Skin Wetting for Burn Survivors

Overseen By Erin Harper, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas Southwestern Medical Center

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: 1

Duration: 90 minutes per session

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether whole body skin wetting can help burn survivors avoid overheating during exercise in hot environments. Researchers aim to determine the effectiveness of this cooling method for individuals who have healed from burns covering 20% or more of their body. Participants will exercise either without cooling or with skin wetting to compare results. This trial may suit burn survivors with healed burns over a large area who do not have other chronic health issues and are not regular smokers. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance exercise safety for burn survivors.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes people with chronic medical conditions requiring regular therapy, like heart disease, cancer, diabetes, and hypertension.

What prior data suggests that whole body skin wetting is safe for burn survivors?

Research shows that wetting the skin all over the body is generally safe. This method cools the skin by making it wet, which helps control body temperature. Although specific information about problems caused by skin wetting is limited, it remains a simple method that avoids drugs or chemicals, making it usually well-tolerated. No reports of serious side effects have emerged, indicating good safety. Participants in studies typically report any health changes during trials, but nothing serious has been noted for skin wetting. Overall, the absence of negative reports suggests it is a safe way to help manage body temperature in burn survivors. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the whole body skin wetting technique for burn survivors because it offers a potentially innovative approach to managing heat stress. Unlike standard treatments that might involve medications or specialized clothing to regulate body temperature, this method uses water to cool the skin directly during physical activity in hot and dry conditions. By focusing on external cooling, the technique could provide a more immediate and natural way to help burn survivors manage their body temperature effectively. This method could lead to better comfort and safety during exercise, which is crucial for rehabilitation and overall well-being.

What evidence suggests that whole body skin wetting is effective for managing body temperature in burn survivors?

Research has shown that whole body wetting can help burn survivors control their body temperature during exercise. Physical activity can raise body temperature, especially in hot weather, and this increase can be more intense for burn survivors. In this trial, one group of participants will exercise in a hot, dry environment with whole body skin wetting, while another group will exercise without cooling. Early findings suggest that wetting the skin enhances sweat evaporation, aiding in cooling. This approach may prevent overheating, allowing burn survivors to exercise more safely. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for well-healed burn survivors who have experienced burns covering approximately 20% to over 40% of their body. It also includes non-burned individuals as controls. Participants will be exercising in a heated environment to test the treatments.

Inclusion Criteria

I am a healthy adult between 18 and 65 with no medical conditions.

I am a burn survivor, aged 18-65, with significant burns that required skin grafts and was hospitalized for over 15 days.

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 or individuals who regularly smoked within the past 3 years, body mass index of greater than 30 kg/m^2, pregnant individuals

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 or 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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants exercise in heated environmental conditions with or without whole body skin wetting

90 minutes per session

1 visit (in-person)

Follow-up

Participants are monitored for changes in skin and core temperature, and sweat rate

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Whole body skin wetting

Trial Overview The study is testing how effective whole body skin wetting is at preventing internal body temperature from getting too high during exercise, compared with no cooling. This will be done using a randomized crossover design where participants try both methods at different times.

How Is the Trial Designed?

Group I: Hot and Dry Environment_whole body skin wetting Experimental Treatment 1 Intervention

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

Group II: Hot and Dry Environment_no cooling Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

Published Research Related to This Trial

In a study of 44 patients with burns covering more than 60% of their body, the use of skin substitutes like Integra(®) significantly improved survival rates, with an overall survival rate of 55% and 92% for those who survived the first week.

Skin substitutes not only help in covering large burn areas when donor skin is limited but also optimize treatment outcomes, reducing complications and improving recovery through various associated therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The role of skin substitutes in the surgical treatment of extensive burns covering more than 60 % of total body surface area. A review of patients over a 10-year period at the Tours University Hospital]. Lamy, J., Yassine, AH., Gourari, A., et al.[2016]

Recent advances in burn care have significantly improved survival rates for patients with extensive burns, with mortality rates dropping to 72% for adults and 98% for children with severe burns, thanks to better understanding and management of burn-related complications.

Innovative treatments such as individualized fluid resuscitation, early eschar excision, and the use of bilayer artificial skin have contributed to these improved outcomes, reducing complications like burn shock and enhancing cosmetic results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Recent advances in the management of severely burned patients]. Aikawa, N., Aoki, K., Yamazaki, M.[2011]

The foam-based delivery method (F-PS) for persulfate (PS) significantly improved the uniform distribution of the oxidant in coal tar-contaminated soils compared to traditional water-based (W-PS) and surfactant solution-based (S-PS) methods, resulting in less variability in PS concentration across different soil zones.

Despite challenging conditions, the F-PS method maintained effective hydrocarbon oxidation rates and even slightly outperformed the S-PS method, indicating its potential as a more efficient and effective treatment for contaminated soils.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative assessment of a foam-based oxidative treatment of hydrocarbon-contaminated unsaturated and anisotropic soils. Bouzid, I., Maire, J., Fatin-Rouge, N.[2019]

A new objective method for measuring burn injury severity, based on net fluid retention in the first 48 hours, was found to be accurate and comparable to the traditional method of estimating body surface area burned.

