Back to resultsProphylactic Antibiotic Coated Nail to Prevent Infection: A Clinical Trial
Primary Purpose
Osteomyelitis Tibia, Tibial Fractures, Open Tibia Fracture
Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Antibiotic coated intramedullary Nail
Standard Intramedullary Nail
Sponsored by
About this trial
This is an interventional prevention trial for Osteomyelitis Tibia focused on measuring Antibiotic-coated nail
Eligibility Criteria
Inclusion Criteria:
- Patients 18 years or older
- Gustilo Type II or III open tibia fracture requiring definitive fixation with intramedullary nail
Exclusion Criteria:
- Less than 18 years of age
- Allergy to vancomycin, tobramycin, or gentamicin
- Unable to speak English or Spanish
- Pregnant and lactating women
- Prisoner
- Unable to follow up for 12 months
Sites / Locations
- University of Florida Gainesville
- Florida Orthopaedic Institute
- Atrium Health Navicent
- University of Kentucky
- University of North Carolina Chapel Hill
- Atrium Health Carolinas Medical CenterRecruiting
- Atrium Health CabarrusRecruiting
- Atrium Health Wake Forest Baptist
- Vanderbilt University Medical Center
- University of Texas Houston
- San Antonio Military Medical Center
- Inova
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Intramedullary Nail
Antibiotic Coated Intramedullary Nail
Arm Description
Traditional standard of care intramedullary (IM) nail
Intramedullary Nail coated with 2 grams of vancomycin and 560 mg gentamicin liquid.
Outcomes
Primary Outcome Measures
Number of Participants who develop deep surgical site infection (SSI)
Number of participants in each group who develop SSI as defined by the criteria establish by the Centers for Disease Control and Prevention (CDC). The CDC criteria define deep as occurring within 30 or 90 days after the procedure. However, we will continue to follow patients for 12 months and document any infections and other complications during this period.
Secondary Outcome Measures
Radiographic Union Scale in Tibial fractures (RUST) score
The RUST score ranges from a minimum score of 4 (definitely not healed) to a maximum score of 12 (completely healed). The final x-ray obtained within a 12-month period following injury will be uploaded to REDCap for review by a blinded panel of investigators from participating sites.
Percentage of Union
Union is the gradual process of bone regeneration after a fracture. Percentage of Union, as determined by the treating surgeon, will be assessed via radiographs. Recorded by surgeon as yes/no answers.
Time to Union
Captured in days
Average Time to Return to Work/Duty
number of days
International Physical Activity Questionnaire (IPAQ)
IPAQ measures the total amount of physical activity completed in a 7 day period by calculating the minutes per week in in each physical activity level domain (walking, moderate and vigorous) by a metabolic equivalent energy (MET) expenditure estimate.
Walking = 3.3 x number of walking minutes x number of walking days Moderate activity= 4.0 x number activity minutes x number of days Vigorous activity = 8 x number of activity minutes x number of days Total = Walking MET-min/wk+moderate MET-min/wk+vigorous MET-min/wk
Number of Subjects Who Have Returned to Work
Determined by asking whether subjects have returned to work
Number of Participants who Return to Operating Room (OR)
PROMIS-29 Subscale--Physical Function
The PROMIS-29 scales will be scored using a T-score metric method. A score of 50 points represents the population average for each scale, and 10 points represent one standard deviation. Higher scores means higher physical function.
PROMIS-29 Subscale--Physical Function: Anxiety
The PROMIS-29 scales will be scored using a T-score metric method. A score of 50 points represents the population average for each scale, and 10 points represent one standard deviation. Higher scores means a higher level of anxiety.
PROMIS-29 Subscale--Depression
The PROMIS-29 scales will be scored using a T-score metric method. A score of 50 points represents the population average for each scale, and 10 points represent one standard deviation. Higher scores means a higher level of depression.
