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

University of Oslo (UIO)

Status: Terminated

Conditions: Wound (Morphologic Abnormality)

Treatments: Other: Hyperbaric oxygen treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT01270477

FROST

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Hyperbaric oxygen treatment

Experimental group

Description:

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

Treatment:

Other: Hyperbaric oxygen treatment