Recruiting

Observational Study

Sponsor:

University of Texas Southwestern Medical Center

Code:

NCT06529757

Conditions

Burn Injury

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Whole body cooling

Non-cooling

Study Details

Brief summary:

This project will identify the efficacy of whole body skin wetting aimed to attenuate excessive elevations in internal body temperatures during physical activity in well-healed burn survivors. The investigators will conduct a randomized crossover design study. Non-burned control subjects, subjects who experienced burns covering \~20% to 40% of their body surface area, and subject having burns >40% of their body surface area will be investigated. Subjects will exercise in heated environmental conditions while receiving no cooling or whole body skin wetting.

Conditions

Burn Injury

Study ID

NCT06529757

Start date

Jul 31, 2024

Status verified date

Oct, 2025

Completion date

Jul 31, 2026

Anticipated

Primary completion date

Jul 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Inclusion Criteria: Non-burn survivors

  • Healthy male and female subjects
  • 18-65 years of age.
  • Free of any underlying medical conditions

Exclusion Criteria (non-burned individuals):

  • Any burn-related injuries resulting in at least one night of hospitalization.
  • Heart disease or any other chronic medical condition requiring regular medical therapy including cancer, diabetes, and hypertension.
  • Abnormalities detected on routine screening
  • Individuals who participate in a structured aerobic exercise training program at moderate to high intensities.
  • Current smokers, as well as individuals who regularly smoked within the past 3 years.
  • Body mass index of greater than 30 kg/m\^2.
  • Pregnant individuals

Inclusion Criteria (burn survivors):

  • Healthy male and female subjects
  • 18-65 years of age.
  • Free of any underlying medical conditions
  • Having a burn injury covering 20-40% or >40% of the participant's body surface area; at least 50% of those burn injuries must be full thickness that required skin grafting.
  • Participants must have been hospitalized due to the burn injury for a minimum of 15 days

Exclusion Criteria (burn survivors):

  • Any burn-related injuries resulting in at least one night of hospitalization.
  • Heart disease or any other chronic medical condition requiring regular medical therapy including cancer, diabetes, and hypertension.
  • Abnormalities detected on routine screening
  • Individuals who participate in a structured aerobic exercise training program at moderate to high intensities.
  • Current smokers, as well as individuals who regularly smoked within the past 3 years.
  • Body mass index of greater than 30 kg/m\^2.
  • Pregnant individuals
  • Extensive unhealed injured skin

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Hot and Dry Environment no cooling

Subjects will exercise for 60 minutes in a hot and dry environment while being exposed to no cooling.

experimental: Hot and Dry Environment whole body skin wetting

Subjects will exercise for 60 minutes in a hot and dry environment while being exposed to whole body skin wetting.

Interventions

Whole body cooling

Subjects will exercise for 60 minutes in the indicated environmental condition while being exposed to whole body skin wetting. Skin wetting will be performed by spraying water onto the whole body throughout the exercise bout.

Non-cooling

Subjects will exercise for 60 minutes in the indicated environmental condition while being exposed to no cooling modalities.

Primary outcome measure

  • Core Temperature [ Time Frame: Prior to and throughout the bout of exercise; an average of 90 minutes. ]

Central Contacts and Locations

Central contacts

Craig Crandall, PhD

214-345-4623craigcrandall@texashealth.org

Erin Harper, BS

214-345-4737ErinHarper@texashealth.org

Locations

Institute for Exercise and Environmental Medicine

Recruiting

Dallas, Texas, United States, 75231

Contacts

Craig Crandall, PhD

214-345-4623craigcrandall@texashealth.org

Taysom Wallace, MS

214-345-5022taysomwallace@texashealth.org

More Information

Sponsor

University of Texas Southwestern Medical Center

Last update posted

Oct 21, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Texas Southwestern Medical Center on 2025-10-21.