MICRO Study: Detecting Bacterial Infections Related to Orthopaedic Surgical Implants

NCT03132246 | Completed Results DMC

• 1 other identifier: HP-00055743
• Study Type: observational
• Target: 260
• Locations: 1 country
• Sites: 1

Brief Summary

A prospective trial conducted at Shock Trauma of patients between 18 years of age and older who have sustained a fracture with metal implanted. The investigators will be collecting between 1-3 routine blood draws for the purpose of laboratory analysis to assess biofilm growth. Patients may be infected or non-infected at the time of blood draw; they will be selected at random for purposes of this study. All patients will be followed as standard of care by their treating physician for all their follow up visits.

Conditions

Open Reduction and Internal Fixation of Extremity Fractures

Keywords

Methicillin-resistant Staphylococcus aureus (MRSA); Infection; Biofilm Assay

Outcome Measures

Primary Outcomes (1)

• Number of Blood Samples With High Levels of Absorbance Via ELISA for Patients (Greater Than 1.5 Ratio Compared to Control Human Serum)

  A high level of absorbance via ELISA (greater than 1.5 ratio compared to control human serum) is a positive test result. The rate of not infected patient samples that return positive will demonstrate the false positive rate of the test.

  1 year of clinical follow-up

Secondary Outcomes (1)

• Number of Blood Samples With Low Levels of Absorbance Via ELISA for Patients (Greater Than 1.5 Ratio Compared to Control Human Serum)

  1 year of clinical follow-up

Study Arms (2)

Infected

Trauma patients that were considered at risk for infection after fracture fixation. Inclusion criteria included open fractures, proximal tibia fractures, pilon fractures, and calcaneus fractures treated with surgical fixation. Each patient enrolled in the study provided 1-3 blood samples. These blood samples were tested using basic science techniques to determine the level of exposure to a staphylococcal biofilm each patient has experienced over a period of time. The only intervention patients experience are non-standard of care blood draws. The blood is then tested in a basic science laboratory. Patients were enrolled if presented as high risk but later separated into the Infected Group or the Not Infected Group based on whether or not they went on to develop an infection post surgery. All patients in this group went on to develop an infection.

Diagnostic Test: Blood draws

Not Infected

Trauma patients that were considered at risk for infection after fracture fixation. Inclusion criteria included open fractures, proximal tibia fractures, pilon fractures, and calcaneus fractures treated with surgical fixation. Each patient enrolled in the study provided 1-3 blood samples. These blood samples were tested using basic science techniques to determine the level of exposure to a staphylococcal biofilm each patient has experienced over a period of time. The only intervention patients experience are non-standard of care blood draws. The blood is then tested in a basic science laboratory. Patients were enrolled if presented as high risk but later separated into the Infected Group or the Not Infected Group based on whether or not they went on to develop an infection post surgery. All patients in this group did not go on to develop an infection.

Diagnostic Test: Blood draws

Interventions

Blood draws DIAGNOSTIC_TEST

The only intervention patients experience are non-standard of care blood draws. The blood is then tested in a basic science laboratory.

Infected; Not Infected

Eligibility Criteria

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

Study Population

Trauma patients that were considered at risk for infection after fracture fixation. Inclusion criteria included open fractures, proximal tibia fractures, pilon fractures, and calcaneus fractures treated with surgical fixation.

You may qualify if:

• Previous fracture fixation with an implant (intramedullary nail, plate, screws), or joint revisions, or periprosthetic fracture, or admitted from orthopaedic trauma clinic due to infection, or inpatient with a known infection.
• English speaking

You may not qualify if:

• Patients with planned follow-up at another medical center
• Patient lives outside of the hospital catchment area

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland, Shock Trauma Center

Baltimore, Maryland, 21201, United States

Location

Related Publications (1)

• Prabhakara R, Harro JM, Leid JG, Harris M, Shirtliff ME. Murine immune response to a chronic Staphylococcus aureus biofilm infection. Infect Immun. 2011 Apr;79(4):1789-96. doi: 10.1128/IAI.01386-10. Epub 2011 Jan 31.

  PMID: 21282411 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

The only intervention patients experience are non-standard of care blood draws. The blood is then tested in a basic science laboratory.

MeSH Terms

Conditions

Infections

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: Dr. Aaron Johnson
• Organization: University of Maryland School of Medicine

ajohnson1@som.umaryland.edu

410-328-1868

Study Officials

• Robert V O'Toole, MD

  University of Maryland, College Park

  PRINCIPAL INVESTIGATOR

• Mark Shirtliff, PhD

  University of Maryland, College Park

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the UM SOM's Division of Orthopaedic Traumatology and Chief of Orthopaedic Traumatology and CHief of Orthopaedics for the University of Maryland Medical Center's (UMMS) R Adams Cowley Shock Trauma Center

Study Record Dates

• First Submitted: April 7, 2017
• First Posted: April 27, 2017
• Study Start: April 1, 2014
• Primary Completion: June 30, 2018
• Study Completion: July 31, 2018
• Last Updated: May 15, 2020
• Results First Posted: May 15, 2020

Record last verified: 2020-05

Locations

US (1)