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TDAP in Burn Patients (Group 2)

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07223684
Enrollment
80
Registered
2025-11-03
Start date
2026-05-15
Completion date
2027-12-15
Last updated
2026-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burn Injury, Critical Illness, Multiple Organ Dysfunction Syndrome, Sepsis, Wound Healing

Keywords

Burn Infection, Sepsis, Critical Illness, Thermal Injury, Infection, Multiple Organ Dysfunction Syndrome (MODS), Acute Respiratory Distress Syndrome (ARDS), Wound Healing, Biomarkers, Digital Twin Model, Predictive Analytics, Surgical Critical Care

Brief summary

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.

Detailed description

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

Interventions

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.

Sponsors

Henry M. Jackson Foundation for the Advancement of Military Medicine
Lead SponsorOTHER
United States Department of Defense
CollaboratorFED
Emory University
CollaboratorOTHER
United States Army Institute of Surgical Research
CollaboratorFED
University of South Florida
CollaboratorOTHER
Uniformed Services University of the Health Sciences
CollaboratorFED

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of Sepsis and Other Major Complications After Burn InjuryDuring hospitalization, up to 12 months after dischargeClinical data will be collected from medical records to capture whether patients develop sepsis, organ dysfunction, or other serious complications following burn injury.

Countries

United States

Contacts

CONTACTSeth Schobel-McHugh, PhD
seth.schobel-mchugh@usuhs.edu(301) 295-3164
PRINCIPAL_INVESTIGATORSeth Schobel-McHugh, PhD

Uniformed Services University of the Health Sciences

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026