PROMIS-29 Subscale--Fatigue
The PROMIS-29 scales will be scored using a T-score metric method. A score of 50 points represents the population average for each scale, and 10 points represent one standard deviation. Higher scores means a higher level of fatigue.
PROMIS-29 Subscale--Sleep Disturbance
The PROMIS-29 scales will be scored using a T-score metric method. A score of 50 points represents the population average for each scale, and 10 points represent one standard deviation. Higher scores means a higher level of sleep disturbance.
PROMIS-29 Subscale--Pain Interference
The PROMIS-29 scales will be scored using a T-score metric method. A score of 50 points represents the population average for each scale, and 10 points represent one standard deviation. Higher scores means a higher level of pain interference.
PROMIS-29 Subscale--Ability to Participate in Social Roles and Activities
The PROMIS-29 scales will be scored using a T-score metric method. A score of 50 points represents the population average for each scale, and 10 points represent one standard deviation. Higher scores means a higher ability to participate in social roles and activities.
Full Information
NCT ID
NCT05421741
First Posted
June 13, 2022
Last Updated
June 30, 2023
Sponsor
Wake Forest University Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT05421741
Brief Title
Prophylactic Antibiotic Coated Nail to Prevent Infection: A Clinical Trial
Official Title
Prophylactic Antibiotic Coated Nail to Prevent Infection: A Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 15, 2023 (Actual)
Primary Completion Date
December 2026 (Anticipated)
Study Completion Date
December 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This prospective randomized clinical trial will compare outcomes between patients treated primarily with a prophylactic antibiotic coated nail and those treated with traditional standard of care intramedullary (IM) nailing.
Detailed Description
Despite significant treatment advances and protocols to prevent infection, severe open fractures of the lower extremity still have very high rates of deep infection. Infection in an active duty military population increases disability and decreases the likelihood of returning to duty. In addition, infection is one of the main factors associated with rehospitalization. Further, deep infections have not only resulted in increased disability after injury, infection is implicated as one of the main factors in late amputation. Among service members, only 20-25% with a severe open tibia fracture are able to return to active duty. Novel techniques for reducing infection are needed. The proposed study addresses the focus area of fracture-related infections, specifically the prevention of infection.
This prospective randomized clinical trial will compare outcomes between patients treated primarily with a prophylactic antibiotic coated nail and those treated with traditional standard of care intramedullary (IM) nailing.
This prospective randomized clinical trial will compare outcomes between patients treated primarily with a prophylactic antibiotic coated nail and those treated with traditional standard of care intramedullary (IM) nailing.
The target population for the proposed study is patients with severe open tibia fractures (Type II or Type III) who require definitive fixation with intramedullary nail recruited from one of the participating sites during the index hospitalization.
One group will be treated prophylactically using an antibiotic coated intramedullary nail at time of definitive fixation (1CN), while the second group will be treated with traditional standard of care intramedullary nail without antibiotic-coating (SN).
Participant will be followed for 12 months (data capture including patient interviews and clinical data capture from the treatment team and medical record at baseline, 6 weeks, 3 months, 6 months, and 12 months).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteomyelitis Tibia, Tibial Fractures, Open Tibia Fracture
Keywords
Antibiotic-coated nail
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
484 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intramedullary Nail
Arm Type
Active Comparator
Arm Description
Traditional standard of care intramedullary (IM) nail
Arm Title
Antibiotic Coated Intramedullary Nail
Arm Type
Active Comparator
Arm Description
Intramedullary Nail coated with 2 grams of vancomycin and 560 mg gentamicin liquid.
Intervention Type
Drug
Intervention Name(s)
Antibiotic coated intramedullary Nail
Other Intervention Name(s)
Local Gentamicin 560 Powder, Vancomycin 2gm Liquid
Intervention Description
Antibiotic coated intramedullary nail:
A mixture of 40gm bag of acrylic cement, antibiotic powder (Vancomycin 2gm) and 560mg gentamicin liquid. The intramedullary is coated with the mixture using a cement gun tube.
