Broad-spectrum Antibiotic Prophylaxis in Tumor and Infected Orthopedic Surgery

NCT05502380 | Recruiting Phase 3 DMC

• 1 other identifier: BASEC 2022-00800
• Study Type: interventional
• Target: 1,100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Surgical Site Infection; Microbial Colonization; Antibiotic Resistant Infection

Keywords

Perioperative antibiotic prophylaxis; Selection; High Risk patients; Ranndomized-Controlled Trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

  6 weeks postoperatively, or 1 year postoperatively in case of implant-related orthopedic surgery

• Incidence of revision surgery for non-infections reasons within 6 weeks

  6 weeks postoperatively

• Proportion of the change of antibiotic therapy based on intraoperative findings

  6 weeks postoperatively

• Incidence of dverse events and global costs of therapeutic antibiotics (if any)

  6 weeks postoperatively, or 1 year postoperatively in case of implant-related orthopedic surgery

• Incidence of non-SSI infections within 6 weeks (e.g. urine infections)

  6 weeks postoperatively

Study Arms (2)

Standard prophylaxis arm

ACTIVE COMPARATOR

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

Drug: Standard antibiotic prophylaxis

Innovative prophylaxis arm

EXPERIMENTAL

Additional single-shot perioperative antibiotic prophylaxis with Broad-spectrum prophylaxis: vancomycin 1 g \& gentamicin 5 mg/kg.

Drug: Standard antibiotic prophylaxis

Interventions

Standard antibiotic prophylaxis DRUG

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; Standard prophylaxis arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Pregnant or breastfeeding women
• Known carriage of multiresistant Gram-negative bacteria in the urine or anal region

Sponsors & Collaborators

• Balgrist University Hospital: lead

Study Sites (1)

Balgrist University Hospital

Zurich, 8008, Switzerland

RECRUITING

Related Publications (5)

• 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.

  PMID: 23414705 BACKGROUND

• 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.

  PMID: 31851708 BACKGROUND

• 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.

  PMID: 28529866 BACKGROUND

• 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.

  PMID: 31966954 BACKGROUND

• 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.

  PMID: 38243311 DERIVED

MeSH Terms

Conditions

Surgical Wound Infection; Communicable Diseases

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Study Officials

• Ilker Uçkay, Professor

  Balgrist University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ilker Uçkay, Professor

CONTACT

++41 44 386 37 05; ilker.uckay@balgrist.ch

Mazda Farshad, Professor

CONTACT

++ 41 44 386 30 00; mazda.farshad@balgrist.ch

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: The microbiologists culturing the pathogens of eventual surgical site infections are blinded to the prior prophylaxis during the index surgery
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: At enrollment (Day 1), the investigator will prescribe the preoperative antibiotic prophylaxis based on instructions provided in the protocol according to the patient's randomization. Patients will be randomized in the ratio 1:1 into the investigational group (broad-spectrum prophylaxis) and the control group (usual prophylaxis). Each patient can be included several times with one episode for each surgical interven-tion in the operating theatre. The initial consent form is valid during 1 month and will be renewed in case of another inclusion following a delay of 1 month after the initial signature of the patient.

Study Record Dates

• First Submitted: August 11, 2022
• First Posted: August 16, 2022
• Study Start: September 15, 2022
• Primary Completion: December 12, 2024
• Study Completion: December 12, 2025
• Last Updated: December 2, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: 2025
• Access Criteria: The ivestigators might bilaterally share anonomyzed key elements (data) upon scientific request to the corresponding person

Locations

CH (1)