An interventional study of Control (no cooling modalities) and Water Spray in Burn Injury, sponsored by University of Texas Southwestern Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-24.
Sponsored by University of Texas Southwestern Medical Center · Not applicable, Interventional, and Other
This project will identify the efficacy of cooling modalities aimed to attenuate excessive elevations in skin and internal body temperatures, and associated indices of cardiovascular stress, during physical activity in well-healed burn survivors. The investigators will conduct a randomized crossover design study. Non-burned control subjects and subjects who experienced burns covering 20% or more of their body surface area will be investigated. Subjects will exercise in heated environmental conditions while receiving no cooling (control) as well as skin wetting.
Within the United States, 500,000+ individuals are enduring the long-term consequences of severe burn injuries covering 20% or more of their body surface area, with upwards to 11,000 individuals experiencing such an injury per year. These burn injuries can severely compromise body temperature regulation, owing to permanent impairments in the primary thermoeffectors necessary to dissipate heat, namely profoundly blunted skin blood flow and sweating responses in the injured skin. The investigators propose that this heat intolerance deters burn survivors from participating in physical activity, including activities of daily living, necessary to avoid the adverse cardiovascular and metabolic sequela of a sedentary lifestyle. Consistent with hypothesis, years after the injury burn survivors have a very low aerobic capacity; greater all-cause mortality rates; greater hospitalization days for circulatory diseases; and suffer from greater incidences of ischemic heart disease, heart failure, diabetes, and cerebrovascular disease (including stroke) relative to matched non-burned cohorts. The primary goal of this project is to identify modalities to attenuate excessive elevations in skin and core body temperatures, and accompanying cardiovascular stress, during physical activity in well-healed burn survivors. The implementation of such modalities will eliminate heat intolerance as a barrier to participation in activities that are necessary to improve/maintain cardiovascular health in this vulnerable population. This project will investigate whether increased skin wetness will restore otherwise impaired evaporative cooling of well-healed burn survivors, with the extent of that improvement predicated on the environmental conditions and the percentage of body surface area burned.
719 studies on the registry are indexed under Burns; 145 are open to participants now.
This study's enrollment of 31 is below the median of 40 across 524 interventional studies indexed under Burns.
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Of its 135 completed or terminated interventional studies of FDA-regulated products, 100 (74%) have results posted.
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Inclusion Criteria: Non-Burned Individuals
Exclusion Criteria: Non-Burned Individuals
Inclusion Criteria: Burn Survivors
Exclusion Criteria: Burn Survivors
Non-burned individuals will exercise for 60 minutes in the heat while being exposed to either no cooling or cooling via skin wetting (two trials).
Other: Control (no cooling modalities) · Other: Water Spray
Burn survivors with 20% or more BSA (burn surface area) burn-injured will exercise for 60 in the heat while being exposed to either no cooling or cooling via skin wetting (two trials).
Other: Control (no cooling modalities) · Other: Water Spray
Subjects will exercise for 60 minutes in the heat while being exposed to no cooling modality.
Subjects will exercise for 60 minutes in the heat while being exposed to skin wetting. Skin wetting will be performed by spraying water onto the skin throughout the exercise bout.
Change in Core Temperature (°C) During Control Intervention
The subject's core body temperature will be measured from gastrointestinal or rectal temperature measures.
Time frame: At 0 minutes and 60 minutes into the intervention.
Change in Core Temperature (°C) During Water-Spray Intervention
The subject's core body temperature will be measured from gastrointestinal or rectal temperature measures.
Time frame: At 0 minutes and 60 minutes into the intervention.
Skin Temperature (°C) Following Control Intervention
The subject's skin temperature will be measured from small temperature sensitive electrodes attached to the participant's skin.
Time frame: At 60 minutes into the intervention.
Skin Temperature (°C) Following Water-Spray Intervention
The subject's skin temperature will be measured from small temperature sensitive electrodes attached to the participant's skin.
Time frame: At 60 minutes into the intervention.
Heart Rate Following Control Intervention
The subject's heart rate will be measured from ECG electrodes attached to the participant.
Time frame: At 60 minutes into the intervention.
Heart Rate Following Water-Spray Intervention
The subject's heart rate will be measured from ECG electrodes attached to the participant.
Time frame: At 60 minutes into the intervention.
Mean Arterial Blood Pressure Following Control Intervention
The subject's mean arterial blood pressure will be measured using a standard arm blood pressure cuff. Mean Arterial Pressure (MAP) is a common physiological measure calculated by adding the diastolic blood pressure value to one third of the difference between the systolic (SBP) and diastolic (DBP) blood pressure values. MAP = DBP + 1/3(SBP - DBP)
Time frame: At 60 minutes into the intervention.
Mean Arterial Blood Pressure Following Water-Spray Intervention
The subject's mean arterial blood pressure will be measured using a standard arm blood pressure cuff. Mean Arterial Pressure (MAP) is a common physiological measure calculated by adding the diastolic blood pressure value to one third of the difference between the systolic (SBP) and diastolic (DBP) blood pressure values. MAP = DBP + 1/3(SBP - DBP)
Time frame: At 60 minutes into the intervention.
Plan to share: No
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This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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University of Texas Southwestern Medical Center