What side effects are associated with this type of intervention?

Common treatments for frostbite, such as rewarming the affected area in warm water, can cause side effects including pain during the rewarming process, swelling, and potential tissue damage if the water temperature is not precisely controlled. There is also a risk of infection and long-term complications like nerve damage or loss of function in the affected area.

What prior FDA approvals exist?

The provided context does not mention specific FDA approvals or related drugs for the treatment of frostbite. Generally, frostbite treatment focuses on rapid rewarming, wound care, and sometimes medications to improve blood flow and reduce clotting. The use of sous vide devices for precise and consistent heating of water for rewarming is a novel approach being studied, but specific FDA approvals for this method are not detailed in the context.

What other types of research exist?

Promising alternatives to sous vide devices for frostbite treatment in 2024 include advanced medical-grade warming devices, portable and programmable water baths, and innovative rewarming techniques such as phase change materials or conductive heating pads.

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Other

Sous Vide Therapy for Frostbite

Q: What is the mechanism of action of this treatment?

The most common treatments for frostbite involve rapid rewarming of the affected tissues, typically using a warm water bath maintained at a precise temperature (37-39°C or 98.6-102.2°F). This method works by restoring blood flow and preventing further tissue damage. The use of sous vide devices for rewarming is particularly relevant as they provide precise and consistent heating, which is crucial for minimizing tissue damage and improving outcomes. Accurate temperature control helps prevent the complications associated with uneven or excessive heating, such as additional tissue injury or burns, making it a critical aspect of effective frostbite management.

N/A

Recruiting

Led By Nicholas Daniel, DO

Research Sponsored by Dartmouth-Hitchcock Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Acute frostbite of the hands and/or feet

Age <17 with parent or guardian consent

Must not have

Frostbite of tissue other than hands or feet

Frostbite that has already thawed

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 90 minutes

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing sous vide devices to help rewarm patients with frostbite. These devices can keep water at a precise temperature, which is important for safely treating frostbite. The study aims to see if this method is safe and effective. Sous vide devices have been used in clinical settings to create and maintain a circulating warm water bath for rewarming frostbitten extremities.

Who is the study for?

This trial is for English-speaking adults with acute frostbite on their hands or feet. Minors can join if they have a parent or guardian's consent. It's not for those who cannot consent, don't understand English, have already thawed frostbite, or have frostbite on other body parts.

What is being tested?

The study tests the effectiveness of sous vide devices in rewarming and maintaining warm water circulation for treating acute frostbite. Participants will use these devices to see how well they help heal affected areas.

What are the potential side effects?

Potential side effects may include discomfort during treatment, possible burns from incorrect temperature settings, skin irritation from prolonged exposure to moisture, and infection risk due to improper device use.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have recent frostbite on my hands or feet.

Select...

I am under 17 and have my parent or guardian's consent.

Select...

I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have had frostbite on parts of my body other than my hands or feet.

Select...

I have had frostbite, but it has already thawed.

Select...

I am under 18 and do not have a parent or guardian.

Select...

I am unable to give consent by myself.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 90 minutes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 90 minutes

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 90 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Rewarming

Time to rewarm in minutes

Secondary study objectives

Ease of Use: Provider review

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Sous vide deviceExperimental Treatment1 Intervention

The intervention will be the use of a sous vide device to heat the water bath to 38 degrees celsius, rather than the traditional methods of manual water exchanges or placing the frostbitten tissue under running water.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sous Vide Device (SVD)

2021

N/A

~10

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for frostbite involve rapid rewarming of the affected tissues, typically using a warm water bath maintained at a precise temperature (37-39°C or 98.6-102.2°F). This method works by restoring blood flow and preventing further tissue damage. The use of sous vide devices for rewarming is particularly relevant as they provide precise and consistent heating, which is crucial for minimizing tissue damage and improving outcomes. Accurate temperature control helps prevent the complications associated with uneven or excessive heating, such as additional tissue injury or burns, making it a critical aspect of effective frostbite management.

Whole- and partial-body cryostimulation/cryotherapy: Current technologies and practical applications.Analgesics, sedatives, anticonvulsant drugs, and the cooled brain.