Using targeted infusion for antibiotic administration before surgery
A Single-center Randomized Controlled Trial Comparing the Standard Method and Target-controlled Infusion as a Method of Administering Cefoxitin, Which is Used to Prevent Surgical Site Infections in Colorectal Surgical Patients
This study is testing if giving antibiotics through a special infusion before colon or rectal surgery can help prevent infections by better matching the dose to each patient's needs.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 2494 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | Asan Medical Center Academic / other |
| Locations | 1 site (Seoul, Songpa-Gu,) |
| Trial ID | NCT05253339 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of administering prophylactic antibiotics through a target-controlled infusion method prior to colon or rectal surgery. The aim is to optimize antibiotic dosing based on individual patient characteristics such as body weight and renal function, addressing issues with the current standard administration method that may lead to excessively high drug concentrations. By tailoring the infusion to maintain appropriate plasma levels, the study seeks to enhance the safety and efficacy of antibiotic prophylaxis in preventing surgical site infections. Participants will receive cefoxitin, a second-generation cephalosporin, as part of their preoperative care.
Who should consider this trial
Good fit: Ideal candidates are adults over 20 years old scheduled for colon or rectal surgery who will receive cefoxitin as a prophylactic antibiotic.
Not a fit: Patients with known allergies to cefoxitin, those receiving therapeutic antibiotics, or those with significantly impaired renal function may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved safety and reduced risk of surgical site infections for patients undergoing colorectal surgery.
How similar studies have performed: While the concept of targeted infusion is established, this specific approach to antibiotic administration in surgical settings is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * over 20 years old * Patients who are scheduled to undergo colon or rectal surgery * Patients scheduled to receive cefoxitin as a prophylactic antibiotic Exclusion Criteria: * Known allergies, hypersensitivity, or intolerance to cefoxitin * Patients with a history of receiving cefoxitin within 3 days of the scheduled surgery time * Patients receiving therapeutic antibiotics * eGFR \< 30 ml/min/1.73m2
Where this trial is running
Seoul, Songpa-Gu,
- Asan Medical Center — Seoul, Songpa-Gu,, Korea, Republic of (Recruiting)
Study contacts
- Principal investigator: Byung-Moon Choi, Ph.D. — Asan Medical Center
- Study coordinator: Byung-Moon Choi, Ph.D.
- Email: byungmoonchoi7@gmail.com
- Phone: 82230101704
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.