Intervention Type
Other
Intervention Name(s)
Standard Intramedullary Nail
Intervention Description
Standard Intramedullary Nail
Primary Outcome Measure Information:
Title
Number of Participants who develop deep surgical site infection (SSI)
Description
Number of participants in each group who develop SSI as defined by the criteria establish by the Centers for Disease Control and Prevention (CDC). The CDC criteria define deep as occurring within 30 or 90 days after the procedure. However, we will continue to follow patients for 12 months and document any infections and other complications during this period.
Time Frame
Day 30 through month 12
Secondary Outcome Measure Information:
Title
Radiographic Union Scale in Tibial fractures (RUST) score
Description
The RUST score ranges from a minimum score of 4 (definitely not healed) to a maximum score of 12 (completely healed). The final x-ray obtained within a 12-month period following injury will be uploaded to REDCap for review by a blinded panel of investigators from participating sites.
Time Frame
week 6, month 3, month 6, and month 12
Title
Percentage of Union
Description
Union is the gradual process of bone regeneration after a fracture. Percentage of Union, as determined by the treating surgeon, will be assessed via radiographs. Recorded by surgeon as yes/no answers.
Time Frame
week 6, month 3, month 6 and month12
Title
Time to Union
Description
Captured in days
Time Frame
week 6, month 3, month 6 and month12
Title
Average Time to Return to Work/Duty
Description
number of days
Time Frame
week 6, month 3, month 6 and month12
Title
International Physical Activity Questionnaire (IPAQ)
Description
IPAQ measures the total amount of physical activity completed in a 7 day period by calculating the minutes per week in in each physical activity level domain (walking, moderate and vigorous) by a metabolic equivalent energy (MET) expenditure estimate.
Walking = 3.3 x number of walking minutes x number of walking days Moderate activity= 4.0 x number activity minutes x number of days Vigorous activity = 8 x number of activity minutes x number of days Total = Walking MET-min/wk+moderate MET-min/wk+vigorous MET-min/wk
Time Frame
week 6, month 3, month 6 and month12
Title
Number of Subjects Who Have Returned to Work
Description
Determined by asking whether subjects have returned to work
Time Frame
week 6, month 3, month 6 and month12
Title
Number of Participants who Return to Operating Room (OR)
Time Frame
Month 12
Title
PROMIS-29 Subscale--Physical Function
Description
The PROMIS-29 scales will be scored using a T-score metric method. A score of 50 points represents the population average for each scale, and 10 points represent one standard deviation. Higher scores means higher physical function.
Time Frame
week 6, month 3, month 6 and month12
Title
PROMIS-29 Subscale--Physical Function: Anxiety
Description
The PROMIS-29 scales will be scored using a T-score metric method. A score of 50 points represents the population average for each scale, and 10 points represent one standard deviation. Higher scores means a higher level of anxiety.
Time Frame
week 6, month 3, month 6 and month12
Title
PROMIS-29 Subscale--Depression
Description
The PROMIS-29 scales will be scored using a T-score metric method. A score of 50 points represents the population average for each scale, and 10 points represent one standard deviation. Higher scores means a higher level of depression.
Time Frame
week 6, month 3, month 6 and month12
Title
PROMIS-29 Subscale--Fatigue
Description
The PROMIS-29 scales will be scored using a T-score metric method. A score of 50 points represents the population average for each scale, and 10 points represent one standard deviation. Higher scores means a higher level of fatigue.
Time Frame
week 6, month 3, month 6 and month12
Title
PROMIS-29 Subscale--Sleep Disturbance
Description
The PROMIS-29 scales will be scored using a T-score metric method. A score of 50 points represents the population average for each scale, and 10 points represent one standard deviation. Higher scores means a higher level of sleep disturbance.
