The Influence of Antibiotic Prophylaxis on Intraoperative Prosthetic Joint Infection Cultures

NCT02413034 | Completed Results DMC

• 1 other identifier: 2014/5533/I
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Prosthetic Joint Infection

Keywords

antibiotic

Outcome Measures

Primary Outcomes (2)

• Positive Cultures

  Number of positive Tissue Cultures (7)

  14 days

• Sonication Cultures

  Number of positive Sonication cultures (7)

  14 days

Study Arms (2)

Control group

PLACEBO COMPARATOR

no antibiotic prophylaxis group

Other: Control group

Study group cefazolin

ACTIVE COMPARATOR

Classical antibiotic prophylaxis

Drug: Cefazolin

Interventions

Cefazolin DRUG

Cefazolin (vancomycin in the case of allergy to cefazolin)

Also known as: vancomycin

Study group cefazolin

Control group OTHER

no antibiotic prophylaxis

Control group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Parc de Salut Mar: lead

Related Publications (4)

• Zimmerli W, Trampuz A, Ochsner PE. Prosthetic-joint infections. N Engl J Med. 2004 Oct 14;351(16):1645-54. doi: 10.1056/NEJMra040181. No abstract available.

  PMID: 15483283 BACKGROUND

• Trampuz A, Piper KE, Jacobson MJ, Hanssen AD, Unni KK, Osmon DR, Mandrekar JN, Cockerill FR, Steckelberg JM, Greenleaf JF, Patel R. Sonication of removed hip and knee prostheses for diagnosis of infection. N Engl J Med. 2007 Aug 16;357(7):654-63. doi: 10.1056/NEJMoa061588.

  PMID: 17699815 BACKGROUND

• Burnett RS, Aggarwal A, Givens SA, McClure JT, Morgan PM, Barrack RL. Prophylactic antibiotics do not affect cultures in the treatment of an infected TKA: a prospective trial. Clin Orthop Relat Res. 2010 Jan;468(1):127-34. doi: 10.1007/s11999-009-1014-4. Epub 2009 Aug 11.

  PMID: 19669849 BACKGROUND

• Portillo ME, Salvado M, Alier A, Sorli L, Martinez S, Horcajada JP, Puig L. Prosthesis failure within 2 years of implantation is highly predictive of infection. Clin Orthop Relat Res. 2013 Nov;471(11):3672-8. doi: 10.1007/s11999-013-3200-7. Epub 2013 Aug 1.

  PMID: 23904245 BACKGROUND

MeSH Terms

Interventions

Cefazolin; Vancomycin; Control Groups

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Results Point of Contact

• Title: Daniel Pérez-Prieto
• Organization: Hospital del Mar

dperezprieto@hospitaldelmar.cat

0034932483196

Study Officials

• Daniel Pérez-Prieto, MD

  Hospital del Mar

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 24, 2015
• First Posted: April 9, 2015
• Study Start: November 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: January 1, 2015
• Last Updated: August 3, 2016
• Results First Posted: August 3, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share