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Clinical Trial NCT07249762 for Sepsis, Burn Injury, Wound Healing, Critical Illness, Multiple Organ Dysfunction Syndrome is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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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 40
Clinical Trial NCT07249762 is an observational study for Sepsis, Burn Injury, Wound Healing, Critical Illness, Multiple Organ Dysfunction Syndrome and is currently not yet recruiting. Enrollment is planned to begin on 15 May 2026 and continue until the study accrues 40 participants. Led by Henry M. Jackson Foundation for the Advancement of Military Medicine, this study is expected to complete by 15 December 2027. The latest data from ClinicalTrials.gov was last updated on 4 February 2026.
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 r...Show More
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 treat...Show More
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
Conditions
SepsisBurn InjuryWound HealingCritical IllnessMultiple Organ Dysfunction SyndromePublications
Scientific articles and research papers published about this clinical trial:Other Study IDs
- USUHS.2025-153
- HT94252320022 (Other Grant/Funding Number) (Congressionally Directed Medical Research Programs)
NCT ID Number
Start Date (Actual)
2026-05-15
Last Update Posted
2026-02-04
Completion Date (Estimated)
2027-12-15
Enrollment (Estimated)
40
Study Type
Observational
Status
Not yet recruiting
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
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
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
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 ...Show More | 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. |
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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.
- 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
Henry M. Jackson Foundation for the Advancement of Military MedicineStudy Central Contact
Contact: Seth Schobel-McHugh, PhD, (301) 295-3164, [email protected]
3 Study Locations in 1 Countries
Florida
University of South Florida - Tampa General Hospital, Tampa, Florida, 33606, United States
Jared Troy, MD, Contact, 832-496-1567, [email protected]
Georgia
Emory University-Grady Memorial Hospital, Atlanta, Georgia, 30303, United States
Laura Pruskowski, MD, Contact, 404) 616 - 9852, [email protected]
Texas
United States Army Institute of Surgical Research, Houston, Texas, 78234, United States
Kaitlin Pruskowski, PharmD, Contact, 210-438-7024, [email protected]