Broad-spectrum antibiotic prophylaxis in tumor and infected orthopedic surgery-the prospective-randomized, microbiologist-blinded, stratified, superiority trials: BAPTIST Trials

• Published in: Current controlled trials in cardiovascular medicine Vol. 25; no. 1; p. 69
• Main Authors: Uçkay, Ilker, Bomberg, Hagen, Risch, Markus, Müller, Daniel, Betz, Michael, Farshad, Mazda
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 19.01.2024; BioMed Central; BMC
• Subjects: Antibiotic Prophylaxis - methods; Antibiotics; Back surgery; Bacteria; Bone surgery; Broad-spectrum antibiotic prophylaxis; Care and treatment; Cefuroxime; Complications and side effects; Disease prevention; Hospitalization; Humans; Microorganisms; Multidrug resistant organisms; Neoplasms - drug therapy; Neoplasms - surgery; Nosocomial infections; Nurses; Open fractures; Orthopedic Procedures - adverse effects; Orthopedic surgery; Orthopedics; Pathogens; Patient outcomes; Patients; Postoperative healthcare-associated infections; Prevention; Prospective Studies; Randomized-controlled trial; Skin; Staphylococcus infections; Surgeons; Surgical site infections; Surgical Wound Infection - etiology; Surgical Wound Infection - prevention & control; Transplants & implants; Tumors; Vancomycin - therapeutic use; Switzerland; Broad-spectrum antibiotic prophylaxis; Postoperative healthcare-associated infections; Randomized-controlled trial; Orthopedic surgery; Surgical site infections
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-023-07605-5

The perioperative antibiotic prophylaxis with 1st or 2nd generation cephalosporins is evidence-based in orthopedic surgery. There are, however, situations with a high risk of prophylaxis-resistant surgical site infections (SSI). We perform a superiority randomized controlled trial with a 10% margin and a power of 90% in favor of the broad-spectrum prophylaxis. We will randomize orthopedic interventions with a high risk for SSI due to selection of resistant pathogens (open fractures, surgery under therapeutic antibiotics, orthopedic tumor surgery, spine surgery with American Society of Anesthesiologists (ASA) score ≥ 3 points) in a prospective-alternating scheme (1:1, standard prophylaxis with cefuroxime versus a broad-spectrum prophylaxis of a combined single-shot of vancomycin 1 g and gentamicin 5 mg/kg parenterally). The primary outcome is "remission" at 6 weeks for most orthopedic surgeries or at 1 year for surgeries with implant. Secondary outcomes are the risk for prophylaxis-resistant SSI pathogens, revision surgery for any reason, change of antibiotic therapy during the treatment of infection, adverse events, and the postoperative healthcare-associated infections other than SSI within 6 weeks (e.g., urine infections or pneumonia). With event-free surgeries to 95% in the broad-spectrum versus 85% in the standard prophylaxis arm, we need 2 × 207 orthopedic surgeries. In selected patients with a high risk for infections due to selection of prophylaxis-resistant SSI, a broad-spectrum combination with vancomycin and gentamycin might prevent SSIs (and other postoperative infections) better than the prophylaxis with cefuroxime. ClinicalTrial.gov NCT05502380. Registered on 12 August 2022. Protocol version: 2 (3 June 2022).