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NCT Number: NCT06529757

Skin Wetting in Burn Survivors

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.

Recruiting

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Key information

Conditions

Burn Injury Burns Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Whole body cooling

Other

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

Other

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

Primary outcomes

  1. Core Temperature

    Time frame: Prior to and throughout the bout of exercise; an average of 90 minutes.

    During exercise, one's core body temperature will increase. This device will measure this increase in core body temperature throughout the exercise.

Secondary outcomes

  1. Mean Skin Temperature

    Time frame: Prior to and throughout the bout of exercise; an average of 90 minutes.

    Average skin temperature from six sites.

  2. Rate Pressure Product

    Time frame: Prior to and throughout the bout of exercise; an average of 90 minutes.

    Obtained from heart rate and systolic blood pressure.

  3. Whole body sweat rate

    Time frame: Before and after exercise. 2 min per measure.

    Whole body sweat rate will be measured from pre and post nude body mass measures.

Study contacts

Contact information is provided by the study sponsor or research team.

Craig Crandall, PhD

CONTACT

[email protected]

214-345-4623

Erin Harper, BS

CONTACT

[email protected]

214-345-4737

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 31, 2024
Registry last updated
Oct 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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