Utility of Antibiotic Impregnated Beads in Lower Extremity Osteomyelitis
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- End of Therapy - Clinical Failure
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Randomization table will be prepared with treatment allocation specified in sealed envelopes. Participants are assigned a study number sequentially after consent is obtained. The surgeon and infectious disease specialist will develop a plan for IV and/or oral antibiotics based on culture results from the initial surgery.
In addition, they will develop a plan for local antibiotics to be incorporated in the calcium sulfate beads. Antibiotics will actually be added only if the patient is assigned to the treatment group. The Investigator will then pull the envelope for the prospective study number and obtain the assigned treatment (antibiotic loaded beads versus sham beads). The calcium sulfate beads (with or without antibiotics will be placed during the second surgical procedure.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with lower extremity osteoarticular infections with or without hardware
排除标准
- •patients who are hemodynamically unstable or have altered mental status and cannot give consent
- •patient per investigators discretion are excluded
研究组 & 干预措施
IV and/or oral antibiotics with local antibiotic loaded calcium sulfate beads
These will be patient who will receive active systemic antibiotics plus calcium sulfate beads loaded with antibiotics
干预措施: Calcium sulfate beads (sham beads) (Device)
IV and/or oral antibiotics plus calcium sulfate beads without antibiotics (sham beads)
These patients will receive IV and/or oral antibiotics plus sham beads. They will receive antibiotics systemically.
干预措施: Antibiotic loaded calcium sulfate beads (Drug)
结局指标
主要结局
End of Therapy - Clinical Failure
时间窗: End of Therapy (usually 4-6 weeks)
1. Presence of at least one clinical criterium for failure (frank pus adjacent to bone or implant or draining sinus tract), OR 2. phenotypically indistinguishable bacteria isolated from two or more deep-tissue samples or a single closed aspirate or biopsy OR 3. histologic criteria including presence of characteristic inflammatory infiltrate or microorganisms.
次要结局
未报告次要终点