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Effect of Prophylactic Antibiotics on Intra-Operative Culture Results

Effect of Prophylactic Antibiotics on Intra-Operative Culture Results

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01174212
Enrollment
65
Registered
2010-08-03
Start date
2010-07-31
Completion date
2012-07-31
Last updated
2012-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infection, Arthroplasty

Keywords

revision, infection, knee, hip, replacement, antibiotics

Brief summary

Subjects will be consented and then determined randomly whether they will receive antibiotics prior to their surgery or during their surgery. Each patient will have cultures taken before and during their surgery from the infected hip or knee. Results will be compared after completion of the study.

Detailed description

It is unknown whether giving pre-operative antibiotics affects the results of intraoperative bacterial cultures. This is an important question as antibiotics are often not given prior to surgery out of concern that accurate culture results will not be obtained. It is important to obtain accurate cultures so that targeted antibiotic therapy can be used. However, delaying the administration of antibiotics also delays the onset of treatment. Currently, the optimal course of action is unknown. The purpose of this study is to resolve this issue and determine if prophylactic antibiotics affect intra-operative culture results in patients undergoing revision hip or knee arthroplasty surgery for infection. This is a prospective randomized clinical study to determine if prophylactic antibiotics affect intra-operative culture results in patients undergoing revision hip or knee arthroplasty surgery for infection. Pre-operatively, patients will have their affected joint aspirated and this fluid will be sent for cultures. Patients are then randomized to receive prophylactic antibiotics (Vancomycin and Ancef) within one hour prior to surgery or to have pre-operative antibiotics withheld. Every patient then has their affected joint cultured intra-operatively. All samples will be evaluated for the presence of aerobic bacteria, anaerobic bacteria, mycobacteria, and fungus. Pre-operative and post-operative cultures in both study populations are compared to determine the effects of pre-operative antibiotics.

Interventions

Preoperative Antibiotics

PROCEDUREControl Antibiotics

Antibiotics will be held until intraoperative cultures have been obtained.

Sponsors

Rothman Institute Orthopaedics
CollaboratorOTHER
Rush University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* prior arthroplasty surgery of the hip or knee * presentation to clinic with infected joint * scheduled for revision surgery

Exclusion criteria

* patients who have received antibiotics for any reason within 4 weeks of their pre-operative culture * infected native joints * septic patients * refusal of participation

Design outcomes

Primary

MeasureTime frameDescription
Changes in cultures obtained preoperatively and intraoperatively1 yearPatients suspected of having an infected total hip or knee replacement in the post-operative period will be evaluated clinically. Preoperative and intraoperative revision cultures will be compared.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026