Tokyo, Aug. 29 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062729) titled 'Sustained Antimicrobial Efficacy of Silver-Ion/Hydrogen Peroxide versus Quaternary Ammonium on High-Touch Operating Room Surfaces: A Multicenter Randomized Controlled Trial' on Aug. 28.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -but assessor(s) are blinded Control - Active

Primary Sponsor: Institute - Birjand University of Medical Sciences

Condition: Condition - Microbial contamination of high-touch operating room surfaces Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To compare the immediate and sustained antimicrobial efficacy of hydrogen peroxide stabilized with silver ions (HP-Ag) versus quaternary ammonium compounds (QACs) on high-touch operating room surfaces, and secondarily to explore their association with 30-day postoperative surgical site infection rates. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Hydrogen peroxide stabilized with silver ions (HP-Ag): High-touch operating room surfaces were pre-cleaned using disposable detergent-impregnated wipes and then disinfected with a ready-to-use 2% hydrogen peroxide solution stabilized with 10 ppm silver ions. The disinfectant was applied using sterile microfiber towels in a standardized S-shaped wiping pattern with a minimum wet contact time of 1 minute. One disinfection session was performed for each randomized operating room, followed by environmental monitoring for 4 hours. Interventions/Control_2 - Quaternary ammonium compound (QAC): High-touch operating room surfaces were pre-cleaned using disposable detergent-impregnated wipes and then disinfected with a hospital-grade quaternary ammonium compound containing alkyl dimethyl benzyl ammonium chloride (ADBAC) and didecyl dimethyl ammonium chloride (DDAC) at an in-use concentration of 400 ppm. The disinfectant was applied using sterile microfiber towels in a standardized S-shaped wiping pattern with a minimum wet contact time of 1 minute. One disinfection session was performed for each randomized operating room, followed by environmental monitoring for 4 hours.

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Adult patients aged 18 years or older. 2. Undergoing elective, clean surgical procedures in randomized operating rooms. 3. Eligible procedures: laparoscopic cholecystectomy, mesh inguinal hernia repair, umbilical hernia repair, small ventral hernia repair, non-perforated laparoscopic appendectomy, or thyroidectomy. 4. ASA physical status I or II. 5. Operative duration strictly between 60 and 120 minutes. 6. Receipt of standardized antimicrobial prophylaxis and standardized skin antisepsis. Key exclusion criteria - 1. Contaminated surgical wound. 2. Emergency surgery. 3. Active systemic or localized infection. 4. Immunocompromised status. 5. Uncontrolled diabetes mellitus. 6. Pregnancy. 7. Previous surgical intervention in the same anatomical region. Target Size - 400

Recruitment Status: Recruitment status - Completed Date of protocol fixation - 2024 Year 12 Month 15 Day Date of IRB - 2024 Year 12 Month 30 Day Anticipated trial start date - 2025 Year 01 Month 01 Day Last follow-up date - 2025 Year 08 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071826

Disclaimer: Curated by HT Syndication.