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NCT Number: NCT07249762

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of South Florida - Tampa General Hospital, Tampa, Florida, United States

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About this study

This is a prospective observational study of adult patients with significant burn injuries. The purpose is to understand the body responses to significant burns, treatment, and recovery and to identify factors that predict complications like infection or sepsis. By studying patterns in clinical information, blood, and tissue samples to develop computer-based models intended to improve diagnosis and guide future treatments.

Eligible participants are males and females between 18 and 80 years old with burn injuries involving more than 10% of their total body surface area (TBSA) who require care in a critical care or emergency setting at an SC2i-member facility (e.g., Emory, Grady, USF, USAISR). All participants or their Legally Authorized Representatives (LARs) must provide informed consent. About 40 patients are expected to participate.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Observational Cohort (No Intervention)

Other

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.

Other names: observational

Primary outcomes

  1. Incidence of Sepsis and Other Major Complications After Burn Injury

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Seth Schobel-McHugh, PhD

CONTACT

[email protected]

(301) 295-3164

Sponsors and collaborators

Lead sponsor

Henry M. Jackson Foundation for the Advancement of Military Medicine

Other

Collaborators

  • Emory University
  • Uniformed Services University of the Health Sciences
  • United States Army Institute of Surgical Research
  • United States Department of Defense
  • University of South Florida

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Nov 25, 2025
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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