Multicenter Sous Vide Frostbite

Assessment of Sous Vide Water Baths for Acute Rewarming of Frostbitten Extremities

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.

Study Overview

• Status: Completed
• Conditions: Frostbite; Frostbite of Hand; Frostbite of Foot
• Intervention / Treatment: Device: Sous Vide Device (SVD)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth-Hitchcock Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Sous vide device; 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); 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.

What is the study measuring?

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 0-10, where 0 indicates easy and 10 indicated difficult.	Immediately after rewarming, up to 90 minutes

Collaborators and Investigators

• Sponsor: Dartmouth-Hitchcock Medical Center
• Investigators: Principal Investigator: Nicholas Daniel, DO, Dartmouth-Hitchcock Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Actual): November 25, 2024
• Study Completion (Actual): November 25, 2024

Study Registration Dates

• First Submitted: March 2, 2022
• First Submitted That Met QC Criteria: March 12, 2022
• First Posted (Actual): March 15, 2022

Study Record Updates

• Last Update Posted (Actual): December 30, 2025
• Last Update Submitted That Met QC Criteria: December 9, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cold Injury; Wounds and Injuries; Frostbite
• Other Study ID Numbers: STUDY02001452

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No