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

March 2, 2021 updated by: Helle Midtgaard, Oslo University Hospital

Study of the Possible Improvement in Level of Sequela and Amputation/Amputation Level After Frost Injury by the Adjuvant Treatment of Hyperbaric Oxygen.

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0407
        • Hyperbaric section Oslo University hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
From incusion of a patiant through a follow up after 1 year.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
One year from the enrollment of a patient.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Investigators

  • Study Director: Knut Ar Kirkeboen, MD Professor, Oslo University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

March 3, 2020

Study Completion (Actual)

March 3, 2020

Study Registration Dates

First Submitted

January 3, 2011

First Submitted That Met QC Criteria

January 4, 2011

First Posted (Estimate)

January 5, 2011

Study Record Updates

Last Update Posted (Actual)

March 4, 2021

Last Update Submitted That Met QC Criteria

March 2, 2021

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FROST

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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