Biofilm Formation in Staphylococcus Epidermidis Associated Implant Infections

NCT02640937 | Completed

• 1 other identifier: 12063
• Study Type: observational
• Target: 124
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Staphylococcus epidermidis; biofilm formation; antibiotic resistance; Orthopaedic device related infections; risk factor

Outcome Measures

Primary Outcomes (1)

• Cure

  Cure was define by the authors as: missing local (at site of interest) or systemic signs of infection and terminated surgical and systemic antibiotic therapy. All Parameters had to be positive to fulfill the outcome parameter "cure".If one of the mentioned parameters was negative, outcome was defined as "not cured". Local signs of infection were defined as the appearance of: redness, tenderness, swelling or persisting wound drainage.

  24 month

Study Arms (1)

Orthopaedic device related infections

Inclusion Criteria: * infections after fracture fixation or prosthetic joint surgery * Affected bone or joint: Long bones of the lower extremity; hip joint, knee joint; * Bacterial growth of S. epidermidis at the site of interest * Written consent * Age: 18 and older

Eligibility Criteria

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

Study Population

Orthopaedic device related infection involving longbones of the lower extermity

You may qualify if:

• infections after fracture fixation or prosthetic joint surgery
• Affected bone or joint: Long bones of the lower extremity; hip joint, knee joint;
• Bacterial growth of S. epidermidis at the site of interest
• Written consent
• Age: 18 and older

You may not qualify if:

• no prove of bacterial growth at site of interest
• missing consent
• infections involving external fixation pins, infections without any implanted hardware.

Sponsors & Collaborators

• BG Unfallklinik Murnau: lead

Study Sites (1)

BG Unfallklinik Murnau

Murnau am Staffelsee, Bavaria, 82418, Germany

Location

Related Publications (2)

• Stepanovic S, Vukovic D, Hola V, Di Bonaventura G, Djukic S, Cirkovic I, Ruzicka F. Quantification of biofilm in microtiter plates: overview of testing conditions and practical recommendations for assessment of biofilm production by staphylococci. APMIS. 2007 Aug;115(8):891-9. doi: 10.1111/j.1600-0463.2007.apm_630.x.

  PMID: 17696944 BACKGROUND

• Post V, Harris LG, Morgenstern M, Mageiros L, Hitchings MD, Meric G, Pascoe B, Sheppard SK, Richards RG, Moriarty TF. Comparative Genomics Study of Staphylococcus epidermidis Isolates from Orthopedic-Device-Related Infections Correlated with Patient Outcome. J Clin Microbiol. 2017 Oct;55(10):3089-3103. doi: 10.1128/JCM.00881-17. Epub 2017 Aug 9.

  PMID: 28794175 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Bacterial samples from orthopaedic device realted infections

MeSH Terms

Conditions

Staphylococcal Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Mario Morgenstern, M.D.

  BGUnfallklinik Murnau

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist in Orthopedic Surgery

Study Record Dates

• First Submitted: December 16, 2015
• First Posted: December 29, 2015
• Study Start: November 1, 2011
• Primary Completion: September 1, 2015
• Study Completion: November 1, 2015
• Last Updated: December 29, 2015

Record last verified: 2015-12

Locations

DE (1)