Surgical Site Infection Clinical Trial
— BAPTISTOfficial title:
Broad-spectrum Antibiotic Prophylaxis in Tumor and Infected Orthopedic Sur-gery - the Prospective-randomized, Microbiologist-blinded, Stratified, Superiority Trials - BAPTIST Trials
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.
Status | Recruiting |
Enrollment | 414 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | Balgrist University Hospital | Zurich |
Lead Sponsor | Collaborator |
---|---|
Balgrist University Hospital |
Switzerland,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of Surgical Site Infections (SSI) at 6 weeks for surgeries without implant; and 1 year for surgeries with implant | Assessment of SSI at the clinical controls according to clinical criteria in the literature (pus, discharge, pain, inflammation, several deep tissue microbiological cultures | 6 weeks postoperatively, or 1 year postoperatively in case of implant-related orthopedic surgery | |
Secondary | Proportion of antibiotic-resistant pathogens in the deep surgical site of the study patients; in relation to the prior antibiotic prophylaxis or the current therapeu-tic antibiotic therapy | Assessments of antibiotic resistance of pathogens according to standard susceptibilty testing in the Microbiological Laboratory | 6 weeks postoperatively, or 1 year postoperatively in case of implant-related orthopedic surgery | |
Secondary | Incidence of revision surgery for non-infections reasons within 6 weeks | Unplanned revision surgery in the operating theatre for any reasons | 6 weeks postoperatively | |
Secondary | Proportion of the change of antibiotic therapy based on intraoperative findings | Asssesment in the medical files. Have therapeutic antibiotics been changed according to new intraoperative bacterial culture findings | 6 weeks postoperatively | |
Secondary | Incidence of dverse events and global costs of therapeutic antibiotics (if any) | If there is therapeutic antibiotc treatment necessary, the investigators assess the drugs, the adverse events and the global costs related to the antibiotc treatment. The costs are the global (overall) hospitalizations costs in Swiss Francs. | 6 weeks postoperatively, or 1 year postoperatively in case of implant-related orthopedic surgery | |
Secondary | Incidence of non-SSI infections within 6 weeks (e.g. urine infections) | Assessment of all nosocomial and community-acquired infections ocrruging in the immediate postoperative period and relate them to prior perioperative antibiotic prophylaxis | 6 weeks postoperatively | |
Secondary | Incidence of skin and body colonization with Gram-negative multi-resistant bacteriaweeks (if there are any samples) | Assessment of the impact of the priorantibiotic prophylaxis on the body colonization with multiresistant bacteria of concern for infection control | 4-6 weeks postoperatively |
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