Simulated Burn Injury for Burns

(HSR Trial)

Overseen By Erin M Harper, B.S.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas Southwestern Medical Center

Must not be taking: Beta blockers, Calcium channel blockers

Disqualifiers: Heart disease, Cancer, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how burn survivors recover their body temperature after exercising in the heat, compared to those without burns. Researchers use a special material to simulate burn injuries and test participants in both hot and dry, as well as hot and humid conditions. They aim to determine if the simulated burns affect how quickly the body cools down after exercise. Healthy individuals who do not take medications affecting body temperature and do not smoke might be suitable for this trial. As an unphased trial, this study offers participants the opportunity to contribute to important research that could enhance care for burn survivors.

Will I have to stop taking my current medications?

If you are taking medications that affect how your body controls temperature, like certain heart medications, you may not be able to participate in the trial. The protocol doesn't specify stopping other medications, but it's best to discuss your specific situation with the trial team.

What prior data suggests that this simulated burn injury is safe?

Previous studies have shown that simulated burn injuries affect body temperature. Research indicates that burns covering 20% to 60% of the body can increase core temperature during exercise, particularly in hot and dry conditions. This increase means individuals may feel hotter than usual during physical activity. However, even with a 40% simulated burn, individuals managed their body heat during moderate exercise in hot environments.

Similar results appeared in hot and humid conditions. Individuals with a simulated burn could exercise without overheating in mild to moderate conditions. However, more intense exercise could make it harder to stay cool. These studies reported no major safety concerns, but monitoring body temperature remains important to avoid overheating. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how different environmental conditions affect the body's response to simulated burn injuries. Unlike traditional studies that focus solely on treatment outcomes, this trial aims to understand the physiological changes that occur when burns happen in hot and dry versus hot and humid environments. Insights gained from this research could lead to better-targeted treatments and strategies for managing burn injuries in diverse climates, potentially improving patient outcomes in real-world scenarios.

What evidence suggests that this trial's simulated burn injury treatments could be effective for thermoregulation in burn survivors?

Research has shown that burn survivors often struggle to control their body temperature after exercising. This occurs because grafted skin areas do not cool down effectively, resulting in higher body temperatures in hot weather compared to those without burns. In this trial, participants will face different conditions to study this effect. Some will experience hot and dry conditions with a simulated burn injury, while others will be in hot and humid conditions with a simulated burn injury. Additional groups will be exposed to hot and dry or hot and humid conditions without simulated burns. This setup helps researchers understand how the body cools down after exercise when burns are simulated. Although direct evidence on the effectiveness of these simulated burn treatments is lacking, understanding the body's response can aid in improving care for burn survivors. ^{3 6 7 8 9}

Who Is on the Research Team?

Craig G Crandall, PhD

Principal Investigator

University of Texas Southwestern Medical Center

Are You a Good Fit for This Trial?

This trial is for individuals who are interested in understanding how simulated burn injuries affect the body's ability to cool down after exercise. Participants should be healthy, without actual burns, and willing to have material applied over a large part of their body to simulate a burn injury.

Inclusion Criteria

I have no major health issues and my heart test is normal.

I am between 18 and 65 years old.

Exclusion Criteria

I am taking medication that affects my body's temperature regulation.

Individuals who are pregnant, planning to become pregnant, or breastfeeding will be excluded, this will be confirmed in females using a urine pregnancy test

Body mass index is ≥ 31 kg/m2.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Exercise and Recovery

Participants undergo exercise in hot environments with and without simulated burn injuries to assess thermoregulation and recovery

1-2 weeks

Follow-up

Participants are monitored for safety and effectiveness after exercise sessions

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Simulated Burn Injury

Trial Overview The study tests how 'simulated' burn injuries impact post-exercise recovery in hot conditions. It involves applying special materials over 60% of the participant's body to mimic deep partial thickness burns and then measuring temperature recovery.

How Is the Trial Designed?

Group I: Hot and Humid with simulated burns Experimental Treatment 1 Intervention

Individuals will be exposed to hot and humid conditions with a simulated burn injury.

Group II: Hot and Dry with simulated burns Experimental Treatment 1 Intervention

Individuals will be exposed to hot and dry conditions with a simulated burn injury.

Group III: Hot and Humid without simulated burns Active Control 1 Intervention

Individuals will be exposed to hot and humid conditions without a simulated burn injury.

Group IV: Hot and Dry without simulated burns Active Control 1 Intervention

Individuals will be exposed to hot and dry conditions without a simulated burn injury.

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

National Institute of General Medical Sciences (NIGMS)

Collaborator

Trials

315

Recruited

251,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9676699/

Effect of Virtual Reality-Based Interventions on Pain During ... This systematic review and meta-analysis aimed to examine the effect of virtual reality (VR)-based interventions on pain during wound care in burn patients.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0003999322005937

Use of Virtual Reality in Burn Rehabilitation: A Systematic ... VR-based burn rehabilitation significantly improves the QOL and work performance of burn patients, significantly increases the ROM gain of the tested joints.

3. academic.oup.com academic.oup.com/jbcr/article/46/1/154/7673494

Systematic Review of Simulation in Burn Care These simulations should encompass major categories of burn management, including burn wound assessment, burn critical care, acute and early ...

4. frontiersin.org frontiersin.org/journals/virtual-reality/articles/10.3389/frvir.2025.1651695/full

Efficacy of virtual reality in pediatric burn patients Outcomes: Studies must report data on primary outcome: pain intensity. Studies reporting data on any secondary outcome were also included ...

5. nature.com nature.com/articles/s41598-017-11390-y

Quantifying the efficacy of first aid treatments for burn ... We quantify the efficacy of first aid treatments using a mathematical model to describe data from a series of in vivo porcine experiments.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7024026/

Exercise Thermoregulation with a Simulated Burn Injury Simulated burn injuries of 20%, 40%, and 60% of total body surface area led to significantly elevated core temperature in 40°C vs. 25°C conditions, and greater ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7995740/

Interaction of Exercise Intensity and Simulated Burn Injury ... A larger simulated burn (i.e., 40% + BSA burned) resulted in greater increases in TGI during more intense exercise in hot and dry environmental conditions.

8. apps.dtic.mil apps.dtic.mil/sti/trecms/pdf/AD1169473.pdf

Effects of Burn Injuries on Thermoregulatory and ... - DTIC Interpretation B: In summary, an approximate 20% TBSA simulated torso burn injury does not exacerbate thermoregulatory strain during exercise in a hot-dry ...

9. researchgate.net researchgate.net/publication/336446802_Exercise_Thermoregulation_with_a_Simulated_Burn_Injury_Impact_of_Air_Temperature

Exercise Thermoregulation with a Simulated Burn Injury Results: In 40°C conditions, greater elevations in core temperature were observed with 40% and 60% TBSA simulated burn injuries vs. Control (P < 0.01). However, ...