Intramedullary Calcium Sulfate Antibiotic Depot

Wake Forest University (WFU)

Status and phase: Enrolling; Phase 3

Conditions: Tibial Fractures; Osteomyelitis Tibia; Open tíbia Fracture

Treatments: Drug: Gentamicin; Other: Standard Intramedullary Nail; Drug: Vancomycin Hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT05766670

W81XWH-22-10937

Details and patient eligibility

About

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.

Full 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).

Enrollment: 497 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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497 participants in 2 patient groups

Intramedullary calcium sulfate antibiotic depot prior to Intramedullary nailing (IMN) placement (CS)

Other group

Description:

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.

Treatment:

Drug: Vancomycin Hydrochloride

Drug: Gentamicin

Standard of care intramedullary nail (SN)

Other group

Description:

Standard of care intramedullary nail

Treatment:

Other: Standard Intramedullary Nail