Multicenter Sous Vide Frostbite

Not Applicable

Completed

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

• Registration Number: NCT05280301
• 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

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 Timeline

• Study First Submitted: 2022-03-02
• Study First Submitted QC: 2022-03-12
• Study First Posted: 2022-03-15
• Study Start: 2022-12-01
• Primary Completion: 2024-11-25
• Study Completion: 2024-11-25
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-09
• Last Update Posted: 2024-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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 & 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 38 degrees celsius, 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
Rewarming	Up to 90 minutes	Assess if frostbitten extremities can be thawed in a warm water bath created by the experimental device.

Secondary Outcome Measures

Name	Time	Method
Ease of Use: Provider review	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 1-10, where 0 indicates easy and 10 indicated difficult.

Trial Locations

Locations (1)

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