Broad-spectrum antibiotic prophylaxis in tumor and infected orthopedic surgery—the prospective-randomized, microbiologist-blinded, stratified, superiority trials: BAPTIST Trials
Abstract Background 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). Methods We perform a superiority randomized control...
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| Format: | Article |
| Language: | English |
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BMC
2024-01-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-023-07605-5 |
| _version_ | 1797349698535686144 |
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| author | Ilker Uçkay Hagen Bomberg Markus Risch Daniel Müller Michael Betz Mazda Farshad |
| author_facet | Ilker Uçkay Hagen Bomberg Markus Risch Daniel Müller Michael Betz Mazda Farshad |
| author_sort | Ilker Uçkay |
| collection | DOAJ |
| description | Abstract Background 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). Methods 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. Discussion 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. Trial registration ClinicalTrial.gov NCT05502380. Registered on 12 August 2022. Protocol version: 2 (3 June 2022) |
| first_indexed | 2024-03-08T12:34:09Z |
| format | Article |
| id | doaj.art-26644bfabe5c4aa3b3155b98679958fb |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-03-08T12:34:09Z |
| publishDate | 2024-01-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-26644bfabe5c4aa3b3155b98679958fb2024-01-21T12:33:51ZengBMCTrials1745-62152024-01-0125111110.1186/s13063-023-07605-5Broad-spectrum antibiotic prophylaxis in tumor and infected orthopedic surgery—the prospective-randomized, microbiologist-blinded, stratified, superiority trials: BAPTIST TrialsIlker Uçkay0Hagen Bomberg1Markus Risch2Daniel Müller3Michael Betz4Mazda Farshad5Department of Orthopedic Surgery, Balgrist University Hospital, University of ZurichDepartment of Anesthesiology, Intensive Care and Pain Medicine, Balgrist University Hospital, University of ZurichDepartment of Anesthesiology, Intensive Care and Pain Medicine, Balgrist University Hospital, University of ZurichDepartment of Orthopedic Surgery, Balgrist University Hospital, University of ZurichDepartment of Orthopedic Surgery, Balgrist University Hospital, University of ZurichDepartment of Orthopedic Surgery, Balgrist University Hospital, University of ZurichAbstract Background 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). Methods 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. Discussion 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. Trial registration ClinicalTrial.gov NCT05502380. Registered on 12 August 2022. Protocol version: 2 (3 June 2022)https://doi.org/10.1186/s13063-023-07605-5Orthopedic surgeryBroad-spectrum antibiotic prophylaxisSurgical site infectionsPostoperative healthcare-associated infectionsRandomized-controlled trial |
| spellingShingle | Ilker Uçkay Hagen Bomberg Markus Risch Daniel Müller Michael Betz Mazda Farshad Broad-spectrum antibiotic prophylaxis in tumor and infected orthopedic surgery—the prospective-randomized, microbiologist-blinded, stratified, superiority trials: BAPTIST Trials Trials Orthopedic surgery Broad-spectrum antibiotic prophylaxis Surgical site infections Postoperative healthcare-associated infections Randomized-controlled trial |
| title | Broad-spectrum antibiotic prophylaxis in tumor and infected orthopedic surgery—the prospective-randomized, microbiologist-blinded, stratified, superiority trials: BAPTIST Trials |
| title_full | Broad-spectrum antibiotic prophylaxis in tumor and infected orthopedic surgery—the prospective-randomized, microbiologist-blinded, stratified, superiority trials: BAPTIST Trials |
| title_fullStr | Broad-spectrum antibiotic prophylaxis in tumor and infected orthopedic surgery—the prospective-randomized, microbiologist-blinded, stratified, superiority trials: BAPTIST Trials |
| title_full_unstemmed | Broad-spectrum antibiotic prophylaxis in tumor and infected orthopedic surgery—the prospective-randomized, microbiologist-blinded, stratified, superiority trials: BAPTIST Trials |
| title_short | Broad-spectrum antibiotic prophylaxis in tumor and infected orthopedic surgery—the prospective-randomized, microbiologist-blinded, stratified, superiority trials: BAPTIST Trials |
| title_sort | broad spectrum antibiotic prophylaxis in tumor and infected orthopedic surgery the prospective randomized microbiologist blinded stratified superiority trials baptist trials |
| topic | Orthopedic surgery Broad-spectrum antibiotic prophylaxis Surgical site infections Postoperative healthcare-associated infections Randomized-controlled trial |
| url | https://doi.org/10.1186/s13063-023-07605-5 |
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