Health TrialsbyHealthPanel

Intramedullary Calcium Sulfate Antibiotic Depot

ConditionsOpen tíbia FractureOsteomyelitis TibiaTibial Fractures
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorWake Forest University Health Sciences

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients 18 years and older

Type II or III open tibia fracture requiring definitive fixation with intramedullary nail

Disqualifiers

Less than 18 years of age

Allergy to vancomycin or tobramycin

Hypercalcemia

Unable to speak English or Spanish

Trial design

Design model

Parallel

Treatments tested in this trial

  • Vancomycin Hydrochloride

    Drug

    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.

  • Gentamicin

    Drug

    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.

  • Standard Intramedullary Nail

    Other intervention

    Standard Intramedullary Nail

Treatment groups

497 Participants
are divided into 2 treatment groups
Group A: Intramedullary calcium sulfate antibiotic depot prior to Intramedullary nailing (IMN) placement (CS)Other 2 interventions
Group B: Standard of care intramedullary nail (SN)Other 1 intervention

Trial outcomes

Primary outcomes

1

Number of participants who develop deep surgical site infection (SSI)

Number of participants in each group who develop surgical site infection (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
Month 12

Secondary outcomes

1

Number of Participants who Return to the Operating Room (OR)

Number of Participants who Return to the Operating Room (OR)

Time frame
Month 12
2

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 frame
week 6, month 3, month 6 and month 12
3

Time to Union

Captured in days

Time frame
week 6, month 3, month 6 and month 12
4

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.

Time frame
week 6, month 3, month 6, and month 12

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wake Forest University Health Sciences

Lead sponsor

Source ClinicalTrials.gov
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