Antibiotic Impregnated Beads in Osteomyelitis

University of Arizona

Status and phase: Begins enrollment this month; Phase 4

Conditions: Antibiotic Impregnated Beads; Osteomyelitis of the Foot; Osteomyelitis of Lower Extremities

Treatments: Device: Calcium sulfate beads (sham beads); Drug: Antibiotic loaded calcium sulfate beads

Study type: Interventional

Funder types: Other

Identifiers

NCT07072923

STUDY00005515

Details and patient eligibility

About

Lower extremity bone infections, such as osteomyelitis, often occur after bone fractures, surgery, or when prosthetic joints or hardware become infected. Treatment usually includes antibiotics, chosen based on the infection's specifics. Options include intravenous (IV) or oral antibiotics, and sometimes local treatment with antibiotic-loaded beads placed directly at the infection site. Traditionally, these beads are made of non-absorbable materials, requiring a second surgery to remove them. However, a newer approach uses absorbable calcium sulfate beads, which can deliver higher antibiotic doses and don't need removal. This study will compare the use of IV and/or antibiotics in combination with absorbable antibiotic calcium sulfate beads with IV and/or oral antibiotics without absorbable beads, which serves as the current standard of care.

Full description

The purpose of this study is to evaluate the effectiveness of absorbable antibiotic beads in treating lower extremity (LE) infections and compare it to the current standard care. The study has several objectives: (1) to compare treatment failure rates between patients receiving intravenous (IV) and/or oral antibiotics plus antibiotic loaded absorbable beads with IV and/or oral antibiotics plus beads without antibiotics (sham beads). The primary question to be answered is whether patients treated with oral and/or IV antibiotics in conjunction with absorbable antibiotic beads have outcome (failure rate) that is not higher than those treated with standard care alone. The study's hypothesis is that the failure rate for patients receiving IV and/or oral antibiotics combined with antibiotic beads will be non-inferior to those receiving the standard care of IV or oral antibiotics without beads. The study will primarily focus on treatment failure rates as a key endpoint to measure effectiveness and compare the two treatment approaches.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients with lower extremity osteoarticular infections with or without hardware

Exclusion criteria

• patients who are hemodynamically unstable or have altered mental status and cannot give consent
• patient per investigators discretion are excluded

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

IV and/or oral antibiotics with local antibiotic loaded calcium sulfate beads

Experimental group

Description:

These will be patient who will receive active systemic antibiotics plus calcium sulfate beads loaded with antibiotics

Treatment:

Device: Calcium sulfate beads (sham beads)

IV and/or oral antibiotics plus calcium sulfate beads without antibiotics (sham beads)

Active Comparator group

Description:

These patients will receive IV and/or oral antibiotics plus sham beads. They will receive antibiotics systemically.

Treatment:

Drug: Antibiotic loaded calcium sulfate beads