Open label Randomised Controlled Trial comparing povidone-iodine 10% with alcohol and 0.5% chlorhexidine with alcohol for prevention of early infection associated with insertion of central venous access devices - RCT for the prevention of early CVAD Infectio

Phase 1

• Conditions: Potential Systematic Sepsis

• Registration Number: EUCTR2006-000675-15-GB
• Lead Sponsor: Great Ormond Street Hospital for Children NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-09-18
• Last Update Posted: 27 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

All children aged between newborn and 16 years and requiring insertion of a tunnelled central venous access device will be eligible for inclusion

Some young adults aged between 16-20 years may also require insertion of tunnelled central venous access device, they will also be eligible for inclusion. In special circumstances if these young adults are not able to consent for him or herself their legal guardian will consent on their behalf.

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Previous allergy to either skin preparation would exclude participation

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The purpose of this study is to compare the efficacy of skin antisepsis with 10% povidone-iodine with alcohol with that of 0.5% chlorhexidine with 70% alcohol for the prevention of infection related to the insertion of central venous access devices. ;Secondary Objective: ;Primary end point(s): Absence or presence of sepsis by day 30 of application of antiseptic solution.