Hyperbaric Oxygen Treatment as Adjuvant Treatment for Frost Injury (FROST)
Recruitment status was Recruiting
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Study of the Possible Improvement in Level of Sequela and Amputation/Amputation Level After Frost Injury by the Adjuvant Treatment of Hyperbaric Oxygen.|
- Hyperbaric oxygen treatment is favorable for tissue regeneration after frost injury. [ Time Frame: From incusion of a patiant through a follow up after 1 year. ] [ Designated as safety issue: No ]
- First: The number of surgeries is reduced with hyperbaric oxygen treatment. [ Time Frame: One year from the enrollment of a patient. ] [ Designated as safety issue: No ]
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.
|Study Start Date:||January 2011|
|Estimated Study Completion Date:||October 2012|
|Estimated Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
Experimental: Hyperbaric oxygen treatment
Hyperbaric oxygen treatment in an hyperbaric oxygen treatment chamber on an recognized treatment table.
Other: Hyperbaric oxygen treatment
Hyperbaric oxygen treatment for 2,5 hours at maximum 14 meters (standard table in Norway).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01270477
|Contact: Helle Midtgaard, MD||990 15 653 ext +email@example.com|
|Contact: Halvard Stave, MD||95857482 ext +firstname.lastname@example.org|
|Hyperbaric section Oslo University hospital||Recruiting|
|Oslo, Norway, 0407|
|Contact: Lene Mathisen, MD email@example.com|
|Principal Investigator: Helle Midtgaard, MD|
|Sub-Investigator: Halvard Stave, MD|
|Study Director:||Knut Ar Kirkeboen, MD Professor||Oslo University hospital, Norway|