Clinical trial · Interventional
Broad-spectrum Antibiotic Prophylaxis in Tumor and Infected Orthopedic Surgery
Broad-spectrum Antibiotic Prophylaxis in Tumor and Infected Orthopedic Sur-gery - the Prospective-randomized, Microbiologist-blinded, Stratified, Superiority Trials - BAPTIST Trials
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The perioperative antibiotic prophylaxis is evidence-based in orthopedic surgery. While its duration ranges from a single dose to three doses throughout the world, the choice of the prophylactic agents is undisputed. Worldwide, the surgeons use 1st or 2nd-generation cephalosporins (or vancomycin in some cases). However, there are particular clinical situation with a high risk of antibiotic-resistant surgical site infections (SSI); independently of the duration of adminis-tered prophylaxis. These resistant SSI's occur in contaminated wounds, or during surgery under current therapeutic antibiotics, and base on "selection" by antibiotics used for therapy or for prophylaxis.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Antibiotic Resistant Infection | — | UNRESOLVED | — |
| Microbial Colonization | — | UNRESOLVED | — |
| Surgical Site Infection | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Standard antibiotic prophylaxis | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Standard prophylaxis arm
- description
- The standard prophylaxis consists of one to three intravenous doses of cefuroxime 1.5 g intravenously; or cefuroxim 3g if obesity \> 120 kg or a BMI \> 35 kg/m2; or vancomycin 1 g or clindamycin 600 mg in case of intolerance to cephalosporins In patients alrady under current therapuetic antibiotic therapy, continuation of that therapuetic antibiotic regimen
- interventionNames
- Drug: Standard antibiotic prophylaxis
- type
- EXPERIMENTAL
- label
- Innovative prophylaxis arm
- description
- Additional single-shot perioperative antibiotic prophylaxis with Broad-spectrum prophylaxis: vancomycin 1 g \& gentamicin 5 mg/kg.
- interventionNames
- Drug: Standard antibiotic prophylaxis
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria * Age ≥ 18 years * Surgery under current or recent therapeutic antibiotics (antibiotic-free window \<14 days and past antibiotic prescription \>4 days) * Surgery for open fractures and wounds; including 2nd and 3rd looks * Potentially contaminated wound revision in the operating theatre * Tumor (oncologic) surgery (if prior radiotherapy and/or bone involvement) * Spine surgery with ASA-Score \>= 3 points, sacral involvement, or re-vision surgery * Known skin colonization with multidrug-resistant Gram-negative bacteria Exclusion Criteria: * Inability to understand the study procedure for linguistic or cognitive rea-sons * Surgery without intraoperative microbiological samples * Allergy or major intolerance to vancomycin and/or gentamicin * Anticipated clinical follow-up of less than 6 weeks after inclusion * Pregnant or breastfeeding women * Known carriage of multiresistant Gram-negative bacteria in the urine or anal region
References
Publications (5)
- BACKGROUNDUckay I, Hoffmeyer P, Lew D, Pittet D. Prevention of surgical site infections in orthopaedic surgery and bone trauma: state-of-the-art update. J Hosp Infect. 2013 May;84(1):5-12. doi: 10.1016/j.jhin.2012.12.014. Epub 2013 Feb 14. PMID 23414705
- BACKGROUNDWuarin L, Abbas M, Harbarth S, Waibel F, Holy D, Burkhard J, Uckay I. Changing perioperative prophylaxis during antibiotic therapy and iterative debridement for orthopedic infections? PLoS One. 2019 Dec 18;14(12):e0226674. doi: 10.1371/journal.pone.0226674. eCollection 2019. PMID 31851708
- BACKGROUNDJamei O, Gjoni S, Zenelaj B, Kressmann B, Belaieff W, Hannouche D, Uckay I. Which Orthopaedic Patients Are Infected with Gram-negative Non-fermenting Rods? J Bone Jt Infect. 2017 Jan 15;2(2):73-76. doi: 10.7150/jbji.17171. eCollection 2017. PMID 28529866
- BACKGROUNDMuller D, Kaiser D, Sairanen K, Studhalter T, Uckay I. Antimicrobial Prophylaxis for the Prevention of Surgical Site Infections in Orthopaedic Oncology - A Narrative Review of Current Concepts. J Bone Jt Infect. 2019 Oct 15;4(6):254-263. doi: 10.7150/jbji.39050. eCollection 2019. PMID 31966954
- DERIVEDUckay I, Bomberg H, Risch M, Muller D, Betz M, Farshad M. Broad-spectrum antibiotic prophylaxis in tumor and infected orthopedic surgery-the prospective-randomized, microbiologist-blinded, stratified, superiority trials: BAPTIST Trials. Trials. 2024 Jan 19;25(1):69. doi: 10.1186/s13063-023-07605-5. PMID 38243311