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Completed

NCT Number: NCT04633174

Sous Vide Rewarming for 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.

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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

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 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 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.

Primary outcomes

  1. Number of Limbs That Can be Rewarming Within 30 Minutes

    Time frame: 30 minutes

    Assess if frostbitten extremities can be rewarmed in 30 minutes at 38 degrees celsius using 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 of the Investigational Device and Standard of Care

    Time frame: Immediately after rewarming, up to 90 minutes

    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.

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Nov 18, 2020
Registry last updated
Sep 28, 2021

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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