Sous Vide Rewarming for Frostbitten Extremities

Clinical Utilization of Sous Vide Cooking Devices in the 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)

• Study Type: Interventional
• Enrollment (Actual): 1
• 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: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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 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: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

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 38oC, 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 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Dartmouth-Hitchcock Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 14, 2021
• Primary Completion (ACTUAL): May 1, 2021
• Study Completion (ACTUAL): May 1, 2021

Study Registration Dates

• First Submitted: November 11, 2020
• First Submitted That Met QC Criteria: November 11, 2020
• First Posted (ACTUAL): November 18, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 28, 2021
• Last Update Submitted That Met QC Criteria: September 1, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Cold Injury; Frostbite
• Other Study ID Numbers: D21002

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