MICRO Study: Detecting Bacterial Infections Related to Orthopaedic Surgical Implants

NCT ID: NCT03132246

Last Updated: 2020-05-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 260 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2018-07-31

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.

Detailed Description

Surgical site infection in the orthopaedic surgery population is a significant public health issue. Wound infections result in both increased length of hospital stay and total cost of care.

Surgical site infection (SSI) is the most common preventable adverse outcome after a major operation. The economic costs to the US healthcare system are enormous estimated to be in excess of $1.8 billion per year. For patients who develop an SSI, the cost may be even higher with length of stay and risk of death doubled. Thus the benefits of any intervention decreasing the risk of SSI are very tangible.

A biofilm is a layer of bacteria that adheres to a surface; in Orthopaedics, this often means adherence to implanted metal after fracture surgery. The test that has been designed by one of the investigators on the study has been shown in an animal model to detect the formation of a biofilm up to 1 month prior to clinical detection. Having a blood assay such as this would allow earlier antibiotics and potentially prevent the need for further surgeries to remove metal implants and clean out the biofilm.

Conditions

Open Reduction and Internal Fixation of Extremity Fractures

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Blood draws

Intervention Type: DIAGNOSTIC_TEST

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

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.

Blood draws

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Blood draws

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Maryland, Baltimore

OTHER

Sponsor Role: lead

Responsible Party

Robert O'Toole

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert V O'Toole, MD

Role: PRINCIPAL_INVESTIGATOR

University of Maryland, College Park

Mark Shirtliff, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Maryland, College Park

Locations

University of Maryland, Shock Trauma Center

Baltimore, Maryland, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 21282411 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

HP-00055743

Identifier Type: -

Identifier Source: org_study_id