Skin Wetting in Burn Survivors

Not Applicable

Recruiting

• Conditions: Burn Injury

• Registration Number: NCT06529757
• Lead Sponsor: University of Texas Southwestern Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-26
• Study First Submitted QC: 2024-07-26
• Study Start: 2024-07-31
• Study First Posted: 2024-07-31
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-15
• Last Update Posted: 2025-08-21
• Primary Completion: 2026-07-31
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Core Temperature	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 Outcome Measures

Name	Time	Method
Mean Skin Temperature	Prior to and throughout the bout of exercise; an average of 90 minutes.	Average skin temperature from six sites.
Rate Pressure Product	Prior to and throughout the bout of exercise; an average of 90 minutes.	Obtained from heart rate and systolic blood pressure.
Whole body sweat rate	Before and after exercise. 2 min per measure.	Whole body sweat rate will be measured from pre and post nude body mass measures.

Trial Locations

Locations (1)

Institute for Exercise and Environmental Medicine; 🇺🇸 Dallas, Texas, United States