Tokyo, April 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000057764) titled 'The effectiveness of Antiseptic solution for Prevention of intravenous catheter-related blood stream infection with OLanexidine gLucOnate and chlorhexidine containing dressing -Apollo study 2-' on April 1.

Study Type: Interventional

Study Design: Basic Design - Factorial Randomization - Randomized Blinding - Open -no one is blinded Control - Active

Primary Sponsor: Institute - Jichi Medical University Saitama Medical Center

Condition: Condition - Patients aged 18 years or older who are admitted to acute care hospitals (defined as hospitals with ICU, HCU, or equivalent wards [such as those receiving emergency medical care management fees]) Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The purpose of this study is to verify the non-inferiority of 1.5% olanexidine gluconate solution compared to 1% chlorhexidine alcohol in peripherally inserted central catheter-related bloodstream infection occurrence, and the superiority of chlorhexidine-containing dressings (2*2 factorial design). Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - 1.5% olanexidine gluconate solution (Olanedine):Olanedine solution 1.5% antiseptic applicator 10ml (Otsuka Pharmaceutical Factory, Inc.) + chlorhexidine-containing dressing (CHG dressing)*3M Tegaderm CHG Dressing (3M Japan) Interventions/Control_2 - 1.5% olanexidine gluconate solution (Olanedine): Olanedine solution 1.5% antiseptic applicator 10ml (Otsuka Pharmaceutical Factory, Inc.) + polyurethane dressing:3M Tegaderm Transparent Dressing (3M Japan)

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Peripherally Inserted Central Catheter inserted in patients aged 18 years or older who are admitted to acute care hospitals (defined as hospitals with ICU, HCU, or equivalent wards [such as those receiving emergency medical care management fees]) Key exclusion criteria - 1. Patients with allergies to antiseptics 2. Cases where consent could not be obtained from the subject or their close relatives 3. Patients with systemic skin diseases 4. Cases with skin ulcers at the wound site 5. Patients using antimicrobial catheters 6. Patients participating in intervention trials related to CRBSI prevention (e.g., dressing formulations, skin antiseptics, antimicrobial catheters, antimicrobial administration, etc.) 7. Cases deemed difficult to obtain consent, such as in emergencies Target Size - 1600

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 05 Month 01 Day Anticipated trial start date - 2026 Year 07 Month 01 Day Last follow-up date - 2030 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066015

Disclaimer: Curated by HT Syndication.