Intramedullary Calcium Sulfate Antibiotic Depot
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Vancomycin Hydrochloride, Gentamicin, Standard Intramedullary Nail.
- Who it may be relevant to
- Registry conditions: Open tíbia Fracture, Osteomyelitis Tibia, Tibial Fractures. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Intramedullary Calcium Sulfate Antibiotic Depot for Prevention of Open Fracture Related Infection: A Randomized Clinical Trial
Overview
The goal of this randomized clinical trial is to study the best treatment for open lower leg fractures to prevent infection. The main questions it aims to answer is if treating tibia fracture patients with a calcium sulfate antibiotic depot is better at preventing infection that the standard of care.
Detailed description
This research is a randomized clinical trial aimed to reduce the frequency of fracture related infections following open tibia fracture. The proposed test methods for infection reduction is use of an antibiotic depot placed inside the bone at the time of final fracture treatment. This is in addition to standard of care wound care, fracture fixation with intramedullary nailing, and peri-operative systemic antibiotics.
This prospective randomized clinical trial will compare outcomes between patients treated with an antibiotic depot placed inside the bone at the time of final fracture fixation and those treated with traditional standard of care intramedullary nailing.
The target population for the proposed study is patients with severe open tibia fractures (Type II or III) who require definitive fixation with intramedullary nail recruited form one of the participating sites during the index hospitalization.
One group will be treated prophylactically suing a calcium sulfate antibiotic depot at the time of definitive fixation, while the second group will be treated with a standard of care intramedullary nail without the antibiotic depot.
Participants will be followed for 12 months (data capture includes patient interviews and clinical data capture from the treatment team and medical record at baseline, 6 weeks, 3 months, 6 months, and 12 months).
Interventions
- Drug Vancomycin Hydrochloride
The intramedullary calcium sulfate antibiotic depot will be mixed sterilely to include at minimum 20cc calcium sulfate powder mixed with 1g of vancomycin powder and 1.2g of tobramycin powder per 10cc of calcium sulfate. - Drug Gentamicin
The intramedullary calcium sulfate antibiotic depot will be mixed sterilely to include at minimum 20cc calcium sulfate powder mixed with 1g of vancomycin powder and 1.2g of tobramycin powder per 10cc of calcium sulfate. - Other Standard Intramedullary Nail
Standard Intramedullary Nail
Primary outcome measures
- Number of participants who develop deep surgical site infection (SSI) [Time frame: Month 12]
Secondary outcome measures (12)
- Number of Participants who Return to the Operating Room (OR) [Time frame: Month 12]
- Percentage of Union [Time frame: week 6, month 3, month 6 and month 12]
- Time to Union [Time frame: week 6, month 3, month 6 and month 12]
- Radiographic Union Scale in Tibial fractures (RUST) score [Time frame: week 6, month 3, month 6, and month 12]
- Presence of drainage from incision and wounds [Time frame: week 6, month 3, month 6 and month 12]
- Average Time to Return to Work/Duty [Time frame: week 6, month 3, month 6 and month 12]
- International Physical Activity Questionnaire (IPAQ) [Time frame: Baseline, 3 month, 6 month, 12 month]
- PROMIS-29 Subscale--Physical Function [Time frame: week 6, month 3, month 6 and month12]
- PROMIS-29 Subscale--Physical Function: Anxiety [Time frame: week 6, month 3, month 6 and month12]
- PROMIS-29 Subscale--Depression [Time frame: week 6, month 3, month 6 and month12]
- PROMIS-29 Subscale--Fatigue [Time frame: week 6, month 3, month 6 and month12]
- PROMIS-29 Subscale--Sleep Disturbance [Time frame: week 6, month 3, month 6 and month12]
Eligibility criteria
Inclusion criteria
- Patients 18 years and older
- 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 tobramycin
- Hypercalcemia
- Unable to speak English or Spanish
- No email, phone, or other point of contact
- Pregnant and lactating women
- Prisoner
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 10 centers
- Cedars-Sinai — Los Angeles
- Atrium Health Navicent The Medical Center — Macon
- University of Kentucky — Lexington
- Louisiana State University Health Sciences Center — New Orleans
- Atrium Health Carolinas Medical Center — Charlotte
- Atrium Health Cabarrus — Concord
- Atrium Health Wake Forest Baptist Medical Center — Winston-Salem
- Pennsylvania State University — Hershey
- … and 2 more centers
Identifiers
NCT: NCT05766670 · W81XWH-22-10937 · W81XWH-22-10937