Hyperbaric Oxygen Treatment as Adjuvant Treatment for Frost Injury (FROST)
|ClinicalTrials.gov Identifier: NCT01270477|
Recruitment Status : Unknown
Verified April 2011 by Oslo University Hospital.
Recruitment status was: Recruiting
First Posted : January 5, 2011
Last Update Posted : April 19, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Wound (Morphologic Abnormality)||Other: Hyperbaric oxygen treatment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||January 2011|
|Estimated Primary Completion Date :||May 2012|
|Estimated Study Completion Date :||October 2012|
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).
- 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. ]
- First: The number of surgeries is reduced with hyperbaric oxygen treatment. [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01270477
|Contact: Helle Midtgaard, MD||990 15 653 ext +firstname.lastname@example.org|
|Contact: Halvard Stave, MD||95857482 ext +email@example.com|
|Hyperbaric section Oslo University hospital||Recruiting|
|Oslo, Norway, 0407|
|Contact: Lene Mathisen, MD firstname.lastname@example.org|
|Principal Investigator: Helle Midtgaard, MD|
|Sub-Investigator: Halvard Stave, MD|
|Study Director:||Knut Ar Kirkeboen, MD Professor||Oslo University Hospital|