Multicenter Sous Vide Frostbite

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.

Detailed Description
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Frostbite can be a devastating and limb threatening injury. Treatment involves active rewarming in a warm water bath at a consistent temperature, but maintaining the correct temperature water is clinically challenging. Currently these water baths are created and monitored manually - leading to poor rewarming and inefficient use of resources. The sous vide device offers an alternative to the manual water bath method. The specific aim of our study is to evaluate the safety, efficacy, and feasibility of use of the sous vide device in patients with extremity frostbite in a multicenter prospective cohort. Data demonstrating the ability of the sous vide device to warm and precisely maintain water bath target temperatures, in addition to expanded evidence of the safety of this modality, will support the broader use of sous vide devices in frostbite care.

Official Title
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Assessment of Sous Vide Water Baths for 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 and/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 38 degrees celsius, 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 and the SVD every 2 minutes. At the end of the 30 minute treatment, 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 |
| --- | --- | --- |
| Rewarming | Assess if frostbitten extremities can be thawed in a warm water bath created by the experimental device. | Up to 90 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 | Providers will report ease of use of the rewarming modality by completing a survey. The survey consists of two questions requesting providers to indicate ease of use of the device on a scale from 1-10, where 0 indicates easy and 10 indicated difficult. | Immediately after rewarming, up to 90 minutes |