Prophylactic Antibiotic Coated Nail to Prevent Infection: A Clinical Trial
- Conditions
- Osteomyelitis TibiaTibial FracturesOpen Tibia Fracture
- Interventions
- Other: Standard Intramedullary NailDrug: Antibiotic coated intramedullary Nail
- Registration Number
- NCT05421741
- Lead Sponsor
- Wake Forest University Health Sciences
- 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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 484
- Patients 18 years or older
- Gustilo Type II or III open tibia fracture requiring definitive fixation with intramedullary nail
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intramedullary Nail Standard Intramedullary Nail Traditional standard of care intramedullary (IM) nail Antibiotic Coated Intramedullary Nail Antibiotic coated intramedullary Nail Intramedullary Nail coated with 2 grams of vancomycin and 560 mg gentamicin liquid.
- Primary Outcome Measures
Name Time Method Number of Participants who develop deep surgical site infection (SSI) Day 30 through month 12 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
Name Time Method Number of Subjects Who Have Returned to Work week 6, month 3, month 6 and month12 Determined by asking whether subjects have returned to work
Number of Participants who Return to Operating Room (OR) Month 12 International Physical Activity Questionnaire (IPAQ) week 6, month 3, month 6 and month12 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/wkPROMIS-29 Subscale--Depression week 6, month 3, month 6 and month12 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 week 6, month 3, month 6 and month12 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.
Percentage of Union week 6, month 3, month 6 and month12 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 week 6, month 3, month 6 and month12 Captured in days
Average Time to Return to Work/Duty week 6, month 3, month 6 and month12 number of days
PROMIS-29 Subscale--Physical Function week 6, month 3, month 6 and month12 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--Sleep Disturbance week 6, month 3, month 6 and month12 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.
Radiographic Union Scale in Tibial fractures (RUST) score week 6, month 3, month 6, and month 12 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.
PROMIS-29 Subscale--Pain Interference week 6, month 3, month 6 and month12 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 week 6, month 3, month 6 and month12 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.
PROMIS-29 Subscale--Physical Function: Anxiety week 6, month 3, month 6 and month12 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.
Trial Locations
- Locations (14)
University of Florida Gainesville
šŗšøGainesville, Florida, United States
Florida Orthopaedic Institute
šŗšøTemple Terrace, Florida, United States
Atrium Health Navicent
šŗšøMacon, Georgia, United States
University of Kentucky
šŗšøLexington, Kentucky, United States
Louisiana State University - University Medical Center New Orleans
šŗšøNew Orleans, Louisiana, United States
University of North Carolina Chapel Hill
šŗšøChapel Hill, North Carolina, United States
Atrium Health Carolinas Medical Center
šŗšøCharlotte, North Carolina, United States
Atrium Health Cabarrus
šŗšøConcord, North Carolina, United States
Atrium Health Wake Forest Baptist
šŗšøWinston-Salem, North Carolina, United States
Penn State Milton S. Hershey Medical Center
šŗšøHershey, Pennsylvania, United States
Vanderbilt University Medical Center
šŗšøNashville, Tennessee, United States
University of Texas Houston
šŗšøHouston, Texas, United States
San Antonio Military Medical Center
šŗšøSan Antonio, Texas, United States
Valley Health System
šŗšøWinchester, Virginia, United States