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New treatment option for Surgical Site Infection
Official title Broad-spectrum Antibiotic Prophylaxis in Tumor and Infected Orthopedic Surgery
ClinicalTrials.gov ID: NCT05502380
What this study is testing
What is Standard antibiotic prophylaxis?
Standard antibiotic prophylaxis is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for surgical site infection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18 years
- Surgery under current or recent therapeutic antibiotics (antibiotic-free window \ 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)
You likely can't join 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
- 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
See the full eligibility criteria
- Age ≥ 18 years
- Surgery under current or recent therapeutic antibiotics (antibiotic-free window \ 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Zurich, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Zurich, Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.