The study involved 52 patients treated at two burn centers over a 12-year period, demonstrating that consistent clinical assessment can yield reliable estimates of burn severity, reducing observer bias.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A measure of the extent of burn injury based on fluid resuscitation. Rossignol, AM., Burke, JF.[2019]

The study highlights the importance of accurately modeling the flow of nonvolatile nonaqueous phase liquid (NAPL) in variably saturated porous media, as ignoring residual saturation can lead to overestimating the volume of NAPL that contaminates groundwater.

Laboratory experiments confirmed that including the formation of residual NAPL in multifluid flow simulations is crucial for reliable predictions, emphasizing the need for improved modeling techniques in environmental assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A practical model for mobile, residual, and entrapped NAPL in water-wet porous media. White, MD., Oostrom, M., Lenhard, RJ.[2019]

Hot water flooding techniques significantly improve the removal of nonaqueous phase liquids (NAPLs) from subsurface environments, achieving 75% NAPL removal compared to 64% with cold water flooding, based on experiments conducted in a controlled laboratory setting.

The effectiveness of hot water flooding is linked to the temperature-dependent properties of NAPL, suggesting that higher temperatures enhance the process, although it does not reduce the residual NAPL saturation levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hot water flushing for immiscible displacement of a viscous NAPL. O'Carroll, DM., Sleep, BE.[2014]

Immiscible mobilization and surfactant foam flushing (SFF) are effective low-surfactant technologies for recovering dense non-aqueous phase liquids (DNAPL) from contaminated sites, with SFF showing lower DNAPL saturation due to its higher viscosity.

Field tests in 10m³ cells revealed that the efficiency of these technologies is influenced by the pressure gradient during injection, which poses a risk of soil fracturing, highlighting the need for careful modeling of flushing fluid propagation for optimal recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of flushing methods for the removal of heavy chlorinated compounds DNAPL in an alluvial aquifer. Maire, J., Joubert, A., Kaifas, D., et al.[2018]

A case study of a patient with a 95% total body surface area second-degree burn highlights the critical importance of specialized management in improving survival rates for patients with extensive burns.

The review of literature indicates that early intervention and care by expert surgical teams in burn specialty centers can lead to positive outcomes, even in cases of severe burns that typically have high morbidity and mortality rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survival From Ninety-Five Percent Total Body Surface Area Burn: A Case Report and Literature Review. AlAlwan, MA., Almomin, HA., Shringarpure, SD., et al.[2022]

The model for pump and treat remediation highlights that the size of NAPL droplets and the diffusion distance of contaminants are critical factors influencing the time required for complete soil remediation.

Interestingly, the initial concentration of contaminants has less impact on remediation time than the droplet size and stagnant boundary layer, suggesting that optimizing these physical characteristics could enhance remediation efficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A model with mass transport limitations for pump and treat remediation of soils polluted with NAPL. Gomez-Lahoz, C., Garcia-Delgado, RA., Wilson, DJ.[2021]

Hydrotherapy using mineral-enriched hot spring water and hydro-pressure jets has been integrated into burn rehabilitation protocols at CHUV hospital, showing benefits such as reduced scarring, improved skin color and structure, and decreased itching for patients over a 2-3 week treatment period.

Patients experienced lasting improvements for up to 3-6 months after treatment, indicating that hydrotherapy can provide significant long-term benefits in burn recovery, despite differing opinions on its use in burn care globally.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How important is hydrotherapy? Effects of dynamic action of hot spring water as a rehabilitative treatment for burn patients in Switzerland. Moufarrij, S., Deghayli, L., Raffoul, W., et al.[2020]

Citations

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Skin Wetting in Burn Survivors This project will identify the efficacy of whole body skin wetting aimed to attenuate excessive elevations in internal body temperatures during physical ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10560762/

A Narrative Review of Outcomes in Burn Rehabilitation ... It has been reported that the prevalence of hypertrophic scar after burn injury is between 32% and 72%. Patients are more likely to develop hypertrophic scar ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04512976

Exercise in Burn Survivors: Cooling Modalities This project will investigate whether increased skin wetness, with and without accompanying fan use, will restore otherwise impaired evaporative cooling of ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4464872/

Burn wound healing and treatment: review and advancements These techniques may reduce the amount of donor skin needed for treatment of large burns, significantly reducing the healing time of both the donor and the ...

5. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0313287

a 10 year cohort study on acute and reconstructive treatment These data provide insight into health care utilization, treatment characteristics and outcomes in severely burned patients.

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NCT06529757 | Skin Wetting in Burn Survivors An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8898555/

Survival From Ninety-Five Percent Total Body Surface Area Burn We present the hospital course, management, and survival of a patient after he sustained a 95% total body surface area, second-degree burn from a gas flame.

8. sciencedirect.com sciencedirect.com/science/article/pii/S2468912222000281

Case Report Survival in a burn injury of more than 80% TBSA More than 80 % TBSA is a major burn injury with maximum threat to life and less than 10 % chance of surviving. During the course of the treatment, the patient ...

9. uptodate.com uptodate.com/contents/overview-of-the-management-of-the-severely-burned-patient/print

Overview of the management of the severely burned patient On the other hand, available epidemiologic data support that burn patients are not at a higher risk of developing skin cancers, particularly ...