Prevention of wound infections after colorectal surgery using antibiotics prior to surgery

Background

Colorectal surgery is frequently complicated by surgical site infections (SSIs). The main consequences of SSIs are prolonged hospitalization, increased risk of surgical reintervention and increased mortality. Perioperative intravenous antibiotic prophylaxis is a common strategy to reduce the risk of SSIs. Preoperative oral antibiotic prophylaxis (Pre-OP) has been suggested as an additional prophylaxis to further reduce the risk of infection. The main objective of the PreCaution trial is to evaluate the effectiveness of Pre-OP in addition to intravenous perioperative antibiotic prophylaxis in reducing the incidence of deep SSIs and/or mortality after elective colorectal surgery.



Methods / Design

The PreCaution trial is designed as a multicenter, double-blind, randomized, placebo-controlled clinical trial that will be carried out in Dutch hospitals. Adult patients who will undergo elective colorectal surgery and who do not meet any of the exclusion criteria are eligible to participate in the trial. A total number of 966 patients will be randomized to receive study medication, which will either be Pre-OP, consisting of tobramycin and colistin sulphate, or a placebo. The study medication will be administered four times daily during the last 3 days prior to surgery. Perioperative intravenous antibiotic prophylaxis will be administered to all patients in accordance with the national infection control guidelines. The primary endpoint of the study is the cumulative incidence of deep SSI and/or mortality within 30 days after surgery. Secondary endpoints include both infectious and non-infectious complications of colorectal surgery. The endpoints will be evaluated on postoperative day 30 and after completion of the 6-month follow-up period.



To conclude, the PreCaution trial will investigate whether Pre-OP in addition to intravenous perioperative antibiotic prophylaxis will reduce the risk of SSIs and mortality after elective colorectal surgery. The results of the trial will be of great value to enable evidence-based recommendations regarding the effect of Pre-OP on patient outcomes and healthcare costs.

It is hypothesized that a preoperative oral antibiotic prophylaxis, that is administered in addition to perioperative intravenous prophylaxis, will lead to a reduction in postoperative would infections after colorectal surgery

The endpoints will be evaluated on postoperative day 30 and after completion of the 6-month follow-up period.

Intervention

The intervention is a preoperative oral antibiotic prophylaxis (Pre-OP), which is a solution of colistin sulphate and tobramycin. Pre-OP is administered 4 times daily (5 mL per dose) during the last 3 days prior to surgery.



Control group

The control group receives a placebo without the active antimicrobial ingredients but with a similar taste and color.



All patients receive perioperative intravenous antibiotic prophylaxis in accordance with the national infection control guidelines.