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Sous Vide Therapy for Frostbite
N/A
Recruiting
Led By Nicholas Daniel, DO
Research Sponsored by Dartmouth-Hitchcock Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Acute frostbite of the hands and/or feet
Age <17 with parent or guardian consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 90 minutes
Awards & highlights
Study Summary
This trial will test whether using a sous vide device to heat and maintain a circulating warm water bath is more effective in the rewarming of acute frostbite than current methods.
Who is the study for?
This trial is for English-speaking adults with acute frostbite on their hands or feet. Minors can join if they have a parent or guardian's consent. It's not for those who cannot consent, don't understand English, have already thawed frostbite, or have frostbite on other body parts.Check my eligibility
What is being tested?
The study tests the effectiveness of sous vide devices in rewarming and maintaining warm water circulation for treating acute frostbite. Participants will use these devices to see how well they help heal affected areas.See study design
What are the potential side effects?
Potential side effects may include discomfort during treatment, possible burns from incorrect temperature settings, skin irritation from prolonged exposure to moisture, and infection risk due to improper device use.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have recent frostbite on my hands or feet.
Select...
I am under 17 and have my parent or guardian's consent.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 90 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 90 minutes
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rewarming
Time to rewarm in minutes
Secondary outcome measures
Ease of Use: Provider review
Trial Design
1Treatment groups
Experimental Treatment
Group I: Sous vide deviceExperimental Treatment1 Intervention
The intervention will be the use of a sous vide device to heat the water bath to 38 degrees celsius, rather than the traditional methods of manual water exchanges or placing the frostbitten tissue under running water.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sous Vide Device (SVD)
2021
N/A
~10
Find a Location
Who is running the clinical trial?
Dartmouth-Hitchcock Medical CenterLead Sponsor
524 Previous Clinical Trials
2,543,319 Total Patients Enrolled
1 Trials studying Frostbite
1 Patients Enrolled for Frostbite
Nicholas Daniel, DOPrincipal InvestigatorDartmouth-Hitchcock Medical Center
1 Previous Clinical Trials
1 Total Patients Enrolled
1 Trials studying Frostbite
1 Patients Enrolled for Frostbite
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have recent frostbite on my hands or feet.I have had frostbite on parts of my body other than my hands or feet.I have had frostbite, but it has already thawed.I am under 17 and have my parent or guardian's consent.I am under 18 and do not have a parent or guardian.I am unable to give consent by myself.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Sous vide device
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still vacant positions available in this clinical trial?
"The information presented on clinicaltrials.gov confirms that this trial is no longer recruiting patients, with its initial posting having been made on November 1st 2022 and the last update being conducted in June 2nd of the same year. However, there are still other medical studies looking for participants at present."
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