Hyperbaric Oxygen Treatment as Adjuvant Treatment for Frost Injury

Study Overview
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Brief Summary
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The aim of this study is to see weather hyperbaric oxygen treatment is beneficial as adjuvant treatment for frost damage. The investigators hope to include at least 20 patients in a randomized manner. Half of the patients are randomized to hyperbaric oxygen, and half of the patients are randomized not to have hyperbaric oxygen treatment. Under hypotheses: The number og surgeries is reduced by hyperbaric oxygen treatment as adjuvant treatment for frost damage. The functional level of the frost damaged patient is better after 6 and 12 months when also treated with hyperbaric oxygen treatment for frost damage.

Official Title
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Study of the Possible Improvement in Level of Sequela and Amputation/Amputation Level After Frost Injury by the Adjuvant Treatment of Hyperbaric Oxygen.

Conditions
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Wound (Morphologic Abnormality)

Intervention / Treatment
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* Other: Hyperbaric oxygen treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-70. Frost damage grade II-IV. Inclusion is needed within 48 hours from time of damage. Exclusion Criteria: Pregnancy. Ventilator treatment. Problems with equalizing. High grade heart failure. Chronic obstructive lung disease of high grade. Treatment over 3 days after time of damage. Serious claustrophobia/psychiatric illness.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hyperbaric oxygen treatment<br>Hyperbaric oxygen treatment in an hyperbaric oxygen treatment chamber on an recognized treatment table. | Other: Hyperbaric oxygen treatment<br>* Hyperbaric oxygen treatment for 2,5 hours at maximum 14 meters (standard table in Norway).<br>* Other names: Pressure chamber treatment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hyperbaric oxygen treatment is favorable for tissue regeneration after frost injury. |  | From incusion of a patiant through a follow up after 1 year. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First: The number of surgeries is reduced with hyperbaric oxygen treatment. | Second: The level of amputation is further distal on the extremity with hyperbaric oxygen treatment. Third: The level of function of the damaged bodypart is better after 6 and 12 months with hyperbaric treatment. | One year from the enrollment of a patient. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Frost injury