Broad-spectrum Antibiotic Prophylaxis in Tumor and Infected Orthopedic Surgery
NCT ID: NCT05502380
Last Updated: 2024-12-02
Study Results
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Basic Information
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RECRUITING
PHASE3
1100 participants
INTERVENTIONAL
2022-09-15
2025-12-12
Brief Summary
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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.
Detailed Description
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Additionally, orthopedic surgeons operating selected patient populations (neoplasms, open fractures, postoperative wound dehiscence9, diabetic foot infections or already infected body sites) experience a high risk of prophylactic-resistant pathogens, or pathogens resistant to current therapeutic antibiotics regimens. At least 10% of all new intraoperative tissue samples, during iterative surgical debridement, yield (new) pathogens unknown to the clinicians.
This is due to selection by prophylactic or therapeutic antibiotics, which only kill the previously detected pathogens, but left over newly introduced contaminants, remnant parts of partially-diagnosed polymicrobial infections; ultimately leading to a new SSIs occurring during therapy for the first infection at the orthopedic site. This selection is unpredictable involving both Gram-positive skin pathogens as well as (multi) resistant Gram-negative rods.From a microbiological point of view, only a maximal Gram-negative coverage, alongside with a large Gram-negative coverage, would cover these selections.
The literature is in-existing how to prevent these selections. Most clinicians just continue with the standard prophylactic recommendation, or the current thera-peutic antibiotic regimen. Theoretically, clinicians cannot exclude that these selected patient populations eventually might profit from a broad-spectrum prophylaxis.
The BAPTIST trials only concern the perioperative antibiotic prophylaxis in selected situations of orthopedic surgery: tumor surgery, debridement for postoperative dehiscent wounds, debridement under antibiotics, open fractures, skin colonization with multidrug-resistant bacteria, plus, as a control; spine surgery in selected multimorbid patients. The investigators alternately randomize the standard prophylaxis (or by continuing the current antibiotic treatment) to the additional broad-spectrum single-shot of vancomycin 1g IV \& single-shot of gentamicin 5 mg/kg intravenously; before an eventual intraoperative sampling. End-of-Treatment (EOT) and/or Test-of-Cure (TOC) occur latest at the 6-week's surgical control visit. The rest of the hospital stay, treatment, the use of negative-pressure vacuum therapy, other interventions, local antibiotic therapies; therapies or procedure are at the discretion of the treating clinicians.
The investogators will randomize surgical interventions defined by the inclusion criteria in a prospective-alternating scheme (1:1) according to the scheduled position in the operating theatres. The anesthetists (or the nurses at the hospitalization units) the will administer the standard prophylaxis (or the therapeutic antibiotics) alone, or with the addition of the single-shot broad-spectrum prophylaxis regimen composed of vancomycin and gentamicin. In case of clinical suspicion of infection or massive contamination, the surgeons will perform at least three microbiological intraoperative tissue samples. Each surgery counts as an independent event. If a patient is debrided several times, he/she can have different prophylaxis regimens during each of the interventions. After the prophylactic regimen, the clinicians are free to continue with a targeted or empirical therapeutic antibiotic regimen. The antibiotic therapy per se is not an objective of this current trials.
The treatment period includes the following daily study visits:
* Visit 1 - Enrollment (Day 1)
* EOT (end of microbiological cultures) - Day 14 (+/- 3 days)
* TOC (clinical surgical control) - Day 42 (+/- 14 days)
* Follow-up (telephone) for implant-related surgery - 1 year (+/- 2 months)
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Standard prophylaxis arm
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
Standard antibiotic prophylaxis
One to three intravenous doses of cefuroxime 1.5 g intravenously; or 3g if obesity; or vancomycin 1 g or clindamycin 600 mg; if allergy. Continuation of eventual current therapeutic antibiotc regimens for any infection
Innovative prophylaxis arm
Additional single-shot perioperative antibiotic prophylaxis with Broad-spectrum prophylaxis: vancomycin 1 g \& gentamicin 5 mg/kg.
Standard antibiotic prophylaxis
One to three intravenous doses of cefuroxime 1.5 g intravenously; or 3g if obesity; or vancomycin 1 g or clindamycin 600 mg; if allergy. Continuation of eventual current therapeutic antibiotc regimens for any infection
Interventions
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Standard antibiotic prophylaxis
One to three intravenous doses of cefuroxime 1.5 g intravenously; or 3g if obesity; or vancomycin 1 g or clindamycin 600 mg; if allergy. Continuation of eventual current therapeutic antibiotc regimens for any infection
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Balgrist University Hospital
OTHER
Responsible Party
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Principal Investigators
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Ilker Uçkay, Professor
Role: PRINCIPAL_INVESTIGATOR
Balgrist University Hospital
Locations
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Balgrist University Hospital
Zurich, , Switzerland
Countries
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Central Contacts
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References
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Uckay 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.
Wuarin 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.
Jamei 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.
Muller 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.
Uckay 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.
Other Identifiers
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BASEC 2022-00800
Identifier Type: -
Identifier Source: org_study_id