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

Part of paid clinical trials in Tampa, Florida.

Sponsor
Henry M. Jackson Foundation for the Advancement of Military Medicine
Study ID
NCT07249762
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
May 15, 2026
Status verified
Nov 2025
Primary completion
Jun 15, 2027
Completion
Dec 15, 2027

Study Design

Enrollment
40 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

Incidence of Sepsis and Other Major Complications After Burn Injury [ Time Frame: During hospitalization, up to 12 months after discharge ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
University of South Florida - Tampa General HospitalTampaFlorida33606
Jared Troy, MD
832-496-1567
Emory University-Grady Memorial HospitalAtlantaGeorgia30303
Laura Pruskowski, MD
404) 616 - 9852
United States Army Institute of Surgical ResearchHoustonTexas78234
Kaitlin Pruskowski, PharmD
210-438-7024

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