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Trial Title:
Broad-spectrum Antibiotic Prophylaxis in Tumor and Infected Orthopedic Surgery
NCT ID:
NCT05502380
Condition:
Surgical Site Infection
Microbial Colonization
Antibiotic Resistant Infection
Conditions: Official terms:
Infections
Communicable Diseases
Surgical Wound Infection
Anti-Bacterial Agents
Conditions: Keywords:
Perioperative antibiotic prophylaxis
Selection
High Risk patients
Ranndomized-Controlled Trial
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
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.
Primary purpose:
Prevention
Masking:
Single (Care Provider)
Masking description:
The microbiologists culturing the pathogens of eventual surgical site infections are
blinded to the prior prophylaxis during the index surgery
Intervention:
Intervention type:
Drug
Intervention name:
Standard antibiotic prophylaxis
Description:
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
Arm group label:
Innovative prophylaxis arm
Arm group label:
Standard prophylaxis arm
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.
Detailed description:
The perioperative antibiotic prophylaxis is evidence-based for the majority of orthopedic
surgeries. While the debate of its duration and timing (single-dose versus triple-dose;
before or after the intraoperative microbiological sampling) may continue, no clinicians
doubt on the efficiency of the recommended prophylactic agents; that are mostly 1st or
2nd-generation cephalosporins, co-amoxiclav or other exceptional agents in cases of
(pseudo)-allergy. However. and traditionally, up to the half of all detected pathogens of
orthopedic SSI's are not covered by the prior prophylactic regimens: e.g. SSIs due to
methicillin-resistant cocci or non-fermenting Gram-negative rods in orthopedic surgery.
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)
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Balgrist University Hospital
Address:
City:
Zurich
Zip:
8008
Country:
Switzerland
Status:
Recruiting
Start date:
September 15, 2022
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Balgrist University Hospital
Agency class:
Other
Source:
Balgrist University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05502380