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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 Infection

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 Infection

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-000675-15-GB
Enrollment
500
Registered
2006-09-18
Start date
2006-09-11
Completion date
Unknown
Last updated
2020-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Potential Systematic Sepsis

Interventions

Trade Name: Betadine Alcoholic Solution Product Name: Povidone-iodine Pharmaceutical Form: Cutaneous solution Trade Name: Hydrex Pink Chlorhexidine Gluconate Product Name: Chlorhexidine Gluconate Sol

Sponsors

Great Ormond Street Hospital for Children NHS Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria: Previous allergy to either skin preparation would exclude participation

Design outcomes

Primary

MeasureTime frame
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.—

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026