Burn InjuryNCT06529757
Skin Wetting in Burn Survivors
A study testing Whole body cooling and Non-cooling in people with Burn Injury, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Burn Injury
- What is being tested?
- Whole body cooling and Non-cooling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jul 2024to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male and female subjects
- 18-65 years of age.
- Free of any underlying medical conditions
- 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
Who cannot join
- 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.
Show all 15Show fewer
- Pregnant 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
- Extensive unhealed injured skin
Trial locations and contacts
1 site in 1 country.
United States1 site
Institute for Exercise and Environmental Medicine
Dallas, Texas, 75231
About this study
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
- Being tested
- Whole body cooling, Non-cooling
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole body coolingOther
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-coolingOther
Subjects will exercise for 60 minutes in the indicated environmental condition while being exposed to no cooling modalities.
| Study group | Role | What they receive |
|---|---|---|
| Hot and Dry Environment_no cooling | Experimental | Subjects will exercise for 60 minutes in a hot and dry environment while being exposed to no cooling. Receives: Other: Non-cooling |
| Hot and Dry Environment_whole body skin wetting | Experimental | Subjects will exercise for 60 minutes in a hot and dry environment while being exposed to whole body skin wetting. Receives: Other: Whole body cooling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Core Temperature
During exercise, one's core body temperature will increase. This device will measure this increase in core body temperature throughout the exercise.
Measured: Prior to and throughout the bout of exercise; an average of 90 minutes.
Secondary outcomes (3)
Mean Skin Temperature
Average skin temperature from six sites.
Measured: Prior to and throughout the bout of exercise; an average of 90 minutes.
Rate Pressure Product
Obtained from heart rate and systolic blood pressure.
Measured: Prior to and throughout the bout of exercise; an average of 90 minutes.
Whole body sweat rate
Whole body sweat rate will be measured from pre and post nude body mass measures.
Measured: Before and after exercise. 2 min per measure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start31 Jul 2024
- Primary completion31 Jul 2026
- Study completion31 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burn InjuryStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Craig Crandall, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06529757
- Sponsor's protocol ID
- STU_2020_0334_B
- Status last verified
- Oct 2026
- First submitted
- 26 Jul 2024
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skin Wetting in Burn Survivors
- ClinicalTrials.gov ID
- NCT06529757
- Acronym / sponsor ID
- STU_2020_0334_B
- Conditions
- Burn Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 31 Jul 2024 (actual)
- Primary completion
- 31 Jul 2026 (actual)
- Study completion
- 31 Jul 2026 (actual)
- First posted
- 31 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hot and Dry Environment_no cooling | Experimental | Other: Non-coolingSubjects will exercise for 60 minutes in a hot and dry environment while being exposed to no cooling. |
| Hot and Dry Environment_whole body skin wetting | Experimental | Other: Whole body coolingSubjects will exercise for 60 minutes in a hot and dry environment while being exposed to whole body skin wetting. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Healthy male and female subjects
- 18-65 years of age.
- Free of any underlying medical conditions
- Healthy male and female subjects
- 18-65 years of age.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole body coolingSubjects 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. | Other | Hot and Dry Environment_whole body skin wetting |
| Non-coolingSubjects will exercise for 60 minutes in the indicated environmental condition while being exposed to no cooling modalities. | Other | Hot and Dry Environment_no cooling |
Primary outcome
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.
3 secondary outcomes
Mean Skin Temperature
Time frame: Prior to and throughout the bout of exercise; an average of 90 minutes.
Rate Pressure Product
Time frame: Prior to and throughout the bout of exercise; an average of 90 minutes.
Whole body sweat rate
Time frame: Before and after exercise. 2 min per measure.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole body cooling and Non-cooling in people with Burn Injury, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Core Temperature (time frame: Prior to and throughout the bout of exercise; an average of 90 minutes.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.