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

Primary Purpose

Wound (Morphologic Abnormality)

Status
Terminated
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Hyperbaric oxygen treatment
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wound (Morphologic Abnormality) focused on measuring Frost injury

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hyperbaric section Oslo University hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hyperbaric oxygen treatment

Arm Description

Hyperbaric oxygen treatment in an hyperbaric oxygen treatment chamber on an recognized treatment table.

Outcomes

Primary Outcome Measures

Hyperbaric oxygen treatment is favorable for tissue regeneration after frost injury.

Secondary Outcome Measures

First: The number of surgeries is reduced with hyperbaric oxygen treatment.
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.

Full Information

First Posted
January 3, 2011
Last Updated
March 2, 2021
Sponsor
Oslo University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01270477
Brief Title
Hyperbaric Oxygen Treatment as Adjuvant Treatment for Frost Injury
Acronym
FROST
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 Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Terminated
Why Stopped
Lack of People to follow up the study, work overload
Study Start Date
January 2011 (undefined)
Primary Completion Date
March 3, 2020 (Actual)
Study Completion Date
March 3, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound (Morphologic Abnormality)
Keywords
Frost injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hyperbaric oxygen treatment
Arm Type
Experimental
Arm Description
Hyperbaric oxygen treatment in an hyperbaric oxygen treatment chamber on an recognized treatment table.
Intervention Type
Other
Intervention Name(s)
Hyperbaric oxygen treatment
Other Intervention Name(s)
Hyperoxic treatment, Pressure chamber treatment
Intervention Description
Hyperbaric oxygen treatment for 2,5 hours at maximum 14 meters (standard table in Norway).
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
First: The number of surgeries is reduced with hyperbaric oxygen treatment.
Description
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.
Time Frame
One year from the enrollment of a patient.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Knut Ar Kirkeboen, MD Professor
Organizational Affiliation
Oslo University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Hyperbaric section Oslo University hospital
City
Oslo
ZIP/Postal Code
0407
Country
Norway

12. IPD Sharing Statement

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Hyperbaric Oxygen Treatment as Adjuvant Treatment for Frost Injury

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