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

NCT05253339 | Completed

• 1 other identifier: 2022-0180
• Study Type: interventional
• Target: 2,494
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• The incidence of surgical site infections

  Surgical site infection (SSI) is an infection that occurs after surgery in the part of the body where the surgery took place. Superficial incisional SSI occurs just in the area of the skin where the incision was made. Deep incisional SSI occurs beneath the incision area in muscle and the tissues surrounding the muscles. Organ-space SSI includes infections involving any part of the anatomy that was opened or manipulated during an operation

  Within 30 days after the operation

Secondary Outcomes (1)

• Total dose of cefoxitin

  on the day of surgery

Other Outcomes (1)

• The incidence of acute kidney injury

  Within 7 days after the operation

Study Arms (2)

Standard administration method

ACTIVE COMPARATOR

Drug: Cefoxitin, Device: not applicable (standard method) Two grams of cefoxitin (JW Pharmaceutical Co., Ltd., Seoul, South Korea) was dissolved in 50 mL of normal saline and administered for about 10 min before skin incision.

Procedure: Standard administration method

Target controlled infusion (TCI)

EXPERIMENTAL

Drug: Cefoxitin, Device: TCI Syringe pump Two grams of cefoxitin were dissolved in 50 mL of normal saline to give a concentration of 40 mg/mL. Before skin incision, cefoxitin was infused with a TCI syringe pump (Pilot Anesthesia 2, Fresenius vial, France), which was connected to a personal computer by an RS232c cable and controlled with TCI software (Asan pump, version 2.1.3; Bionet Co. Ltd., Seoul, Korea, http://www.fit4nm.org/download, last accessed: 27 August, 2012). Target concentrations of total concentrations were set to 80 μg/mL.

Procedure: target-controlled infusion (one of the administration methods)

Interventions

target-controlled infusion (one of the administration methods) PROCEDURE

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

Target controlled infusion (TCI)

Standard administration method PROCEDURE

Standard method of administering cefoxitin in the current clinical setting

Standard administration method

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• over 20 years old
• Patients who are scheduled to undergo colon or rectal surgery
• Patients scheduled to receive cefoxitin as a prophylactic antibiotic

You may not qualify if:

• 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

Sponsors & Collaborators

• Asan Medical Center: lead
• Seoul Business Agency: collaborator

Study Sites (1)

Asan Medical Center

Seoul, Songpa-Gu,, 05505, South Korea

Location

Related Publications (1)

• Kim HJ, Kim KM, Lee JL, Park IJ, Choi BM. A single-centre randomised 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: study protocol. Trials. 2025 Jan 8;26(1):11. doi: 10.1186/s13063-025-08716-x.

  PMID: 39780190 DERIVED

Study Officials

• Byung-Moon Choi, Ph.D.

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Only the patient is blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: When administering cefoxitin, the standard administration method and the target concentration control injection method are randomly assigned 1:1.

Study Record Dates

• First Submitted: February 14, 2022
• First Posted: February 23, 2022
• Study Start: April 4, 2022
• Primary Completion: August 28, 2025
• Study Completion: August 28, 2025
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)