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Completed

NCT Number: NCT05280301

Multicenter Sous Vide Frostbite

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.

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Key information

Conditions

Frostbite Cold Injury Frostbite of Foot Frostbite of Hand Wounds and Injuries

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sous Vide Device (SVD)

Device

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.

Primary outcomes

  1. Rewarming

    Time frame: Up to 90 minutes

    Assess if frostbitten extremities can be thawed in a warm water bath created by the experimental device.

  2. Time to Rewarm in Minutes

    Time frame: Up to 90 minutes

    Measure the time required to rewarm frostbitten extremities until the extremity is reddish or purple in coloration, and soft and pliable

Secondary outcomes

  1. Ease of Use: Provider Review

    Time frame: Immediately after rewarming, up to 90 minutes

    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.

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 15, 2022
Registry last updated
Dec 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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