Assessment of Severe Extremity Wound Bioburden at the Time of Definitive Wound Closure or Coverage

Open Fracture Clinical Trial

— Bioburden  

Official title:

Assessment of Severe Extremity Wound Bioburden at the Time of Definitive Wound Closure or Coverage: Correlation With Subsequent Post-Closure Deep Wound Infection: Bioburden Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01496014
• Other study ID #: A-15737.5a
• Status: Completed
• Start date: September 2011
• Est. completion date: June 30, 2022

Study information

• Verified date: July 2022
• Source: Major Extremity Trauma Research Consortium
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to characterize the bacteria in the wound "bioburden" at the time of definitive wound coverage/closure of severe tibia fractures in both the military and civilian populations.

Description:

Infection remains the most common and significant complication following high energy fractures. The strategies used in the prevention of deep infection following severe open fracture wounds have remained constant for the past 20 years.

This project is designed to analyze the microbiology profiles of wounds from severe tibia fractures at closure by comparing two methods: routine microbiology techniques and PCR methods using the Ibis T5000 Biosensor System. The results from both identification methods will be compared to the pathogens associated with deep surgical site infections that occur post closure of the wound. Currently it is unknown which of these methods will yield information that can lower complication rates and better function of the leg. Our goal is to perform a multi-center, prospective cohort study of wound bacterial bioburden and associated antibiotic care in severe open lower extremity fractures.

Primary Aim: In a subset of 60 patients, compare the bioburden, as detected by Ibis technology, from each of three sampling techniques (deep tissue; soft tissue composite; composite of tissue from the length and depth of the wound). Samples obtained using the most effective technique identified in this step will be processed using Ibis in subsequent tissue analysis. Effectiveness is defined as the ability to identify key wound infection-causing pathogens.

Primary Hypothesis: The composite sampling approach will be the most effective technique.

Secondary Aim: Characterize the wound bioburden at the time of definitive wound closure or coverage using the Ibis T5000 Biosensor System PCR technology as compared to standard microbiology techniques.

Hypothesis 2: The Ibis technology will detect more species of pathogens than standard microbiology techniques. The percent of patients for whom Ibis will detect all species identified by standard microbiology will be greater than 95%.

Specific Aim 3: Characterize the wound bioburden in the patients who develop deep infection within one year of wound closure, and determine the association between infecting pathogens with initial wound closure bioburden as measured jointly by Ibis and standard microbiology techniques.

Specific Aim 4: Document the variability in antibiotic selection and duration, and examine the impact of this selection on subsequent deep infection.

Hypothesis 4a: Among patients treated with antibiotic regimens that are appropriate for the pathogens identified by standard microbiology, there will be a lower probability of deep infection than among those patients who received inappropriate antibiotic regimens.

Hypothesis 4b: Among patients treated with antibiotic regimens that are appropriate for the pathogens identified by Ibis, there will be a lower probability of deep infection than among those patients who received inappropriate antibiotic regimens.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: June 30, 2022
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

1. All open Grade III tibia fractures (plateau, shaft, pilon) requiring a second procedure following fixation, or traumatic transtibial amputations requiring delayed primary closure, skin grafting and/ or flap coverage.

2. Ages 18 - 64 years inclusive

3. Patients may have risk factors for infection including diabetes, immunosuppression from steroids or other medications, HIV, or other infections.

4. Patients may have a traumatic brain injury.

5. Patients may have other fractures including spine, upper extremity fractures, contralateral lower extremity injuries, ipsilateral pelvis, hip, femur or foot injuries.

6. Patients may be treated initially at an outside institution prior to transfer to the study institution, as long as the definitive fixation was not performed prior to entrance into the study.

7. Patients with bilateral injuries that meet inclusion criteria may be included, but only the limb rated as "more severe" by the treating surgeon will be enrolled in the study.

