Status:
RECRUITING
IEEM- Work:Rest Cycles in Burn Survivors- Humidity
Lead Sponsor:
University of Texas Southwestern Medical Center
Collaborating Sponsors:
Texas Health Resources
Conditions:
Hyperthermia
Burn Injury
Eligibility:
All Genders
18-65 years
Brief 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.
Detailed Description
Non-burned control participants and participants who experienced serious burns covering ≥20% of their body surface area will be investigated. Participants will undergo up to three work:rest cycles in ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
August 15 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2031
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06966336
Start Date
August 15 2025
End Date
August 1 2031
Last Update
August 26 2025
Active Locations (1)
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1
IEEM Texas Health Presbyterian Hospital Dallas
Dallas, Texas, United States, 75231