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NCT Number: NCT07223684

TDAP in Burn Patients (Group 2)

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 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

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

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

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Nov 3, 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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