Hyperbaric Oxygen Treatment as Adjuvant Treatment for Frost Injury (FROST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by:
Oslo University Hospital

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.

Condition or disease Intervention/treatment Phase
Wound (Morphologic Abnormality) Other: Hyperbaric oxygen treatment Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : January 2011
Estimated Primary Completion Date : May 2012
Estimated Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy
U.S. FDA Resources

Arm Intervention/treatment
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).
Other Names:
  • Hyperoxic treatment
  • Pressure chamber treatment

Primary Outcome Measures :
  1. 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. ]

Secondary Outcome Measures :
  1. 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.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01270477

Contact: Helle Midtgaard, MD 990 15 653 ext +47
Contact: Halvard Stave, MD 95857482 ext +47

Hyperbaric section Oslo University hospital Recruiting
Oslo, Norway, 0407
Contact: Lene Mathisen, MD   
Principal Investigator: Helle Midtgaard, MD         
Sub-Investigator: Halvard Stave, MD         
Sponsors and Collaborators
Oslo University Hospital
Study Director: Knut Ar Kirkeboen, MD Professor Oslo University Hospital

Responsible Party: Oslo University hospital, Health south east, Norway Identifier: NCT01270477     History of Changes
Other Study ID Numbers: FROST
First Posted: January 5, 2011    Key Record Dates
Last Update Posted: April 19, 2011
Last Verified: April 2011

Keywords provided by Oslo University Hospital:
Frost injury

Additional relevant MeSH terms:
Wounds and Injuries