Sous Vide Rewarming for Frostbitten Extremities

NCT04633174 | Completed Results FDA Device

• 1 other identifier: D21002
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Frostbite; Frostbite of Hand; Frostbite of Foot

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Ease of Use: Provider Review of the Investigational Device and Standard of Care

  Immediately after rewarming, up to 90 minutes

Study Arms (1)

Sous vide device

EXPERIMENTAL

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)

Interventions

Sous Vide Device (SVD) DEVICE

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.

Sous vide device

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Conditions

Frostbite

Condition Hierarchy (Ancestors)

Cold Injury; Wounds and Injuries

Limitations and Caveats

The recruitment period was limited to one winter season (Winter 2020-2021). During the recruitment period, only one patient was seen for frostbite.

Results Point of Contact

• Title: Dr. Nicholas Daniel, Staff Physician, Emergency Services
• Organization: Dartmouth-Hitchcock Medical Center

Nicholas.Daniel@hitchcock.org

(603) 650-7254

Study Officials

• Nicholas Daniel, DO

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 11, 2020
• First Posted: November 18, 2020
• Study Start: January 14, 2021
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2021
• Last Updated: September 28, 2021
• Results First Posted: September 28, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)