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The Expected Advantage of Administering Prophylactic Antibiotics Using Target- Concentration Controlled Infusion

NCT05253339 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2494

Last updated 2025-09-25

No results posted yet for this study

Summary

Preoperative antimicrobial prophylaxis is a key element for the prevention of surgical site infection, the most common type of nosocomial infection in surgical patients. Prophylactic antibiotics are selected depending on the type of surgery, and first- or second-generation cephalosporins have been mainly used. Cefoxitin, a second-generation cephalosporin with anaerobic activity, has been used in various clinical settings as a prophylactic antibiotic for colorectal surgery. Cefoxitin is generally dissolved in normal saline and intravenously administered for a short time of 5-10 minutes before skin incision. However, there are several drawbacks to the current dosing strategy. First, the dose of cefazolin is determined by a "rule of thumb", and there is controversy over whether 1 g or 2 g is appropriate, with the opinion that 2 g being more appropriate prevailing. Second, the standard administration method unnecessarily induces a concentration higher than the concentration required to prevent surgical site infection. Third, significant covariates that can affect the maintenance of MIC during surgery are not considered. The target-concentration controlled infusion (TCI) method can be a viable alternative administration method for antibiotics. The TCI method enables individual customized administration according to the covariates (i.e., weight, creatinine clearance) included in the pharmacokinetic parameters; also, although with some variability, the drug can be administered while maintaining the target concentration. The aim of this study was to evaluate the effectiveness of administering cefoxitin in patients undergoing colorectal surgery with a syringe pump equipped with a target concentration control injection function

Conditions

  • Anti-bacterial Agents
  • Pharmacokinetics
  • General Surgery

Interventions

PROCEDURE

target-controlled infusion (one of the administration methods)

a method of administering cefoxitin while maintaining a constant target concentration.

PROCEDURE

Standard administration method

Standard method of administering cefoxitin in the current clinical setting

Sponsors & Collaborators

  • Seoul Business Agency

    collaborator UNKNOWN

  • Asan Medical Center

    lead OTHER

Principal Investigators

  • Byung-Moon Choi, Ph.D. · Asan Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-04
Primary Completion
2025-08-28
Completion
2025-08-28

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05253339 on ClinicalTrials.gov