N/A
N=1
Sous Vide Rewarming for Frostbitten Extremities
Frostbite · Frostbite of Hand · Frostbite of Foot
Bottom Line
View on ClinicalTrials.gov: NCT04633174 ↗Enrolled (actual)
1
Serious AEs
0.0%
Results posted
Sep 2021
Primary outcome: Primary: Number of Limbs That Can be Rewarming Within 30 Minutes — 2 limbs
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Sous Vide Device (SVD) (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Dartmouth-Hitchcock Medical Center
- Primary completion
- May 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Limbs That Can be Rewarming Within 30 Minutes |
2 | — |
| PRIMARY Time to Rewarm in Minutes |
25 | — |
| SECONDARY Ease of Use: Provider Review of the Investigational Device and Standard of Care |
1; 3 | — |
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.
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT04633174). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.