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

NCT07249762 | Not Yet Recruiting

• 2 other identifiers: USUHS.2025-153HT94252320022
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 3

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.

Conditions

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

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

Outcome Measures

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.

  During hospitalization, up to 12 months after discharge

Study Arms (1)

Group 1 - Minimal Risk Burn Patient

The study includes adult patients (18 years and older) admitted with significant burn injuries involving more than 10% of their total body surface area (TBSA) who require surgical management and/or care within a surgical critical care setting. As part of their participation, small amounts of blood are 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-is also included in the study.

Other: Observational Cohort (No Intervention)

Interventions

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.

Also known as: observational

Group 1 - Minimal Risk Burn Patient

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Henry M. Jackson Foundation for the Advancement of Military Medicine: lead
• 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

Study Sites (3)

University of South Florida - Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Emory University-Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Location

United States Army Institute of Surgical Research

Houston, Texas, 78234, United States

Location

Related Publications (11)

• Yan J, Hill WF, Rehou S, Pinto R, Shahrokhi S, Jeschke MG. Sepsis criteria versus clinical diagnosis of sepsis in burn patients: A validation of current sepsis scores. Surgery. 2018 Dec;164(6):1241-1245. doi: 10.1016/j.surg.2018.05.053. Epub 2018 Jul 23.

  PMID: 30049483 BACKGROUND

• Boehm D, Menke H. Sepsis in Burns-Lessons Learnt from Developments in the Management of Septic Shock. Medicina (Kaunas). 2021 Dec 24;58(1):26. doi: 10.3390/medicina58010026.

  PMID: 35056334 BACKGROUND

• Hampson P, Dinsdale RJ, Wearn CM, Bamford AL, Bishop JRB, Hazeldine J, Moiemen NS, Harrison P, Lord JM. Neutrophil Dysfunction, Immature Granulocytes, and Cell-free DNA are Early Biomarkers of Sepsis in Burn-injured Patients: A Prospective Observational Cohort Study. Ann Surg. 2017 Jun;265(6):1241-1249. doi: 10.1097/SLA.0000000000001807.

  PMID: 27232244 BACKGROUND

• Moins-Teisserenc H, Cordeiro DJ, Audigier V, Ressaire Q, Benyamina M, Lambert J, Maki G, Homyrda L, Toubert A, Legrand M. Severe Altered Immune Status After Burn Injury Is Associated With Bacterial Infection and Septic Shock. Front Immunol. 2021 Mar 2;12:586195. doi: 10.3389/fimmu.2021.586195. eCollection 2021.

  PMID: 33737924 BACKGROUND

• Sadeq F, Poster J, Chu C, Weber J, Lydon M, Begis MD, Sheridan RL, Uygun K. Specific patterns of vital sign fluctuations predict infection and enable sepsis diagnosis in pediatric burn patients. PLoS One. 2022 Feb 7;17(2):e0263421. doi: 10.1371/journal.pone.0263421. eCollection 2022.

  PMID: 35130306 BACKGROUND

• Niggemann P, Rittirsch D, Buehler PK, Schweizer R, Giovanoli P, Reding T, Graf R, Plock JA, Klein HJ. Incidence and Time Point of Sepsis Detection as Related to Different Sepsis Definitions in Severely Burned Patients and Their Accompanying Time Course of Pro-Inflammatory Biomarkers. J Pers Med. 2021 Jul 23;11(8):701. doi: 10.3390/jpm11080701.

  PMID: 34442346 BACKGROUND

• Adams R, Henry KE, Sridharan A, Soleimani H, Zhan A, Rawat N, Johnson L, Hager DN, Cosgrove SE, Markowski A, Klein EY, Chen ES, Saheed MO, Henley M, Miranda S, Houston K, Linton RC, Ahluwalia AR, Wu AW, Saria S. Prospective, multi-site study of patient outcomes after implementation of the TREWS machine learning-based early warning system for sepsis. Nat Med. 2022 Jul;28(7):1455-1460. doi: 10.1038/s41591-022-01894-0. Epub 2022 Jul 21.

  PMID: 35864252 BACKGROUND

• Henry KE, Adams R, Parent C, Soleimani H, Sridharan A, Johnson L, Hager DN, Cosgrove SE, Markowski A, Klein EY, Chen ES, Saheed MO, Henley M, Miranda S, Houston K, Linton RC 2nd, Ahluwalia AR, Wu AW, Saria S. Factors driving provider adoption of the TREWS machine learning-based early warning system and its effects on sepsis treatment timing. Nat Med. 2022 Jul;28(7):1447-1454. doi: 10.1038/s41591-022-01895-z. Epub 2022 Jul 21.

  PMID: 35864251 BACKGROUND

• Tran NK, Albahra S, Pham TN, Holmes JH 4th, Greenhalgh D, Palmieri TL, Wajda J, Rashidi HH. Novel application of an automated-machine learning development tool for predicting burn sepsis: proof of concept. Sci Rep. 2020 Jul 23;10(1):12354. doi: 10.1038/s41598-020-69433-w.

  PMID: 32704168 BACKGROUND

• Rashidi HH, Sen S, Palmieri TL, Blackmon T, Wajda J, Tran NK. Early Recognition of Burn- and Trauma-Related Acute Kidney Injury: A Pilot Comparison of Machine Learning Techniques. Sci Rep. 2020 Jan 14;10(1):205. doi: 10.1038/s41598-019-57083-6.

  PMID: 31937795 BACKGROUND

• von Lilienfeld-Toal M, Dietrich MP, Glasmacher A, Lehmann L, Breig P, Hahn C, Schmidt-Wolf IG, Marklein G, Schroeder S, Stuber F. Markers of bacteremia in febrile neutropenic patients with hematological malignancies: procalcitonin and IL-6 are more reliable than C-reactive protein. Eur J Clin Microbiol Infect Dis. 2004 Jul;23(7):539-44. doi: 10.1007/s10096-004-1156-y. Epub 2004 Jun 22.

  PMID: 15221617 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

During this study, small amounts of blood will be collected from participants at scheduled times. Whenever possible, these samples will be taken during routine blood draws to avoid extra needle sticks. The total amount of blood collected for research will be limited to safe levels. If participants need surgery to remove damaged skin, small pieces of tissue that would normally be thrown away may also be saved for research. These samples will be used to study how the body responds to burn injury and recovery. All samples will be labeled with a study code only, not personal identifiers.

MeSH Terms

Conditions

Sepsis; Burns; Critical Illness; Multiple Organ Failure; Infections; Respiratory Distress Syndrome

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries; Disease Attributes; Shock; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Central Study Contacts

Seth Schobel-McHugh, PhD

CONTACT

(301) 295-3164; seth.schobel-mchugh@usuhs.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 25, 2025
• Study Start: May 15, 2026
• Primary Completion (Estimated): June 15, 2027
• Study Completion (Estimated): December 15, 2027
• Last Updated: February 4, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: De-identified IPD will be available after primary analyses are complete and results are published, typically within 12-24 months after final data collection.
• Access Criteria: Data requests will be reviewed by the study steering committee. Investigators will be required to submit a data use agreement and provide documentation of institutional review/ethics oversight.

Locations

US (3)