Skin Wetting for Burn Survivors

Overseen By Taysom Wallace, MS

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

Trial Summary

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 data supports the effectiveness of the treatment Whole body skin wetting for burn survivors?

The research on hydrotherapy, which involves water treatments, shows benefits for burn patients, such as improved skin structure and reduced scarring. This suggests that similar water-based treatments like whole body skin wetting could also help in burn rehabilitation. ^{1 2 3 4 5}

What makes whole body skin wetting treatment unique for burn survivors?

Whole body skin wetting is a novel treatment for burn survivors that involves applying water to the entire body, which may help in maintaining skin hydration and promoting healing. Unlike traditional treatments that might focus on topical ointments or dressings, this method emphasizes the use of water to support the skin's natural recovery process. ^{6 7 8 9 10}

What is the purpose of this trial?

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.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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]

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]

References

1. Italy 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. [2020]

2. England pubmed.ncbi.nlm.nih.gov

A measure of the extent of burn injury based on fluid resuscitation. [2019]

3. France 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]. [2016]

4. Japan pubmed.ncbi.nlm.nih.gov

[Recent advances in the management of severely burned patients]. [2011]

5. United States pubmed.ncbi.nlm.nih.gov

Survival From Ninety-Five Percent Total Body Surface Area Burn: A Case Report and Literature Review. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

A practical model for mobile, residual, and entrapped NAPL in water-wet porous media. [2019]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Hot water flushing for immiscible displacement of a viscous NAPL. [2014]

8. Netherlands pubmed.ncbi.nlm.nih.gov

A model with mass transport limitations for pump and treat remediation of soils polluted with NAPL. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Comparative assessment of a foam-based oxidative treatment of hydrocarbon-contaminated unsaturated and anisotropic soils. [2019]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Assessment of flushing methods for the removal of heavy chlorinated compounds DNAPL in an alluvial aquifer. [2018]