Sous Vide Rewarming for Frostbitten Extremities

Not Applicable

Completed

• Conditions: Frostbite; Frostbite of Foot; Frostbite of Hand
• Interventions: Device: Sous Vide Device (SVD)

• Registration Number: NCT04633174
• Lead Sponsor: Dartmouth-Hitchcock Medical Center

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2020-11-11
• Study First Submitted QC: 2020-11-11
• Study First Posted: 2020-11-18
• Study Start: 2021-01-14
• Primary Completion: 2021-05-01
• Study Completion: 2021-05-01
• Status Verified: 2021-09
• Results First Submitted: 2021-09-01
• Results First Submitted QC: 2021-09-01
• Last Update Submitted: 2021-09-01
• Results First Posted: 2021-09-28
• Last Update Posted: 2021-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sous vide device	Sous Vide Device (SVD)	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.

Primary Outcome Measures

Name	Time	Method
Time to Rewarm in Minutes	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
Number of Limbs That Can be Rewarming Within 30 Minutes	30 minutes	Assess if frostbitten extremities can be rewarmed in 30 minutes at 38 degrees celsius using the experimental device

Secondary Outcome Measures

Name	Time	Method
Ease of Use: Provider Review of the Investigational Device and Standard of Care	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.

Trial Locations

Locations (1)

Dartmouth-Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States