NCT07249762

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

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

Interventions

Type	Name	Description
OTHER	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.

Timeline

• Start date: 2026-05-15
• Primary completion: 2027-06-15
• Completion: 2027-12-15
• First posted: 2025-11-25
• Last updated: 2026-02-04

Locations

3 sites across 1 country: United States