Frostbite, Frostbite of Foot, Frostbite of Hand
Conditions
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.
Interventions
DEVICESous 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.
Sponsors
Dartmouth-Hitchcock Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rewarming | Up to 90 minutes | Assess if frostbitten extremities can be thawed in a warm water bath created by the experimental device. |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 0-10, where 0 indicates easy and 10 indicated difficult. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sous Vide Rewarming Group All patients with acute frostbite were approached for inclusion into the study group. | 7 |
| Total | 7 |
Baseline characteristics
| Characteristic | Sous Vide Rewarming Group | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 1 Participants | — |
| Age, Categorical Between 18 and 65 years | 6 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 7 participants | — |
| Sex: Female, Male Female | 1 Participants | — |
| Sex: Female, Male Male | 6 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 7 |
| other Total, other adverse events | 0 / 7 |
| serious Total, serious adverse events | 0 / 7 |
Outcome results
Primary
Rewarming
Assess if frostbitten extremities can be thawed in a warm water bath created by the experimental device.
Time frame: Up to 90 minutes
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sous Vide Rewarming Group | Rewarming | 7 Participants |
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
Time frame: Up to 90 minutes
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sous Vide Rewarming Group | Time to Rewarm in Minutes | 10 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 0-10, where 0 indicates easy and 10 indicated difficult.
Time frame: Immediately after rewarming, up to 90 minutes
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Sous Vide Rewarming Group | Ease of Use: Provider Review | 2.8 score on a scale |