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Efficacy and safety of olanexidine gluconate for skin disinfection of blood culture collection

Efficacy and safety of olanexidine gluconate for skin disinfection of blood culture collection: a single-arm, open-label trial

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs061220073
Enrollment
215
Registered
2022-12-05
Start date
2023-02-02
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Infections Infections, Sepsis, Bacteremia

Interventions

Disinfect the puncture site with 1.5% oranexidine once for 30 seconds before collecting blood culture.
Anti-Infective Agents
disinfection, sterilization

Sponsors

Ota Kohei
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. over 18 years 2. Patients from whom blood culture was collected in the emergency department or the intensive care unit 3. Provision of written informed consent from patients or their surrogate

Exclusion criteria

Exclusion criteria: 1. History of allergy or contact dermatitis caused by 1.5% oranexidine (for those who have already been enrolled in this study, including those who have been found to have adverse events in this study for which a causal relationship with 1.5% oranexidine cannot be denied.) 2. Patients with systemic skin diseases 3. Patients with wound or skin ulcer at the puncture site 4. Patients whose puncture site is contaminated with feces, urine, or sludge, and who require procedures other than disinfection such as wiping. 5. Patients who have received antimicrobial agents with antimicrobial activity against contaminating bacteria.

Design outcomes

Primary

MeasureTime frame
Contamination rate of blood culture samples

Secondary

MeasureTime frame
Comparison of contamination rates by site of blood collection, volume of blood collected, provider of blood collection, and severity (APACHE [acute physiology and chronic health evaluation] II score, SOFA [sequential organ failure assessment] score) Safety endpoints: Adverse events (contact dermatitis, anaphylaxis, other)

Contacts

Public ContactKohei Ota

Hiroshima University Hospital

kota@hiroshima-u.ac.jp+81-82-257-5456

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026