Wound (Morphologic Abnormality) Clinical Trial
— FROSTOfficial title:
Study of the Possible Improvement in Level of Sequela and Amputation/Amputation Level After Frost Injury by the Adjuvant Treatment of Hyperbaric Oxygen.
| NCT number | NCT01270477 |
| Other study ID # | FROST |
| Secondary ID | |
| Status | Terminated |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | January 2011 |
| Est. completion date | March 3, 2020 |
| Verified date | April 2011 |
| Source | Oslo University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 20 |
| Est. completion date | March 3, 2020 |
| Est. primary completion date | March 3, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 70 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Norway | Hyperbaric section Oslo University hospital | Oslo |
| Lead Sponsor | Collaborator |
|---|---|
| Oslo University Hospital |
Norway,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Hyperbaric oxygen treatment is favorable for tissue regeneration after frost injury. | From incusion of a patiant through a follow up after 1 year. | ||
| Secondary | 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. |