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

JRCT ID: jRCTs061220073

Registered date:05/12/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Infections
• Date of first enrollment: 05/12/2022
• Target sample size: 215
• Study type: Interventional
• Intervention(s): Disinfect the puncture site with 1.5% oranexidine once for 30 seconds before collecting blood culture.

Outcome(s)

• Primary Outcome: Contamination rate of blood culture samples

Secondary Outcome

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)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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.

Related Information

• Primary Sponsor: Ota Kohei
• Source(s) of Monetary Support: Hiroshima Rotary Club