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RecruitingNCT06529757Updated Oct 21, 2025

Skin Wetting in Burn Survivors

An interventional study of Whole body cooling and Non-cooling in Burn Injury, sponsored by University of Texas Southwestern Medical Center. Recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-10-21.

Sponsored by University of Texas Southwestern Medical Center · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Started Jul 2024; still recruiting 2 years 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Burn Injury

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03

In context

Burns

719 studies on the registry are indexed under Burns; 145 are open to participants now.

This study's planned enrollment of 40 is close to the median of 40 across 524 interventional studies indexed under Burns.

Browse Burns studies →

Lead sponsor

University of Texas Southwestern Medical Center is the lead sponsor of 990 studies on the registry; 201 are open to participants now.

Of its 135 completed or terminated interventional studies of FDA-regulated products, 100 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study 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.

    Other: Non-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.

    Other: Whole body cooling

Interventions

  • OtherWhole 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.

  • OtherNon-cooling

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

06

What researchers measure

Primary outcomes

  1. Core Temperature

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

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

Secondary outcomes

  1. Mean Skin Temperature

    Average skin temperature from six sites.

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

  2. Rate Pressure Product

    Obtained from heart rate and systolic blood pressure.

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

  3. Whole body sweat rate

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

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

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 21, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06529757
Lead sponsor
University of Texas Southwestern Medical Center
Responsible party
Craig Crandall (Professor, University of Texas Southwestern Medical Center) — Principal investigator
First posted
Jul 31, 2024
Start date
Jul 31, 2024
Primary completion
Jul 31, 2026 (estimated)
Completion
Jul 31, 2026 (estimated)
Last update
Oct 21, 2025

Study contacts

Craig Crandall, PhD
Contact
craigcrandall@texashealth.org
214-345-4623
Erin Harper, BS
Contact
ErinHarper@texashealth.org
214-345-4737

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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