SepsisNCT07249762
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
An observational study of Sepsis and Burn Injury, run by Henry M. Jackson Foundation for the Advancement of Military Medicine at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sepsis, Burn Injury, Wound Healing
- How many people
- 40 participants
- Where
- 3 sitesUnited States
- Study dates
- 15 May 2026to 15 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites
Emory University-Grady Memorial Hospital
Atlanta, Georgia, 30303
Laura Pruskowski, MD, 404) 616 - 9852, laura.s.johnson@emory.edu
United States Army Institute of Surgical Research
Houston, Texas, 78234
Kaitlin Pruskowski, PharmD, 210-438-7024, kaitlin.a.pruskowski.civ@health.mil
University of South Florida - Tampa General Hospital
Tampa, Florida, 33606
Jared Troy, MD, 832-496-1567, jtroy@usf.edu
About this study
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.
Read the detailed description
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.
- Being tested
- Observational Cohort (No Intervention)
- 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
- Medical subject headings
- Sepsis, Burns, Critical Illness, Multiple Organ Failure, Infections, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational Cohort (No Intervention)Other
Also called observational
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Observational Cohort (No Intervention) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During hospitalization, up to 12 months after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start15 May 2026 (estimated)
- Primary completion15 Jun 2027 (estimated)
- Study completion15 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henry M. Jackson Foundation for the Advancement of Military Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense, Emory University, United States Army Institute of Surgical Research, University of South Florida, Uniformed Services University of the Health Sciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07249762
- Sponsor's protocol ID
- USUHS.2025-153
- Other IDs
- HT94252320022
- Status last verified
- Nov 2025
- First submitted
- 18 Nov 2025
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD), including clinical information and research sample data, may be shared with qualified researchers. Data will be stripped of direct identifiers, and a coded study ID will be used. The code key will remain at the enrolling site and will not be shared.
Publications
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.
PubMed 30049483Boehm 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.
PubMed 35056334Hampson 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.
PubMed 27232244Moins-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.
PubMed 33737924Sadeq 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.
PubMed 35130306Niggemann 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.
PubMed 34442346Adams 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.
PubMed 35864252Henry 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.
PubMed 35864251Tran 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.
PubMed 32704168Rashidi 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.
PubMed 31937795von 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.
PubMed 15221617
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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. Group 1
- ClinicalTrials.gov ID
- NCT07249762
- Acronym / sponsor ID
- USUHS.2025-153
- Keywords
- Burn Infection, Sepsis, Critical Illness, Thermal Injury, Infection, Multiple Organ Dysfunction Syndrome (MODS), Acute Respiratory Distress Syndrome (ARDS), Wound Healing
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Henry M. Jackson Foundation for the Advancement of Military MedicineUniversity, hospital or other
- Collaborators
- United States Department of Defense, Emory University, United States Army Institute of Surgical Research, University of South Florida, Uniformed Services University of the Health Sciences
- Study start
- 15 May 2026 (estimated)
- Primary completion
- 15 Jun 2027 (estimated)
- Study completion
- 15 Dec 2027 (estimated)
- First posted
- 25 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Minimal Risk Burn Patient | – | Other: Observational Cohort (No Intervention)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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational Cohort (No Intervention)Also: observationalThis 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 | Group 1 - Minimal Risk Burn Patient |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Background: PubMed 30049483Yan 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.
- Background: PubMed 35056334Boehm 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.
- Background: PubMed 27232244Hampson 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.
- Background: PubMed 33737924Moins-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.
- Background: PubMed 35130306Sadeq 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.
- Background: PubMed 34442346Niggemann 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.
- Background: PubMed 35864252Adams 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.
- Background: PubMed 35864251Henry 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.
- Background: PubMed 32704168Tran 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.
- Background: PubMed 31937795Rashidi 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.
- Background: PubMed 15221617von 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.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD), including clinical information and research sample data, may be shared with qualified researchers. Data will be stripped of direct identifiers, and a coded study ID will be used. The code key will remain at the enrolling site and will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Burn Injury, run by Henry M. Jackson Foundation for the Advancement of Military Medicine at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Seth Schobel-McHugh, PhD ((301) 295-3164, seth.schobel-mchugh@usuhs.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Sepsis and Other Major Complications After Burn Injury (time frame: During hospitalization, up to 12 months after discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07249762, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.