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Recruiting
NCT06966336
IEEM- Work:Rest Cycles in Burn Survivors- Humidity
Conditions: Hyperthermia, Burn Injury
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: Yes
Enrollment: 70
Sponsor: University of Texas Southwestern Medical Center
Location: IEEM Texas Health Presbyterian Hospital Dallas Dallas Texas
Summary
The purpose of this project is to identify the effects of a severe burn injuries in humans on core temperature responses during work:rest cycles while in a heated environment.
Eligibility Criteria
Inclusion Criteria for Non-burned Individuals:
* Participants must be free of any significant underlying medical problems based upon a detailed medical history and physical exam, and normal resting electrocardiogram. Participants must be between the ages of 18 and 65.
Exclusion Criteria for Non-burned Individuals:
* Known heart disease; other chronic medical conditions requiring regular medical therapy including cancer, diabetes, neurological diseases, and uncontrolled hypertension, lung disease, etc.; as well as serious abnormalities detected on routine screening. Current smokers, as well as individuals who regularly smoked within the past 3 years will be excluded. Participants may also be excluded if body mass index is ≥ 31 kg/m2 will likewise be excluded. Participants must not have had a serious burn injury requiring more than 1 night stay in the hospital.
Inclusion Criteria for Individuals with up to 40% of their body surface area burned (moderate burn group):
\- Participants must be free of any significant underlying medical problems based upon a detailed medical history and physical exam, and normal resting electrocardiogram. Participants who have sustained a burn injury must have a burn covering 20-40% of their body surface area and 50% of those burns must be full-thickness burns requiring skin grafts. Participants must be between the ages of 18 and 65.
Exclusion Criteria for Individuals with up to 40% of their body surface area burned (moderate burn group):
\- Known heart disease; other chronic medical conditions requiring regular medical therapy including cancer, diabetes, neurological diseases, and uncontrolled hypertension, lung disease, etc.; as well as serious abnormalities detected on routine screening. Current smokers, as well as individuals who regularly smoked within the past 3 years will be excluded. Participants may also be excluded if body mass index is ≥ 31 kg/m2 will likewise be excluded.
Inclusion Criteria for Individuals with greater than 40% of their body surface area burned (large burn group):
\- Participants must be free of any significant underlying medical problems based upon a detailed medical history and physical exam, and normal resting electrocardiogram. Participants who have sustained a burn injury must have a burn covering more than 40% of their body surface area and 50% of those burns must be full-thickness burns requiring skin grafts. Participants must be between the ages of 18 and 65.
Exclusion Criteria for Individuals with greater than 40% of their body surface area burned (large burn group):
\- Known heart disease; other chronic medical conditions requiring regular medical therapy including cancer, diabetes, neurological diseases, and uncontrolled hypertension, lung disease, etc.; as well as serious abnormalities detected on routine screening. Current smokers, as well as individuals who regularly smoked within the past 3 years will be excluded. Participants may also be excluded if body mass index is ≥ 31 kg/m2 will likewise be excluded.
Source: ClinicalTrials.gov (NCT06966336). StuddyBuddy aggregates publicly available trial information.