1. In this randomized controlled trial, oral antimicrobial prophylaxis was reported to trim the incidence of surgical tract infections (SSI) erstwhile compared to a placebo successful patients undergoing elective colorectal surgery.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Surgical tract corruption (SSI) is 1 of the astir communal healthcare-related infections, particularly successful patients undergoing colorectal country with reported incidence rates of SSI up to 26%. Current guidelines urge intravenous antimicrobial therapy against some aerobic and anaerobic bacteria to forestall SSI pursuing colorectal surgery. The efficacy of oral antimicrobial therapy has been studied, and a caller meta-analysis reported a simplification of SSI by much than 50%, but existent existing grounds remains rather limited. This survey is simply a multicenter, randomized, double-blind, placebo controlled proceedings that was conducted successful 11 sites successful France. Patients were randomized successful a 1:1 ratio to person either a 1g dose of ornidazole oregon a placebo anterior to surgery. Otherwise, each patients received a 2nd procreation cephalosporin with anaerobic enactment (cefoxitin 2g) astatine slightest 30 minutes earlier tegument incision arsenic well, and intraoperatively if the process lasted 2 hours oregon longer pursuing existent guidelines. Included were patients scheduled for elective laparoscopic oregon unfastened colorectal surgery. The superior result analyzed successful this survey was immoderate SSI wrong 30 days aft surgery, including superficial incisional, heavy incisional, oregon organ abstraction infections. Secondary outcomes included stratification of SSI type, arsenic good arsenic different postoperative complications. Between May 2016 and August 2019, 926 patients were randomized, with 463 patients receiving ornidazole and 463 patients receiving a placebo. With respect to the superior outcome, the complaint of SSI wrong 30 days aft country was importantly little successful the oral prophylaxis radical compared to the placebo group; the incidence of SSI was 13% (60/463) successful the oral prophylaxis group, and 21.6% (100/463) successful the placebo radical (ARR 0.62, 95% CI 0.44-0.46, P=.001). Concerning secondary outcomes, important differences were reported successful heavy and organ abstraction infections, large complications wrong 30 days aft surgery, and sepsis oregon septic shock. Of note, determination was nary important quality betwixt the 2 groups successful decease astatine 30 days. The findings from this survey suggest that adding a azygous dose of 1g of ornidazole 12 hours earlier country arsenic an adjunct to intravenous antibiotics resulted successful a importantly little complaint of SSI compared to a placebo. A large spot of this survey is the ample illustration size; however, limitations see the usage of cefoxitin limiting outer validity fixed expanding anaerobic absorption and decreased generalization of results to excluded diligent populations who often necessitate colorectal country including patients with inflammatory bowel disease. This survey is an important measurement towards reducing the highly precocious incidence rates of SSI, particularly successful elective colorectal surgery, and developments successful antimicrobial prophylaxis volition pb to decreases successful diligent morbidity and associated healthcare costs.
Click to work the survey successful BMJ
Relevant Reading: Strategies for Antibiotic Administration for Bowel Preparation Among Patients Undergoing Elective Colorectal Surgery
In-Depth [randomized controlled trial]: This survey analyzed the narration of oral antimicrobial prophylaxis versus placebo successful preventing SSIs successful patients undergoing elective colorectal surgery. Included successful the investigation were patients undergoing elective colorectal country successful 1 of 11 sites successful France, and excluded were patients with a concomitant surgical procedure, an progressive bacterial corruption oregon caller antimicrobial use, inflammatory bowel disease, a known allergy to antibiotics, known chronic kidney disease, and who were breastfeeding oregon were pregnant. 926 patients were randomized successful a 1:1 ratio to person a placebo oregon oral antimicrobial prophylaxis, with 463 (50%) patients successful each group. Baseline characteristics were akin betwixt the 2 groups, but for the placebo radical having much men and patients with coronary artery disease. 593 patients (64%) underwent colon resection, and 333 patients (36%) underwent rectal resection. 685 (74%) procedures were performed laparoscopically. Concerning the superior result studied, patients who received oral antimicrobial prophylaxis had a importantly little complaint of SSI compared to the placebo radical (P=.001). In presumption of secondary outcomes, important differences existed for heavy incisional corruption (4.8% vs 8.0%; RR 0.54, 95% CI 0.31-0.92; P=.03), organ abstraction infections (5.0% v 8.4%; RR 0.53, 95% CI 0.31-0.91; P=.02), large complications (RR 0.67, 95% CI 0.46-0.95; P=.03), and sepsis oregon septic daze (P=.046). Of note, determination was nary important quality betwixt the 2 groups for decease wrong 30 days (P=.27). Overall, this randomized controlled proceedings suggests that oral antimicrobial prophylaxis resulted successful reduced rates of SSI successful patients undergoing elective colorectal surgery.
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