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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Oslo University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01270477
First received: January 3, 2011
Last updated: April 18, 2011
Last verified: April 2011
  Purpose

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 Intervention
Wound (Morphologic Abnormality)
Other: Hyperbaric oxygen treatment

Study Type: Interventional
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.

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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.



Estimated Enrollment: 20
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)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01270477

Contacts
Contact: Helle Midtgaard, MD 990 15 653 ext +47 helle@fue.no
Contact: Halvard Stave, MD 95857482 ext +47 hstave@gmail.com

Locations
Norway
Hyperbaric section Oslo University hospital Recruiting
Oslo, Norway, 0407
Contact: Lene Mathisen, MD       mathisen_lene@hotmail.com   
Principal Investigator: Helle Midtgaard, MD         
Sub-Investigator: Halvard Stave, MD         
Sponsors and Collaborators
Oslo University Hospital
Investigators
Study Director: Knut Ar Kirkeboen, MD Professor Oslo University hospital, Norway
  More Information

No publications provided

Responsible Party: Oslo University hospital, Health south east, Norway
ClinicalTrials.gov Identifier: NCT01270477     History of Changes
Other Study ID Numbers: FROST
Study First Received: January 3, 2011
Last Updated: April 18, 2011
Health Authority: Norway: Ethics Committee

Keywords provided by Oslo University Hospital:
Frost injury

Additional relevant MeSH terms:
Wounds and Injuries

ClinicalTrials.gov processed this record on October 21, 2014