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Trial record 7 of 50 for:    "Prosthetic Joint Infection"

The Influence of Antibiotic Prophylaxis on Intraoperative Prosthetic Joint Infection Cultures

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ClinicalTrials.gov Identifier: NCT02413034
Recruitment Status : Completed
First Posted : April 9, 2015
Results First Posted : August 3, 2016
Last Update Posted : August 3, 2016
Sponsor:
Information provided by (Responsible Party):
Daniel Pérez Prieto, Parc de Salut Mar

Brief 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.


Condition or disease Intervention/treatment Phase
Prosthetic Joint Infection Drug: Cefazolin Other: Control group Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Influence of Antibiotic Prophylaxis on Intraoperative Prosthetic Joint Infection Cultures
Study Start Date : November 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
Placebo Comparator: Control group
no antibiotic prophylaxis group
Other: Control group
no antibiotic prophylaxis

Active Comparator: Study group cefazolin
Classical antibiotic prophylaxis
Drug: Cefazolin
Cefazolin (vancomycin in the case of allergy to cefazolin)
Other Name: vancomycin




Primary Outcome Measures :
  1. Positive Cultures [ Time Frame: 14 days ]
    Number of positive Tissue Cultures (7)

  2. Sonication Cultures [ Time Frame: 14 days ]
    Number of positive Sonication cultures (7)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: as defined previously

  • All the patients diagnosed with PJI who meet Zimmerli criteria and undergo a first-stage exchange, or débridment and retention procedure, in case there is an acute infection. These criteria are: visible sinus tract or purulence surrounding the prosthesis; detection of an infecting microorganism in the synovial fluid aspiration samples, intraoperative tissue and/or fluid cultures; synovial white blood cell count and histopathology parameters. The investigators will also include an additional criterion, which is prosthetic loosening 2 years after primary arthroplasty implantation following recent Portillo findings.
  • The investigators will include hip, knee and shoulder replacements.

Exclusion Criteria:

  • Patients receiving any kind of antibiotic regimen during the previous week of surgery;
  • Hemodynamically unstable patients in need of antibiotic therapy, previously to the surgery.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02413034


Sponsors and Collaborators
Parc de Salut Mar
Investigators
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Study Director: Daniel Pérez-Prieto, MD Hospital del Mar

Publications:
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Responsible Party: Daniel Pérez Prieto, MD, Parc de Salut Mar
ClinicalTrials.gov Identifier: NCT02413034     History of Changes
Other Study ID Numbers: 2014/5533/I
First Posted: April 9, 2015    Key Record Dates
Results First Posted: August 3, 2016
Last Update Posted: August 3, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Daniel Pérez Prieto, Parc de Salut Mar:
antibiotic
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Arthritis, Infectious
Arthritis
Joint Diseases
Musculoskeletal Diseases
Anti-Bacterial Agents
Vancomycin
Cefazolin
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents