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. Group 1

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorHenry M. Jackson Foundation for the Advancement of Military Medicine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Burn Injury >10% TBSA with who have a recognized concurrent or impending risk for clinical decompensation.

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.

Ability to understand the purposes and risks of the study and to provide informed consent, either through written documentation or in accordance with the IRB-approved Waiver of Documentation of Consent procedures. In the case of incapacitated patients, a willing Legally Authorized Representative (LAR) may provide informed consent in accordance with written documentation or under the provisions of the approved Waiver of Documentation of Consent.

Disqualifiers

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

Trial population

This is a prospective observational study of patients with burn wounds \>10% TBSA requiring surgical management and/or management within a surgical critical care setting.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Observational Cohort (No Intervention)

    Other intervention

    This is not a treatment trial-no drugs, devices, or procedures are being tested. Participants receive standard burn care only. The research involves collecting blood and tissue samples (when clinically indicated) and reviewing medical record data.

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Group 1 - Minimal Risk Burn Patient1 intervention

Trial outcomes

Primary outcomes

1

Incidence of Sepsis and Other Major Complications After Burn Injury

Clinical data will be collected from medical records to capture whether patients develop sepsis, organ dysfunction, or other serious complications following burn injury.

Time frame
During hospitalization, up to 12 months after discharge

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Henry M. Jackson Foundation for the Advancement of Military Medicine

Lead sponsor

United States Department of Defense

Collaborator

Emory University

Collaborator

United States Army Institute of Surgical Research

Collaborator

University of South Florida

Collaborator

Uniformed Services University of the Health Sciences

Collaborator

This trial is not recruiting at the moment. You can still explore other options: