Open Reduction and Internal Fixation of Extremity FracturesMICRONCT03132246

MICRO Study: Detecting Bacterial Infections Related to Orthopaedic Surgical Implants

An observational study of Open Reduction and Internal Fixation of Extremity Fractures, run by University of Maryland, Baltimore at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Open Reduction and Internal Fixation of Extremity Fractures
What is being tested?: Blood draws
How many people: 260 participants
Where: 1 siteUnited States
Study dates: Apr 2014to 31 Jul 2018
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Maryland, Shock Trauma Center
Baltimore, Maryland, 21201

Other trials in United States

About this study

Official title: Early Determination of Biofilm Formation on Orthopaedic Devices

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.

Read the 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
Being tested: Blood draws
Keywords: Methicillin-resistant Staphylococcus aureus (MRSA), Infection, Biofilm Assay
Medical subject headings: Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT03132246
Study group	Role	What they receive
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. Receives: 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. Receives: Diagnostic Test: Blood draws

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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)
A low level of absorbance via ELISA (greater than 1.5 ratio compared to control human serum) is a negative test result. The rate of infected patient samples that return negative will demonstrate the false negative rate of the test.
Measured: 1 year of clinical follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 201431 Jul 2018

First posted27 Apr 2017
Study startApr 2014
Primary completion30 Jun 2018
Study completion31 Jul 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Open Reduction and Internal Fixation of Extremity FracturesStudies of the same condition, open and under way.
More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 260 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03132246
Sponsor's protocol ID: HP-00055743
Acronym: MICRO
Status last verified: May 2020
First submitted: 7 Apr 2017
Last updated: 15 May 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 21282411

Study at a glance

From the registry record, last updated by the sponsor on 15 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Early Determination of Biofilm Formation on Orthopaedic Devices
ClinicalTrials.gov ID: NCT03132246
Acronym / sponsor ID: MICRO / HP-00055743
Conditions: Open Reduction and Internal Fixation of Extremity Fractures
Keywords: Methicillin-resistant Staphylococcus aureus (MRSA), Infection, Biofilm Assay
Study type: Observational
Recruitment status: Completed
Enrolment: 260 participants (actual)
Lead sponsor: University of Maryland, BaltimoreUniversity, hospital or other
Study start: Apr 2014
Primary completion: 30 Jun 2018 (actual)
Study completion: 31 Jul 2018 (actual)
First posted: 27 Apr 2017 (actual)
Results: Posted 15 May 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Infected	–	Diagnostic Test: Blood drawsTrauma 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.
Not Infected	–	Diagnostic Test: Blood drawsTrauma 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (2 listed)

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

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Blood drawsThe only intervention patients experience are non-standard of care blood draws. The blood is then tested in a basic science laboratory.	Diagnostic test	Infected, Not Infected

Primary outcome

Number of Blood Samples With High Levels of Absorbance Via ELISA for Patients (Greater Than 1.5 Ratio Compared to Control Human Serum)
Time frame: 1 year of clinical follow-up
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 secondary outcome

Number of Blood Samples With Low Levels of Absorbance Via ELISA for Patients (Greater Than 1.5 Ratio Compared to Control Human Serum)
Time frame: 1 year of clinical follow-up

Results and safety

Results posted to the registry on 15 May 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Enrolled	260	156

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

Time frame: 1 year of clinical follow-up. Count of units. Unit: blood draw samples

Measure	Infected n = 20	Not Infected n = 136
Value	48	53

Population analysed: One to three blood sample tests were taken for each participant prior to the one-year post-operative clinical follow-up. Clinical cultures will also be monitored for the one-year post-operative period and compared to the blood sample test results to determine if the test is able to identify patients with positive staphylococcal infection cultures.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 3 months - 1 year depending on if the patient experienced a clinical culture return of staphylococcal-positive. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Unmasked Non-completers	0 of 104 (0%)	0 of 104 (0%)	0 of 104
Infected	0 of 20 (0%)	0 of 20 (0%)	1 of 20
Not Infected	0 of 136 (0%)	0 of 136 (0%)	3 of 136

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 21282411Prabhakara 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.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Robert V O'Toole, MD principal investigator

University of Maryland, College Park

Mark Shirtliff, PhD principal investigator

University of Maryland, College Park

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Open Reduction and Internal Fixation of Extremity Fractures, run by University of Maryland, Baltimore at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Blood Samples With High Levels of Absorbance Via ELISA for Patients (Greater Than 1.5 Ratio Compared to Control Human Serum) (time frame: 1 year of clinical follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03132246, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2020.