Clinical Trial: The Influence of Antibiotic Prophylaxis on Intraoperative Prosthetic Joint Infection Cultures
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: The Influence of Antibiotic Prophylaxis on Intraoperative Prosthetic Joint Infection Cultures
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
Detailed Summary:
AIM AND RATIONALE:
Hypothesis:
H0: Preoperative antibiotic prophylaxis in patients with PJI interferes with the isolation of the microorganism from the intraoperative cultures and sonication samples, resulting in higher false-negative results.
H1: Preoperative antibiotic prophylaxis in patients with PJI does not interfere with the isolation of the microorganism from the intraoperative cultures and sonication samples.
Goals:
Main Goal:
- Determine preoperative antibiotic prophylaxis outcome on cultures obtained intraoperatively.
Secondary Goals:
- Ascertain if organisms isolated from preoperative joint aspirate correspond to those isolated from intraoperative cultures;
- Verify if the addition of substances with chelation properties to hemoculture containers filled with sonication samples affects antibiotic prophylaxis outcome;
- Make a descriptive analysis and revision of microorganisms implicated in PJIs.
PATIENTS AND METHODS:
Prospective, Randomized, Double-blind Clinical trial (Level I of Evidence):
Group I (study group): antibiotic prophylaxis + empiric antibiotic treatment once obtained intraoperative culture results.
Group II (control group): Empiric antibiotic treatment once obtained intraoperative culture results.
Sponsor: Parc de Salut MarCurrent Primary Outcome:
- Positive Cultures [ Time Frame: 14 days ]Number of positive Tissue Cultures (7)
- Sonication Cultures [ Time Frame: 14 days ]Number of positive Sonication cultures (7)
Original Primary Outcome:
- Number of positive Tissue Cultures [ Time Frame: 14 days ]
- Number of positive Sonication cultures [ Time Frame: 14 days ]
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Parc de Salut Mar
Dates:
Date Received: March 24, 2015
Date Started: November 2013
Date Completion:
Last Updated: June 22, 2016
Last Verified: June 2016
