Actively Recruiting
Intramedullary Calcium Sulfate Antibiotic Depot for Prevention of Open Fracture Related Infection: A Randomized Clinical Trial
Led by Wake Forest University Health Sciences · Updated on 2025-12-15
497
Participants Needed
10
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the best treatment to prevent infection in patients with open lower leg fractures, specifically severe open tibia fractures (Type II or III). This randomized clinical trial aims to find out if using a calcium sulfate antibiotic depot inside the bone during final fracture treatment can better prevent infections compared to the standard care. The study is sponsored by Wake Forest University Health Sciences and is designed to improve outcomes for patients requiring intramedullary nailing for tibia fractures. Participants are randomly assigned to one of two groups: one receiving a calcium sulfate antibiotic depot mixed with vancomycin and tobramycin placed inside the bone along with the standard intramedullary nail, and the other receiving the standard intramedullary nail without the antibiotic depot. The antibiotic depot is prepared using at least 20cc of calcium sulfate powder mixed with specific doses of antibiotics. Both groups receive usual wound care and systemic antibiotics during surgery. During the 12-month follow-up, participants will be monitored at baseline, 6 weeks, 3 months, 6 months, and 12 months with interviews and medical record reviews. Researchers will measure the number of participants who develop deep surgical site infections, time and percentage of bone healing, pain, physical function, mental health, and other health-related quality of life outcomes. Safety and recovery progress will also be tracked throughout the study period.
CONDITIONS
Brief Title
Intramedullary Calcium Sulfate Antibiotic Depot
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients 18 years and older
- Type II or III open tibia fracture requiring definitive fixation with intramedullary nail
You will not qualify if you...
- Less than 18 years of age
- Allergy to vancomycin or tobramycin
- Hypercalcemia
- Unable to speak English or Spanish
- No email, phone, or other point of contact
- Pregnant and lactating women
- Prisoner
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - During index hospitalization
Participants undergo definitive fixation of their open tibia fracture with an intramedullary nail. Some participants receive an additional antibiotic depot placed inside the bone at the time of fixation.
1 procedure visit (in-person)
Duration - 12 months
Participants are followed for 12 months with interviews and clinical data collection to monitor recovery, infection, and fracture healing.
Visits at baseline, 6 weeks, 3 months, 6 months, and 12 months
Trial Site Locations
Total: 10 locations
1
Cedars-Sinai
Los Angeles, California, United States, 90048
Actively Recruiting
2
Atrium Health Navicent The Medical Center
Macon, Georgia, United States, 31201
Actively Recruiting
3
University of Kentucky
Lexington, Kentucky, United States, 40508
Not Yet Recruiting
4
Louisiana State University Health Sciences Center
New Orleans, Louisiana, United States, 70112
Actively Recruiting
5
Atrium Health Carolinas Medical Center
Charlotte, North Carolina, United States, 28204
Actively Recruiting
6
Atrium Health Cabarrus
Concord, North Carolina, United States, 28025
Actively Recruiting
7
Atrium Health Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
8
Pennsylvania State University
Hershey, Pennsylvania, United States, 17033
Actively Recruiting
9
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Not Yet Recruiting
10
Valley Health
Winchester, Virginia, United States, 22601
Actively Recruiting
Research Team
C
Christine Churchill, MA
R
Rachel B Seymour, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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