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| Sponsored by: |
University of Copenhagen |
|---|---|
| Information provided by: | University of Copenhagen |
| ClinicalTrials.gov Identifier: | NCT00760682 |
Purpose
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 HBO does improve healing after surgical removal of necrotic bone in irradiated previous head and neck cancer patients compared to not receiving HBO.
| Condition | Intervention | Phase |
|---|---|---|
|
Osteoradionecrosis |
Procedure: Hyperbaric oxygen |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study |
| Official Title: | Hyperbaric Oxygen Treatment of Mandibular Osteoradionecrosis. A Randomized Clinical Study |
| Estimated Enrollment: | 114 |
| Study Start Date: | June 2008 |
| Estimated Study Completion Date: | April 2011 |
| Estimated Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
30 preoperative HBO sessions, sequestrectomy and 10 postoperative HBO sessions. The duration of each session is 90 minutes. 100 % oxygen is inhaled during decompression to 2.4 ATA.
|
Procedure: Hyperbaric oxygen
30 preoperative and 10 postoperative HBO sessions 90 minutes each. Sequestrectomy is performed after 30 sessions.
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2: No Intervention
Sequestrectomy without HBO treatment
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Lone Forner, DDS; PhD | +45 35 45 82 11 | lone.forner@rh.regionh.dk |
| Contact: Erik Jansen, MD, DMSc | +45 35 45 12 57 | erik.jansen@rh.regionh.dk |
| Denmark | |
| Department of Anaesthesia, Copenhagen University Hospital | Recruiting |
| Copenhagen, Denmark, 2100 | |
| Contact: Lone Forner, DDS, PhD +45 35 45 82 11 lone.forner@rh.regionh.dk | |
| Contact: Erik Jansen, MD, DMSc +45 35 45 12 57 erik.jansen@rh.regionh.dk | |
| Principal Investigator: Lone Forner, DDS, PhD | |
| Principal Investigator: | Lone Forner, DDS, PhD | Copenhagen Trial Unit, Center for Clinical Intervention Research |
More Information
| Responsible Party: | Copenhagen University Hospital ( Lone Forner, DDS, PhD ) |
| Study ID Numbers: | DAHANCA 21 |
| Study First Received: | September 25, 2008 |
| Last Updated: | September 25, 2008 |
| ClinicalTrials.gov Identifier: | NCT00760682 |
| Health Authority: | Denmark: Danish Medicines Agency |
|
osteoradionecrosis hyperbaric oxygen sequestrectomy |
|
Wounds and Injuries Disorders of Environmental Origin Osteoradionecrosis Radiation Injuries |
