Intramedullary Calcium Sulfate Antibiotic Depot for Prevention of Open Fracture Related Infection: A Randomized Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 497
- 试验地点
- 18
- 主要终点
- Number of participants who develop deep surgical site infection (SSI)
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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 18 years and older
- •Type II or III open tibia fracture requiring definitive fixation with intramedullary nail
排除标准
- •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
研究组 & 干预措施
Intramedullary calcium sulfate antibiotic depot prior to Intramedullary nailing (IMN) placement (CS)
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.
干预措施: Vancomycin Hydrochloride (Drug)
Intramedullary calcium sulfate antibiotic depot prior to Intramedullary nailing (IMN) placement (CS)
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.
干预措施: Gentamicin (Drug)
Standard of care intramedullary nail (SN)
Standard of care intramedullary nail
干预措施: Standard Intramedullary Nail (Other)
结局指标
主要结局
Number of participants who develop deep surgical site infection (SSI)
时间窗: Month 12
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.
次要结局
- Time to Union(week 6, month 3, month 6 and month 12)
- Presence of drainage from incision and wounds(week 6, month 3, month 6 and month 12)
- Average Time to Return to Work/Duty(week 6, month 3, month 6 and month 12)
- Veterans RAND 12 Item Health Survey (VR-12) Domain--Pain(week 6, month 3, month 6 and month12)
- Radiographic Union Scale in Tibial fractures (RUST) score(week 6, month 3, month 6, and month 12)
- PROMIS-29 Subscale--Pain Interference(week 6, month 3, month 6 and month12)
- Number of Participants who Return to the Operating Room (OR)(Month 12)
- PROMIS-29 Subscale--Depression(week 6, month 3, month 6 and month12)
- PROMIS-29 Subscale--Sleep Disturbance(week 6, month 3, month 6 and month12)
- Veterans RAND 12 Item Health Survey (VR-12) Domain--Role Limitations(week 6, month 3, month 6 and month12)
- Veterans RAND 12 Item Health Survey (VR-12) Domain--Fatigue(week 6, month 3, month 6 and month12)
- Veterans Rand 12 Item Health Survey (VR-12) Domain --Social Functioning(week 6, month 3, month 6 and month12)
- Veterans Rand 12 Item Health Survey (VR-12) Domain--Mental Health(week 6, month 3, month 6 and month12)
- International Physical Activity Questionnaire (IPAQ)(Baseline, 3 month, 6 month, 12 month)
- PROMIS-29 Subscale--Physical Function(week 6, month 3, month 6 and month12)
- Percentage of Union(week 6, month 3, month 6 and month 12)
- Veterans RAND 12 Item Health Survey (VR-12) Domain --General Health(week 6, month 3, month 6 and month12)
- PROMIS-29 Subscale--Physical Function: Anxiety(week 6, month 3, month 6 and month12)
- PROMIS-29 Subscale--Fatigue(week 6, month 3, month 6 and month12)
- PROMIS-29 Subscale--Ability to Participate in Social Roles and Activities(week 6, month 3, month 6 and month12)
- Veterans RAND 12 Item Health Survey (VR-12) Domain--Physical Functioning(week 6, month 3, month 6 and month12)