Status:
UNKNOWN
Hyperbaric Oxygen Treatment of Mandibular Osteoradionecrosis. A Randomized Clinical Study
Lead Sponsor:
Lone Forner
Conditions:
Osteoradionecrosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
There is currently not sufficient evidence that hyperbaric oxygen (HBO) benefits the surgical removal of necrotic bone in osteoradionecrosis patients. This study aims at testing the hypothesis that HB...
Detailed Description
1. Study objective The objective of the study is to evaluate the effect of hyperbaric oxygen (HBO) on mandibular osteoradionecrosis as an adjunctive to surgical treatment in patients previously ir...
Eligibility Criteria
Inclusion
- Osteoradionecrosis grade 2, 3 or 4 according to the CTCAE v 3.0 criteria
- Localized to the mandibula
- \> 18 yrs old
Exclusion
- Existing malignant disease
- Previous HBO
- Pregnancy or lactation
- Uncontrollable claustrophobia
- Undrained pneumothorax
- Blood pressure \> 220/110
- Exposed titanium reconstruction device
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2015
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT00760682
Start Date
June 1 2008
End Date
April 1 2015
Last Update
May 25 2012
Active Locations (4)
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1
Aarhus University Hospital
Aarhus, Denmark
2
Department of Anaesthesia, Copenhagen University Hospital
Copenhagen, Denmark, 2100
3
Sahlgrenska Universitet
Gothenburg, Sweden
4
Aintree University Hospital
Liverpool, United Kingdom