcohol on inflammation and infection of the patient [up to one month]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• absence of inflammatory vascular access site

• three dialysis sessions per week

Exclusion Criteria:

• patient dies

• patient withdrew from the partnership

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ali Bazzi	Mashhad		Iran, Islamic Republic of

Sponsors and Collaborators

• Mashhad University of Medical Sciences

Investigators

• Principal Investigator: mohmmad rajabpoor, student, Msc Student, Faculty of Nursing and Midwifery

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• that is a article from pubmed

Publications

• 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.

• Responsible Party: rajabpoor, Mashhad University of Medical Sciences, Mashhad University of Medical Sciences
• ClinicalTrials.gov Identifier: NCT02263196
• Other Study ID Numbers: 921839
• First Posted: Oct 13, 2014
• Last Update Posted: Apr 8, 2015
• Last Verified: Apr 1, 2015

• Additional relevant MeSH terms: Ethanol; Povidone-Iodine; Povidone

Study Results

No Results Posted as of Apr 8, 2015