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Biofilm Formation in Staphylococcus Epidermidis Associated Implant Infections

NCT02640937 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 124

Last updated 2015-12-29

No results posted yet for this study

Summary

This was a prospective study performed between November 2011 and September 2013. Patients with a confirmed S. epidermidis infection after fracture fixation or prosthetic joint infection were included. Exclusion criteria included infections involving external fixation pins, infections without any implanted hardware and culture positive patients not displaying any clinical sign of infection. The following surgical parameters were documented: affected bone or joint; type of implant; time between implantation of the device and onset of symptoms. Personal characteristics and patients'health status were also documented. Any revision surgeries involving the site of interest and all isolated pathogens were recorded throughout the course of treatment and follow-up.

A follow up examination was performed an average of 26 months after discharge. Primary outcome at follow up was cure. Cure was define by the authors as: missing local (at site of interest) or systemic signs of infection, terminated surgical and systemic therapy and restoration of joint or limb function.

At the first surgical procedure after enrolment, at least four deep bone biopsies were taken from the interface between implant and affected bone. Identification and antibiotic susceptibility testing of all growth was performed. Multi-drug-resistance (MDR) was defined according to the definitions of the European Committee of Antimicrobial Susceptibility Testing (EUCAST). Biofilm formation was analysed and quantified in microtitre plate assays according to protocol of Stepanovic et al.(see references).

Conditions

  • Staphylococcal Infections

Sponsors & Collaborators

  • BG Unfallklinik Murnau

    lead OTHER

Principal Investigators

  • Mario Morgenstern, M.D. · BGUnfallklinik Murnau

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2015-09-30
Completion
2015-11-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02640937 on ClinicalTrials.gov