Skin Wetting in Burn Survivors

NCT ID: NCT06529757

Last Updated: 2025-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-31

Study Completion Date

2026-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Burn Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Hot and Dry Environment_no cooling

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

Group Type EXPERIMENTAL

Non-cooling

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

Whole body cooling

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Non-cooling

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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


* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Texas Southwestern Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Craig Crandall

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Institute for Exercise and Environmental Medicine

Dallas, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Craig Crandall, PhD

Role: CONTACT

214-345-4623

Erin Harper, BS

Role: CONTACT

214-345-4737

Facility Contacts

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Craig Crandall, PhD

Role: primary

214-345-4623

Taysom Wallace, MS

Role: backup

214-345-5022

Other Identifiers

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STU_2020_0334_B

Identifier Type: -

Identifier Source: org_study_id

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