8. Patients may have co-existing non-tibial infection, with or without antibiotic treatment.

9. Patients may have an existing infection of the surgical wound under treatment at the time of wound closure.

10. Patients may be definitively fixed using any method (nail, plate, ex fix)

11. Patients may have a fasciotomy

Exclusion Criteria:

1. Patient speaks neither English nor Spanish

2. Patient is a prisoner

3. Patient has been diagnosed with a severe psychiatric condition

4. Patient is intellectually challenged without adequate family support

5. Patient lives outside the hospital's catchment area

6. Patients with planned follow-up at another medical center

Related Conditions & MeSH terms

• Fractures, Open
• Open Fracture

Locations

Country	Name	City	State
United States	Emory University Dept of Orthopaedics	Atlanta	Georgia
United States	University of Maryland, R Adams Cowley Shock Trauma Center	Baltimore	Maryland
United States	Walter Reed Military Medical Center	Bethesda	Maryland
United States	Walter Reed National Military Medical Center	Bethesda	Maryland
United States	Boston Medical Center	Boston	Massachusetts
United States	Carolinas Medical Center	Charlotte	North Carolina
United States	University of Virginia	Charlottesville	Virginia
United States	MetroHealth Medical Center	Cleveland	Ohio
United States	Grant Medical Center	Columbus	Ohio
United States	Ohio State University Medical Center	Columbus	Ohio
United States	Denver Health and Hospital Authority	Denver	Colorado
United States	Duke University Hospital	Durham	North Carolina
United States	San Antonio Miliary Medical Center	Fort Sam Houston	Texas
United States	Orthopaedic Associates of Michigan, Spectrum Health	Grand Rapids	Michigan
United States	Penn State University M.S. Hershey Medical Center	Hershey	Pennsylvania
United States	UT Health: The University of Texas Health Science Center at Houston Medical School	Houston	Texas
United States	OrthoIndy at St Vincent	Indianapolis	Indiana
United States	University of Iowa Hospitals & Clinics	Iowa City	Iowa
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	University of Miami Ryder Trauma Center	Miami	Florida
United States	Hennepin County Medical Center / Minneapolis	Minneapolis	Minnesota
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Louisiana State University	New Orleans	Louisiana
United States	University of Oklahoma	Oklahoma City	Oklahoma
United States	Temple University Hospital	Philadelphia	Pennsylvania
United States	Allegheny General Hosptial	Pittsburgh	Pennsylvania
United States	Naval Medical Center Portsmouth	Portsmouth	Virginia
United States	Brown University/Rhode Island Hospital	Providence	Rhode Island
United States	University of Rochester	Rochester	New York
United States	Barnes Jewish Hospital	Saint Louis	Missouri
United States	St. Louis Medical Center	Saint Louis	Missouri
United States	Regions Hospital	Saint Paul	Minnesota
United States	University of Utah	Salt Lake City	Utah
United States	Naval Medical Center San Diego	San Diego	California
United States	UCSF Medical Center	San Francisco	California
United States	Harborview Medical Center	Seattle	Washington
United States	Florida Orthopaedic Institute	Tampa	Florida
United States	Scott and White Memorial Hospital	Temple	Texas
United States	Wake Forest University Baptist Medical Center	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Major Extremity Trauma Research Consortium	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infection	The presence of a deep surgical site infection will be defined by the criteria of the Centers for Disease Control. Deep SSI occurs within 30 days after the operation if no implant is left in place, or within one year if implant is in place and the infection appears to be related to the operation.	1 year
Secondary	Classification of Appropriate Antibiotic Care	An expert panel consisting of the study PI, two additional orthopaedic trauma surgeons and at least three infectious disease experts will be convened to develop a classification grid for the most common and/or expected microbial species to be found in this study and the related antibiotic treatment regimens used in the initial care of these patients. For each microbial species, the expert panel will classify a given antibiotic regimen as "appropriate" and "not appropriate", based on the best available published data.	1 year