Background
Prophylactic parenteral administration of antibiotics, particularly cefoxitin, is recommended to prevent surgical site infection (SSI) in colorectal surgery. The standard method involves administering a fixed dose quickly before skin incision, aiming to maintain the unbound concentration above the minimum inhibitory concentration (fT > MIC) during surgery. The target-controlled infusion (TCI) method, which adjusts the infusion rate based on the patient's physical characteristics, is hypothesized to better maintain fT > MIC.
Methods
This prospective, single-centre, parallel-arm, single-blinded, randomised controlled trial enrolled 2494 patients scheduled for colon or rectal surgery. Patients were randomized to either the control group (standard administration method) or the study group (TCI method). The control group received 2 g of cefoxitin dissolved in 100 ml of normal saline, administered over approximately 10 minutes, with redosing every 2 hours. The study group received 2 g of cefoxitin dissolved in 50 ml of normal saline, administered via a TCI syringe pump at a target concentration of 80 μg/ml until the end of surgery. Both groups received an additional 2 g of cefoxitin 12 hours post-surgery using the standard method.
Outcomes
The primary outcome was the incidence of SSI, with the secondary outcome being the administered dose of cefoxitin. Data collection included preoperative, intraoperative, and postoperative metrics.
Discussion
The study aims to provide evidence on the effectiveness of the TCI method in maintaining fT > MIC compared to the standard method, potentially offering a more personalized approach to antibiotic administration. The TCI method's ability to adjust dosing based on patient characteristics could lead to improved patient safety and efficacy in preventing SSI.
Limitations
Challenges include the inability to measure actual unbound concentrations in the TCI group and the necessity of using the standard method for additional doses post-surgery due to equipment limitations. Despite these, the study anticipates that the TCI method will demonstrate advantages over the standard administration method in preventing SSI.
This research contributes to the ongoing exploration of optimized antibiotic administration strategies in surgical settings, with the potential to significantly impact patient outcomes in colorectal surgery.