Time Frame
week 6, month 3, month 6 and month12
Title
PROMIS-29 Subscale--Pain Interference
Description
The PROMIS-29 scales will be scored using a T-score metric method. A score of 50 points represents the population average for each scale, and 10 points represent one standard deviation. Higher scores means a higher level of pain interference.
Time Frame
week 6, month 3, month 6 and month12
Title
PROMIS-29 Subscale--Ability to Participate in Social Roles and Activities
Description
The PROMIS-29 scales will be scored using a T-score metric method. A score of 50 points represents the population average for each scale, and 10 points represent one standard deviation. Higher scores means a higher ability to participate in social roles and activities.
Time Frame
week 6, month 3, month 6 and month12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients 18 years or older
Gustilo Type II or III open tibia fracture requiring definitive fixation with intramedullary nail
Exclusion Criteria:
Less than 18 years of age
Allergy to vancomycin or gentamicin
Unable to speak English or Spanish
Pregnant and lactating women
Prisoner
Unable to follow up for 12 months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rachel Seymour, PhD
Phone
7043552000
Email
Rachel.Seymour@atriumhealth.org
First Name & Middle Initial & Last Name or Official Title & Degree
Christine Churchill, MA
Phone
7043552000
Email
Christine.Churchill@atriumhealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Hsu, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida Gainesville
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Talerico, MD
First Name & Middle Initial & Last Name & Degree
Marissa Pazik
Facility Name
Florida Orthopaedic Institute
City
Temple Terrace
State/Province
Florida
ZIP/Postal Code
33637
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa Stang
First Name & Middle Initial & Last Name & Degree
Hassan Mir, MD
Facility Name
Atrium Health Navicent
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jarrod Dumpe, MD
First Name & Middle Initial & Last Name & Degree
Jarrod Dumpe, MD
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul Matuszewski, MD
First Name & Middle Initial & Last Name & Degree
Paul Matuszewski, MD
Facility Name
University of North Carolina Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27546
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew Chen, MD
First Name & Middle Initial & Last Name & Degree
Malvika Choudhari
Facility Name
Atrium Health Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rachel B Seymour, PhD
First Name & Middle Initial & Last Name & Degree
Christine Churchill, MA
First Name & Middle Initial & Last Name & Degree
Joseph R Hsu, MD
First Name & Middle Initial & Last Name & Degree
Rachel B Seymour, PhD
First Name & Middle Initial & Last Name & Degree
Kevin Phelps, MD
First Name & Middle Initial & Last Name & Degree
Madhav Karunakar, MD
First Name & Middle Initial & Last Name & Degree
Stephen Sims, MD
First Name & Middle Initial & Last Name & Degree
Laurence Kempton, MD
First Name & Middle Initial & Last Name & Degree
Meghan Wally, PhD
First Name & Middle Initial & Last Name & Degree
Susan Odum, PhD
Facility Name
Atrium Health Cabarrus
City
Concord
State/Province
North Carolina
ZIP/Postal Code
28025
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luke Harmer, MD
First Name & Middle Initial & Last Name & Degree
Erica Grochowski, MPH
First Name & Middle Initial & Last Name & Degree
Luke Harmer, MD
First Name & Middle Initial & Last Name & Degree
Laura Blum, MD
Facility Name
Atrium Health Wake Forest Baptist
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martha Holden
First Name & Middle Initial & Last Name & Degree
Eben Carroll, MD
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karen Trochez
First Name & Middle Initial & Last Name & Degree
Daniel Stinner, MD
Facility Name
University of Texas Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephen Warner, MD
First Name & Middle Initial & Last Name & Degree
Natasha Howard
Facility Name
San Antonio Military Medical Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78234
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raymond Kessler, MD
First Name & Middle Initial & Last Name & Degree
Raymond Kessler, MD
Facility Name
Inova
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamad Ray-Zack
First Name & Middle Initial & Last Name & Degree
Greg Gaski, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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Prophylactic Antibiotic Coated Nail to Prevent Infection: A Clinical Trial
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