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Recruiting NCT06529757

Skin Wetting in Burn Survivors

No phase Interventional Burn Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Whole body cooling, Non-cooling.
Who it may be relevant to
Registry conditions: Burn Injury. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

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

Primary outcome measures

  • Core Temperature [Time frame: Prior to and throughout the bout of exercise; an average of 90 minutes.]
Secondary outcome measures (3)
  • 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.]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • Institute for Exercise and Environmental Medicine — Dallas

Identifiers

NCT: NCT06529757 · STU_2020_0334_B

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