Multicenter Sous Vide Frostbite

Frostbite Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05280301
• Other study ID #: STUDY02001452
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: June 2023
• Source: Dartmouth-Hitchcock Medical Center
• Contact: Nicholas Daniel, DO
• Phone: 651-216-4893
• Email: Nicholas.Daniel[@]hitchcock.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Frostbite
• Frostbite of Foot
• Frostbite of Hand

Intervention

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 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.

Locations

Country	Name	City	State
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rewarming	Assess if frostbitten extremities can be thawed in a warm water bath created by the experimental device.	Up to 90 minutes
Primary	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	Ease of Use: Provider review	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.	Immediately after rewarming, up to 90 minutes