Acute Application Of Intrawound Antibiotic Powder In Open Extremity Fracture Wounds
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Incidence of Surgical Site Infection During the Post-operative Follow-up Period
研究概览
简要总结
The purpose of this study is to help determine the best treatment for severe injures like open fracture wounds.
Some broken bone injuries can be more likely to get an infection. It is mostly due to the way they were injured. Surgical site infection in the orthopedic surgery population is a big public health issue. Wound infections result in both longer length of hospital stay and total cost of care. This study will be using an antibiotic called Vancomycin or Tobramycin in a powder form.
详细描述
The investigators aim to investigate the effectiveness of preoperative intrawound antibiotic powder in preventing infection and reducing bacterial burden after open fracture.
The investigators hypothesize that the participants who receive preoperative intrawound antibiotic powder will have fewer superficial and deep surgical site infections compared to participants who do not receive the antibiotic powder. The investigators also anticipate that the application of the antibiotic powder to open fracture wounds preoperatively will decrease the bacterial burden.
Sample swabs will be analyzed using the 16S metagenomics sequencing on the Illumina platform. Both RNA and DNA extracts will be utilized to identify and quantify the bacterial load in the wound bed at the time immediately prior to surgical debridement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
This will be a single-blind study as only the participants will be blinded to the treatment.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject or proxy willing and able to provide written informed consent.
- •Age between 18 years and 80 years (inclusive), with an upper or lower extremity Gustilo Type II, IIIA, or IIIB open fractures requiring debridement and internal fixation.
- •Open extremity fractures
- •Time from injury to study intervention 24 hours or less
排除标准
- •Individuals under the age of 18 years or over 80 years
- •Type I or IIIC open fractures
- •Over 24 hours from time of injury
- •Subjects who have received acute operative care of the open fracture at an outside facility prior to presenting at the Emergency Department.
- •Open fractures distal to the wrist and midfoot
- •History of chronic infection in the extremity involved.
- •Subjects who are currently pregnant
- •Subjects who are Prisoners
- •Subjects with a known allergy to vancomycin or tobramycin
- •Subjects with a condition or social circumstances that would reduce adherence and follow-up.
- •Subjects Participating in other clinical research involving investigational antimicrobial products within 30 days of randomization.
研究组 & 干预措施
Vancomycin
Subjects randomized to the Intervention arm will receive standard of care plus 1 gram of vancomycin powder applied topically to the wound bed before the dressing is applied. Intervention will occur in the emergency room prior to surgical intervention.
干预措施: Vancomycin (Drug)
Tobramycin
Subjects randomized to the Intervention arm will receive standard of care plus 1.2 grams of tobramycin powder applied topically to the wound bed before the dressing is applied. Intervention will occur in the emergency room prior to surgical intervention.
干预措施: Tobramycin (Drug)
Control
Subjects randomized to the Control Arm will receive standard of care open fracture wound care (no powder) by the clinical team.
结局指标
主要结局
Incidence of Surgical Site Infection During the Post-operative Follow-up Period
时间窗: Within 6 months of injury date
The percentage of participants who develop an infection at the surgical site following debridement and fixation at the follow up period.
次要结局
- Presence of Fracture Nonunion(Within 1 year of injury date)