Prophylactic Antibiotics in Preventing Surgical Site Infection After Hepatobiliary Surgery in Hig… (NCT07620223) | Clinical Trial Compass
RecruitingNot Applicable
Prophylactic Antibiotics in Preventing Surgical Site Infection After Hepatobiliary Surgery in High-Resistant Settings
China378 participantsStarted 2026-05-24
Plain-language summary
To analyse the efficacy of different preoperative prophylactic antimicrobial regimens for perioperative infection prevention in patients undergoing hepatobiliary surgery in a high antimicrobial resistance setting.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adult patients aged ≥18 years;
* Deemed eligible for elective hepatobiliary surgery;
* Demonstrated comprehension of the study nature and expressed willingness to comply with trial procedures;
* Capable of providing written informed consent.
Exclusion Criteria:
* History of β-lactam allergy or hypersensitivity
* Uncontrolled preoperative infection;
* Current or recent (within the preceding month) systemic corticosteroid administration;
* Severe hepatic or renal impairment;
* Pregnancy or lactation;
* Concurrent enrolment in another clinical trial;
* Any other condition deemed by the investigator to render the patient unsuitable for study participation.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial is specifically about preventing surgical site infections after hepatobiliary surgery, would I be considered a good candidate to discuss based on the type of liver or bile duct surgery I'm having?
2The trial is set in 'high-resistant' settings, which I think refers to bacteria that are hard to treat with standard antibiotics — can you explain what that means for my situation and whether that's a concern at the hospital where I'd be treated?
3This study is measuring whether prophylactic antibiotics actually reduce infections within 30 days after surgery — does that mean the current standard approach at this hospital isn't already well-established, and how might that affect my care if I participate?
4Since this trial is listed as Phase NA, which sometimes applies to studies testing practices rather than new drugs, can you explain what exactly would be different about my antibiotic treatment compared to what I'd receive outside the trial?
5Would joining this trial affect the timing of my surgery or require extra follow-up visits over those 30 days, and is that something that would realistically work with my schedule and recovery plan?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with surgical site infection within 30 days after surgery
Timeframe: 30 days after the surgery
Trial details
NCT IDNCT07620223
SponsorThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School