Wound (Morphologic Abnormality)
Conditions
Keywords
Frost injury
Brief summary
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.
Interventions
Hyperbaric oxygen treatment for 2,5 hours at maximum 14 meters (standard table in Norway).
Sponsors
Oslo University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| First: The number of surgeries is reduced with hyperbaric oxygen treatment. | One year from the enrollment of a patient. | 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. |
Countries
Norway
Outcome results
None listed