Study Results
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Basic Information
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NOT_YET_RECRUITING
80 participants
OBSERVATIONAL
2026-05-15
2027-12-15
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Group 2 - Standard Risk Burn Patients
This group includes adult patients (18 years and older) admitted with significant burn injuries involving more than 10% of their body surface area. These patients are medically stable after injury, without major additional trauma or need for extensive resuscitation.
As part of their participation, small amounts of blood will be 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-will also be included.
Observational Cohort (No Intervention)
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.
Interventions
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Observational Cohort (No Intervention)
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Pregnant patients
* Minors \< 18 years of age
* Prisoners
18 Years
80 Years
ALL
No
Sponsors
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United States Department of Defense
FED
Emory University
OTHER
United States Army Institute of Surgical Research
FED
University of South Florida
OTHER
Uniformed Services University of the Health Sciences
FED
Henry M. Jackson Foundation for the Advancement of Military Medicine
OTHER
Responsible Party
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Principal Investigators
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Seth Schobel-McHugh, PhD
Role: PRINCIPAL_INVESTIGATOR
Uniformed Services University of the Health Sciences
Locations
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University of South Florida - Tampa General Hospital
Tampa, Florida, United States
Emory University-Grady Memorial Hospital
Atlanta, Georgia, United States
United States Army Institute of Surgical Research
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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HT94252320022
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
USUHS.2024-134
Identifier Type: -
Identifier Source: org_study_id
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