NCT01270477

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

January 3, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 5, 2011

Completed
9.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2020

Completed
Last Updated

March 4, 2021

Status Verified

April 1, 2011

Enrollment Period

9.2 years

First QC Date

January 3, 2011

Last Update Submit

March 2, 2021

Conditions

Wound (Morphologic Abnormality)

Keywords

Frost injury

Outcome Measures

Primary Outcomes (1)

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

    From incusion of a patiant through a follow up after 1 year.

Secondary Outcomes (1)

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

    One year from the enrollment of a patient.

Study Arms (1)

Hyperbaric oxygen treatment

EXPERIMENTAL

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

Other: Hyperbaric oxygen treatment

Interventions

Hyperbaric oxygen treatmentOTHER

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

Also known as: Hyperoxic treatment, Pressure chamber treatment
Hyperbaric oxygen treatment

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hyperbaric section Oslo University hospital

Oslo, 0407, Norway

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

  • Knut Ar Kirkeboen, MD Professor

    Oslo University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiscian

Study Record Dates

First Submitted

January 3, 2011

First Posted

January 5, 2011

Study Start

January 1, 2011

Primary Completion

March 3, 2020

Study Completion

March 3, 2020

Last Updated

March 4, 2021

Record last verified: 2011-04

Locations

NO(1)