Hyperbaric Oxygen Treatment as Adjuvant Treatment for Frost Injury

NCT ID: NCT01270477

Last Updated: 2021-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2020-03-03

Brief Summary

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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.

Detailed Description

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Conditions

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Wound (Morphologic Abnormality)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hyperbaric oxygen treatment

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

Group Type EXPERIMENTAL

Hyperbaric oxygen treatment

Intervention Type OTHER

Hyperbaric oxygen treatment for 2,5 hours at maximum 14 meters (standard table in Norway).

Interventions

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Hyperbaric oxygen treatment

Hyperbaric oxygen treatment for 2,5 hours at maximum 14 meters (standard table in Norway).

Intervention Type OTHER

Other Intervention Names

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Hyperoxic treatment Pressure chamber treatment

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Helle Midtgaard

Physiscian

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Knut Ar Kirkeboen, MD Professor

Role: STUDY_DIRECTOR

Oslo University Hospital

Locations

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Hyperbaric section Oslo University hospital

Oslo, , Norway

Site Status

Countries

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Norway

Other Identifiers

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FROST

Identifier Type: -

Identifier Source: org_study_id

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