TDAP in Burn Patients (Group 2)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorHenry M. Jackson Foundation for the Advancement of Military Medicine
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
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.
Disqualifiers
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
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Observational Cohort (No Intervention)
Other interventionThis 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.
Treatment groups
80 Participants
are divided into 1 treatment groupGroup A: Group 2 - Standard Risk Burn Patients1 intervention
Trial outcomes
Primary outcomes
1
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 dischargeSponsors and contacts
Click on the lead sponsor to view all of their trials.
Henry M. Jackson Foundation for the Advancement of Military Medicine
Lead sponsor
United States Department of Defense
Collaborator
Emory University
Collaborator
United States Army Institute of Surgical Research
Collaborator
University of South Florida
Collaborator
Uniformed Services University of the Health Sciences
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: