Hyperbaric Oxygen Treatment as Adjuvant Treatment for Frost Injury

Not Applicable

Terminated

• Conditions: Wound (Morphologic Abnormality)
• Interventions: Other: Hyperbaric oxygen treatment

• Registration Number: NCT01270477
• Lead Sponsor: Oslo University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-03
• Study First Submitted QC: 2011-01-04
• Study First Posted: 2011-01-05
• Status Verified: 2011-04
• Primary Completion: 2020-03-03
• Study Completion: 2020-03-03
• Last Update Submitted: 2021-03-02
• Last Update Posted: 2021-03-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hyperbaric oxygen treatment	Hyperbaric oxygen treatment	Hyperbaric oxygen treatment in an hyperbaric oxygen treatment chamber on an recognized treatment table.

Primary Outcome Measures

Name	Time	Method
Hyperbaric oxygen treatment is favorable for tissue regeneration after frost injury.	From incusion of a patiant through a follow up after 1 year.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hyperbaric section Oslo University hospital; 🇳🇴 Oslo, Norway