Tokyo, July 29 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062367) titled 'A Study of How Often and Why Germs Briefly and Without Symptoms Enter the Blood During Nasal Tube Placement' on July 28.
Study Type:
Observational
Primary Sponsor:
Institute - Nagasaki University Hospital
Condition:
Condition - Patients scheduled to undergo orthognathic surgery (bimaxillary osteotomy or BSSO) under general anesthesia with nasotracheal intubation
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To clarify the frequency of bacterial DNA detection in arterial blood before and after nasotracheal intubation following standardized nasal decontamination in patients undergoing orthognathic surgery
Basic objectives2 - Safety,Efficacy
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1. Patients aged 18 years or older who are scheduled to undergo orthognathic surgery (bimaxillary osteotomy or mandibular osteotomy) under general anesthesia with nasotracheal intubation
2. Patients from whom written informed consent has been obtained
Key exclusion criteria - 1. Patients who require preoperative antimicrobial administration before entering the operating room, such as those at high risk of infective endocarditis
2. Patients who have received antimicrobial therapy within 7 days prior to surgery
3. Patients with overt immunosuppression (e.g., long-term corticosteroid use or ongoing chemotherapy)
4. Patients judged inappropriate for study participation by the attending physician or the investigator
Target Size - 100
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 05 Month 15 Day
Date of IRB - 2026 Year 05 Month 22 Day
Anticipated trial start date - 2026 Year 09 Month 01 Day
Last follow-up date - 2028 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071378
Disclaimer: Curated by HT Syndication.