Sous Vide Rewarming for Frostbitten Extremities

Study Overview
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Brief Summary
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The purpose of this study is to determine the efficacy of using sous vide devices for heating and maintaining the circulating warm water bath used in the rewarming of acute frostbite.

Official Title
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Clinical Utilization of Sous Vide Cooking Devices in the Acute Rewarming of Frostbitten Extremities

Conditions
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Frostbite, Frostbite of Hand, Frostbite of Foot

Intervention / Treatment
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* Device: Sous Vide Device (SVD)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 or up Age <17 with parent or guardian consent Ability to understand English Ability to provide consent to the study Acute frostbite of the hands or feet Exclusion Criteria: Children under age 18 without parent or guardian Frostbite that has already thawed Frostbite of tissue other than hands or feet Inability to understand English Inability to provide consent
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sous vide device<br>The intervention will be the use of a sous vide device to heat the water bath to 38oC, rather than the traditional methods of manual water exchanges or placing the frostbitten tissue under running water. | Device: Sous Vide Device (SVD)<br>* A basin will be filled to the marked line with water from jugs at room temperature, for each frozen extremity. The sous vide device (SVD) will be attached to the distal edge of the basin. The SVD will be turned on and set to maintain the bath at a constant 38 degrees celsius for 30 minutes duration. The thermometers will be powered on continuously and the researcher will record temperatures simultaneously from each thermometer every 2 minutes. At the end of the 30 minute treatment, the SVD will be powered off and the extremity assessed by the researcher for warmth and pliability. If the extremity still feels cold or frozen, an additional 30 minutes in the water bath will commence, with subsequent reassessment. Rewarming will be considered complete when the affected tissue becomes red or purple, soft, and pliable.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Limbs That Can be Rewarming Within 30 Minutes | Assess if frostbitten extremities can be rewarmed in 30 minutes at 38 degrees celsius using the experimental device | 30 minutes | 
| Time to Rewarm in Minutes | Measure the time required to rewarm frostbitten extremities until the extremity is reddish or purple in coloration, and soft and pliable | Up to 90 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ease of Use: Provider Review of the Investigational Device and Standard of Care | Providers will report ease of use of the rewarming modalities by completing a survey. The survey consists of two questions requesting providers to indicate ease of use of 1) the device and 2) Standard of care (manual water bath) on a scale from 1-10, where 1 indicates easy and 10 indicated difficult. | Immediately after rewarming, up to 90 minutes |