Skin Wetting in Burn Survivors

The University of Texas System (UT)

Status: Enrolling

Conditions: Burn Injury

Treatments: Other: Non-cooling; Other: Whole body cooling

Study type: Interventional

Funder types: Other

Identifiers

NCT06529757

STU_2020_0334_B

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Hot and Dry Environment_no cooling

Experimental group

Description:

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

Treatment:

Other: Non-cooling

Hot and Dry Environment_whole body skin wetting

Experimental group

Description:

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

Treatment:

Other: Whole body cooling