Study Results
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View full resultsBasic Information
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COMPLETED
NA
1 participants
INTERVENTIONAL
2021-01-14
2021-05-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Sous vide device
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.
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 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.
Interventions
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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 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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Frostbite that has already thawed
* Frostbite of tissue other than hands or feet
* Inability to understand English
* Inability to provide consent
ALL
No
Sponsors
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Dartmouth-Hitchcock Medical Center
OTHER
Responsible Party
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Nicholas Daniel, DO
Assistant Professor
Principal Investigators
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Nicholas Daniel, DO
Role: PRINCIPAL_INVESTIGATOR
Dartmouth-Hitchcock Medical Center
Locations
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Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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D21002
Identifier Type: -
Identifier Source: org_study_id
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