[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06529757":3,"trial-entities:NCT06529757":107,"trial-summary:NCT06529757":111},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":38,"secondary_outcomes":43,"sex":54,"minimum_age":55,"maximum_age":56,"healthy_volunteers":57,"eligibility_criteria":58,"std_ages":75,"locations":78,"central_contacts":98,"overall_officials":104,"references":105,"see_also_links":106},"NCT06529757","STU_2020_0334_B","Skin Wetting in Burn Survivors","RECRUITING","2026-07-31","2025-10","2025-10-21","2024-07-31","University of Texas Southwestern Medical Center","OTHER",false,"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.",null,[18],"Burn Injury",[],"INTERVENTIONAL","PREVENTION",[23],"NA",{"count":25,"type":26},40,"ESTIMATED",[28,33],{"type":13,"name":29,"description":30,"armGroupLabels":31},"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.",[32],"Hot and Dry Environment_whole body skin wetting",{"type":13,"name":34,"description":35,"armGroupLabels":36},"Non-cooling","Subjects will exercise for 60 minutes in the indicated environmental condition while being exposed to no cooling modalities.",[37],"Hot and Dry Environment_no cooling",[39],{"measure":40,"description":41,"timeFrame":42},"Core Temperature","During exercise, one's core body temperature will increase. This device will measure this increase in core body temperature throughout the exercise.","Prior to and throughout the bout of exercise; an average of 90 minutes.",[44,47,50],{"measure":45,"description":46,"timeFrame":42},"Mean Skin Temperature","Average skin temperature from six sites.",{"measure":48,"description":49,"timeFrame":42},"Rate Pressure Product","Obtained from heart rate and systolic blood pressure.",{"measure":51,"description":52,"timeFrame":53},"Whole body sweat rate","Whole body sweat rate will be measured from pre and post nude body mass measures.","Before and after exercise. 2 min per measure.","ALL","18 Years","65 Years",true,{"inclusion":59,"exclusion":65,"raw_text":74},[60,61,62,60,61,62,63,64],"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",[66,67,68,69,70,71,72,66,67,68,69,70,71,72,73],"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\u002Fm\\^2.","Pregnant individuals","Extensive unhealed injured skin","Inclusion Criteria: Non-burn survivors\n\n* Healthy male and female subjects\n* 18-65 years of age.\n* Free of any underlying medical conditions\n\nExclusion Criteria (non-burned individuals):\n\n* Any burn-related injuries resulting in at least one night of hospitalization.\n* Heart disease or any other chronic medical condition requiring regular medical therapy including cancer, diabetes, and hypertension.\n* Abnormalities detected on routine screening\n* Individuals who participate in a structured aerobic exercise training program at moderate to high intensities.\n* Current smokers, as well as individuals who regularly smoked within the past 3 years.\n* Body mass index of greater than 30 kg\u002Fm\\^2.\n* Pregnant individuals\n\nInclusion Criteria (burn survivors):\n\n* Healthy male and female subjects\n* 18-65 years of age.\n* Free of any underlying medical conditions\n* 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.\n* Participants must have been hospitalized due to the burn injury for a minimum of 15 days\n\nExclusion Criteria (burn survivors):\n\n* Any burn-related injuries resulting in at least one night of hospitalization.\n* Heart disease or any other chronic medical condition requiring regular medical therapy including cancer, diabetes, and hypertension.\n* Abnormalities detected on routine screening\n* Individuals who participate in a structured aerobic exercise training program at moderate to high intensities.\n* Current smokers, as well as individuals who regularly smoked within the past 3 years.\n* Body mass index of greater than 30 kg\u002Fm\\^2.\n* Pregnant individuals\n* Extensive unhealed injured skin",[76,77],"ADULT","OLDER_ADULT",[79],{"facility":80,"status":7,"city":81,"state":82,"zip":83,"country":84,"contacts":85,"geoPoint":95},"Institute for Exercise and Environmental Medicine","Dallas","Texas","75231","United States",[86,91],{"name":87,"role":88,"phone":89,"email":90},"Craig Crandall, PhD","CONTACT","214-345-4623","craigcrandall@texashealth.org",{"name":92,"role":88,"phone":93,"email":94},"Taysom Wallace, MS","214-345-5022","taysomwallace@texashealth.org",{"lat":96,"lon":97},32.78306,-96.80667,[99,100],{"name":87,"role":88,"phone":89,"email":90},{"name":101,"role":88,"phone":102,"email":103},"Erin Harper, BS","214-345-4737","ErinHarper@texashealth.org",[],[],[],{"nct_id":4,"conditions":108,"biomarkers":110},[109],"Burn",[],{"nct_id":4,"found":57,"summary":112,"prompt_version":122},{"design":113,"status":114,"heading":115,"summary":116,"follow_up":117,"word_count":118,"commitments":119,"compensation":120,"drugs_mentioned":121},"This is an interventional study with a randomized crossover design, meaning participants will experience both cooling and non-cooling conditions. It plans to enroll 40 participants.","completed","Skin Wetting in Burn Survivors Study","This study is looking at how whole body skin wetting can help burn survivors stay cool during exercise. Researchers want to see if spraying water on the body can prevent internal body temperatures from getting too high during physical activity. The study will compare whole body cooling (spraying water) with no cooling during exercise in heated conditions. They will measure your core temperature to see how well the cooling works. This study is for healthy individuals aged 18 to 65 years old who have not had burn injuries requiring hospitalization. The study plans to enroll 40 participants, but its current status is unclear.","Core temperature will be measured prior to and throughout the exercise bout, for an average of 90 minutes.",103,"You would exercise for 60 minutes in a heated environment, sometimes with water sprayed on your body and sometimes without. Your core temperature will be measured before and throughout the exercise session, for an average of 90 minutes.","Not stated in the trial record.",[29],"v2"]