The Influence of Antibiotic Prophylaxis on Intraoperative Prosthetic Joint Infection Cultures
NCT02413034 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28
Last updated 2016-08-03
Summary
Total joint replacement is a common clinical practice for patients suffering from disabling arthritis, since it provides significant pain relief and functional recovering. Nevertheless, its outcome is compromised by complications such as periprosthetic joint infection (PJI), which is reported to occur in 1 to 4% of primary total knee arthroplasties (TKA), and approximately 1% of primary total hip replacements (THR). Despite all efforts to restrain PJI, its prevalence may reach even higher proportions if patients undergo a resection arthroplasty or irrigation and débridement for infected prosthesis. That said, timely diagnosis and early isolation of the infected microorganism is utterly important, if proper care is to be delivered.
The gold standard for the diagnosis of PJI is the isolation of a microorganism from the intraoperative cultures, combined with the sonication from retrieved joint implants1. This technique applies sound energy to agitate and disrupt biofilm, dislodging adherent bacterias to the bone cement, which has been proved to be a more sensitive method than conventional intraoperative cultures. False-negative percentages were reported to be 15% in patients who did not receive extended antibiotic prophylaxis and 60% if extended antibiotic therapy was administered.
Regardless of an adequate clinical, radiographic and surgical suspicion confirming PJI, an organism is not always successfully isolated from the intraoperative cultures, which increases false negatives results. This fact has been trying to be explained by several authors, some of which postulate that antibiotic prophylaxis could interfere with the isolation of the microorganism from the intraoperative cultures. As a result, and acting accordingly to this hypothesis, preoperative antibiotics are often withheld until intraoperative cultures are obtained, hoping that tissues are not loaded with antibiotics. Nevertheless, one should be aware of the adverse consequences of this practice that may result in systemic dissemination of infection.
Moreover, Ghanem and Stephen recently concluded that antibiotic prophylaxis does not interfere with the isolation of the microorganism from intraoperative cultures, despite being studies that lack statistical power.
Therefore, it is clear that reported studies in this field support both preoperative antibiotic prophylaxis administration, as well its withdrawal, until intraoperative cultures are obtained.
This decision in the department study depends exclusively on the treating surgeon judgment. In fact, 48% of all patients admitted at the study hospital with PJI receive preoperative antibiotic prophylaxis, which could be related to higher false-negative intraoperative culture and sonication results. Thus, the investigators add substances with chelation properties to hemoculture containers and then inoculate sonication samples. This practice offsets antibiotic interference with intraoperative cultures and has proved to enhance microorganism detection rates.
That said, and given the lack of scientific evidence about this clinical practice the investigators are willing to engage a prospective randomized double-blind clinical trial, that will allow us to determine whether intraoperative cultures and sonication samples are affected by antibiotic prophylaxis.
Conditions
- Prosthetic Joint Infection
Interventions
- DRUG
-
Cefazolin
Cefazolin (vancomycin in the case of allergy to cefazolin)
- OTHER
-
Control group
no antibiotic prophylaxis
Sponsors & Collaborators
-
Parc de Salut Mar
lead OTHER
Principal Investigators
-
Daniel Pérez-Prieto, MD · Hospital del Mar
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-11-30
- Primary Completion
- 2014-12-31
- Completion
- 2015-01-31
More Related Trials
-
Bacteriological Setting Before Prosthesis Implantation With One Stage Surgery in Prosthetic Joint Infection
NCT02806063 ·Status: COMPLETED ·Phase: NA
-
β-lactam Use in Single-stage Exchange of ProstheTic Infections (Knee / Hip) in a Center of Reference (β-SEPTIC)
NCT04123964 ·Status: UNKNOWN
-
Quality of Life Assessment in Patients Undergoing Prolonged Suppressive Antibiotherapy for Prosthetic Joint Infection.
NCT02805803 ·Status: UNKNOWN ·Phase: NA
-
Efficacy of Local Antibiotic Injection Via a Catheter for Treating Acute Periprosthetic Infections After Knee DAIR Surgery
NCT06468163 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Knee Prosthetic Joint Infection Antibiotic Elution
NCT06023238 ·Status: WITHDRAWN
-
Incidence of Infection After Total Knee Arthroplasty Using an Erythromycin and Colistin Loaded Cement or a Standard Cement
NCT01631968 ·Status: COMPLETED ·Phase: NA
-
Evaluation of PLG0206 in Prevention of Recurrent Infection in Patients Undergoing Debridement, Antibiotics, and Implant Retention (DAIR) for Treatment of a Periprosthetic Joint Infection (PJI) Following Knee Arthroplasty
NCT07214311 ·Status: RECRUITING ·Phase: PHASE2/PHASE3
-
Effect of Prophylactic Antibiotics on Intra-Operative Culture Results
NCT01174212 ·Status: COMPLETED ·Phase: PHASE4
-
Cohort of Prosthetic Joint Infections
NCT02801253 ·Status: RECRUITING
-
Preoperative Daptomycin Prophylaxis in Two-Stage Exchange Arthroplasty: A Prospective, Randomized, Double-Blinded Trial
NCT06189885 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Identification of Molecular Marker of Coagulase-negative Staphylococci for the Diagnosis of Prosthetic Joint Infections
NCT04661345 ·Status: UNKNOWN
-
Efficacy of Dalbavancin in Osteoarticular Infections Associated With Hip and Knee Replacements
NCT05046860 ·Status: RECRUITING ·Phase: NA
-
Efficacy and Safety of Intravenous Fosfomycin in Prosthetic Joint Infection
NCT05211011 ·Status: UNKNOWN ·Phase: PHASE4
-
Microbiological Structure of Pathogens of Periprosthetic Infection of Large Joints in the Post-Covid Period
NCT06267287 ·Status: COMPLETED
-
Infection Prophylaxis in Total Joint Replacement
NCT06126614 ·Status: RECRUITING ·Phase: PHASE3
-
Can Intraosseous Antibiotics Improve the Results of Irrigation & Debridement and Prosthetic Retention for PJI?
NCT03713528 ·Status: ENROLLING_BY_INVITATION ·Phase: PHASE4
-
Use of Collatamp G Antibiotic Impregnated Sponges in the Treatment of Peri-prosthetic Total Joint Infections
NCT01667874 ·Status: TERMINATED ·Phase: PHASE3
-
Staphylococcal Acute Post-Operative PJI Treated With 'DAIR' And Impact Of Rifampin
NCT03750721 ·Status: COMPLETED
-
Oral Antibiotics After 2-Stage Revision for Infected Total Hip Arthroplasty and Total Knee Arthroplasty
NCT01760863 ·Status: COMPLETED ·Phase: NA
-
Treatment of Acute Periprosthetic Joint Infection Comparing Single and Planned Double-Debridement Antibiotics and Implant Retention Followed by Chronic Antibiotic Suppression
NCT05640336 ·Status: ENROLLING_BY_INVITATION ·Phase: NA
-
Dosing of Antibiotics During Reimplantation of Infected Knee and Hip Prostheses
NCT02860767 ·Status: COMPLETED
-
The Utility of Levofloxacin-Rifampin in the Therapy of Prosthetic Joint Infection
NCT00279864 ·Status: COMPLETED
-
Proper Duration of Suppressive Antibiotic Therapy After Debridement, Antibiotics, and Implant Retention
NCT05495815 ·Status: WITHDRAWN ·Phase: NA
-
Joint Microbiome Study for the Knee
NCT05254145 ·Status: UNKNOWN
-
One-stage Exchange Arthroplasty for Chronic Prosthetic Joint Infections
NCT03473392 ·Status: COMPLETED