An observational study in Sepsis, Burn Injury and Wound Healing, sponsored by Henry M. Jackson Foundation for the Advancement of Military Medicine. Not yet recruiting at 3 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-02-04.
Sponsored by Henry M. Jackson Foundation for the Advancement of Military Medicine · Observational
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.
This is a prospective observational study of adult patients with significant burn injuries. The purpose is to learn more about how the body responds to burns, treatment, and recovery, and to identify factors that may predict complications such as infection or sepsis. By studying patterns in clinical information, blood samples, and tissue samples, researchers aim to develop computer-based models that can improve diagnosis and guide future treatments.
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
2,416 studies on the registry are indexed under Sepsis; 541 are open to participants now.
This study's planned enrollment of 80 is below the median of 150 across 1,162 observational studies indexed under Sepsis.
Browse Sepsis studies →Henry M. Jackson Foundation for the Advancement of Military Medicine is the lead sponsor of 86 studies on the registry; 18 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 2 (29%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Also known as: observational
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.
Time frame: During hospitalization, up to 12 months after discharge
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Analytic code
Time frame: De-identified IPD will be available after primary analyses are complete and results are published, typically within 12-24 months after final data collection.
Access criteria: Data requests will be reviewed by the study steering committee. Investigators will be required to submit a data use agreement and provide documentation of institutional review/ethics oversight.
Start is estimated for May 2026; primary completion for Jun 2027, 13 months later.
Of 491 non-industry observational studies under Sepsis, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 58. This study's planned 13 months is below that.
Counting every sponsor, half of 543 studies reached it within 27 months; a quarter within 12 and three quarters within 56.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Henry M. Jackson Foundation for the Advancement of Military Medicine