Trial Outcomes & Findings for Multicenter Sous Vide Frostbite (NCT NCT05280301)

Results Overview

Assess if frostbitten extremities can be thawed in a warm water bath created by the experimental device.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

7 participants

Primary outcome timeframe

Up to 90 minutes

Results posted on

2025-12-30

Participant Flow

Participant milestones

Participant milestones
Measure	Sous Vide Rewarming Group All patients with acute frostbite were approached for inclusion into the study group.
Overall Study STARTED	7
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sous Vide Rewarming Group n=7 Participants All patients with acute frostbite were approached for inclusion into the study group.
Age, Categorical <=18 years	0 Participants n=7 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=7 Participants
Age, Categorical >=65 years	1 Participants n=7 Participants
Sex: Female, Male Female	1 Participants n=7 Participants
Sex: Female, Male Male	6 Participants n=7 Participants
Region of Enrollment United States	7 participants n=7 Participants

PRIMARY outcome

Timeframe: Up to 90 minutes

Assess if frostbitten extremities can be thawed in a warm water bath created by the experimental device.

Outcome measures

Outcome measures
Measure	Sous Vide Rewarming Group n=7 Participants All patients with acute frostbite were approached for inclusion into the study group.
Rewarming	7 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Sous Vide Rewarming Group n=7 Participants All patients with acute frostbite were approached for inclusion into the study group.
Time to Rewarm in Minutes	10 Minutes Interval 7.0 to 13.0

SECONDARY outcome

Timeframe: 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 0-10, where 0 indicates easy and 10 indicated difficult.

Outcome measures

Outcome measures
Measure	Sous Vide Rewarming Group n=7 Participants All patients with acute frostbite were approached for inclusion into the study group.
Ease of Use: Provider Review	2.8 score on a scale Interval 1.0 to 7.0

Adverse Events

Sous Vide Rewarming Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Nicholas Daniel

Dartmouth-Hitchcock

Phone: 603-650-5000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place