Surgical Critical Care Initiative (SC2i) Tissue and Data Acquisition Protocol (TDAP) in Burn Patients Improving the Robustness and Generalizability of Post-Burn Sepsis Prediction With the Post-Burn Sepsis Digital Twin
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 3
- 主要终点
- Incidence of Sepsis and Other Major Complications After Burn Injury
研究概览
简要总结
This study is following adult patients with serious burn injuries to better understand how their bodies respond to treatment and recovery. Researchers will collect small amounts of blood and tissue samples, along with information already recorded in the medical record, such as vital signs, lab results, and details of surgeries or complications. The goal is to identify patterns that may help predict who is at higher risk for infections or other problems after a burn injury. This information could lead to new tools, including computer-based models, to improve burn care and outcomes in the future. Participation involves providing samples and allowing researchers to review medical records during the hospital stay and up to one year after discharge.
详细描述
This is a prospective observational study of adult patients with significant burn injuries. The purpose is to learn more about how the body responds to burns, treatment, and recovery, and to identify factors that may predict complications such as infection or sepsis. By studying patterns in clinical information, blood samples, and tissue samples, researchers aim to develop computer-based models that can improve diagnosis and guide future treatments.
Patients who are 18 years of age or older with burn injuries involving more than 10% of their body surface area may be eligible. Participants will be asked to give written informed consent before joining the study. Enrollment will occur at several major burn centers in the United States. About 80 patients are expected to participate.
During hospitalization, small blood samples will be collected at scheduled times, and whenever possible, these will be drawn during routine clinical bloodwork to reduce the number of needle sticks. The total amount of blood taken for research will not exceed safe limits (about 125 mL over the entire study period). When surgery is required for wound care, small pieces of tissue that would normally be discarded may also be collected. Information already being collected as part of regular care-such as vital signs, lab results, medications, and details of surgeries and complications-will be included in the research database.
Participants will be followed through their hospital stay and contacted at 6 and 12 months after discharge to check on recovery and health status. All personal health information will remain confidential; data used for analysis will be de-identified.
By combining biological samples with clinical information, this study will create a detailed picture of recovery after burn injury. The results may lead to better ways to detect complications early, personalize treatment, and improve long-term outcomes for burn patients
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Male and female ages 18 years and older (maximum age of 80 years old) with burn injury or related illness requiring surgical care or treatment in a critical care or emergency setting who are being cared for at an SC2i-member clinical care facility (Emory/Grady, USF and USAISR) will be considered for study.
- •Burn Injury >10% TBSA
- •Ability to understand the purposes and risks of the study and willingly give written informed consent, or in the case of incapacitated patients, a willing legally authorized representative (LAR) is able to give written informed consent.
排除标准
- •Any condition that, in the opinion of the attending physician, would place the patient or volunteer subject at undue risk by participating. Specific conditions include but are not limited to anemia prohibitive of phlebotomy, or technical considerations that would prevent acquisition of sufficient tissue for clinical use.
- •Pregnant patients
- •Minors < 18 years of age
- •Prisoners
研究组 & 干预措施
Group 2 - Standard Risk Burn Patients
This group includes adult patients (18 years and older) admitted with significant burn injuries involving more than 10% of their body surface area. These patients are medically stable after injury, without major additional trauma or need for extensive resuscitation.
As part of their participation, small amounts of blood will be collected at scheduled times during hospitalization, and small pieces of skin or tissue normally removed during burn surgery may also be saved. Medical information already recorded in the hospital chart-such as vital signs, lab results, surgeries, and complications-will also be included.
干预措施: Observational Cohort (No Intervention) (Other)
结局指标
主要结局
Incidence of Sepsis and Other Major Complications After Burn Injury
时间窗: During hospitalization, up to 12 months after discharge
Clinical data will be collected from medical records to capture whether patients develop sepsis, organ dysfunction, or other serious complications following burn injury.
次要结局
未报告次要终点