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DAHANCA-21

Hyperbaric oxygen treatment of mandibular osteoradionecrosis (DAHANCA 21)

DAHANCA-21

Hyperbaric oxygen treatment of mandibular osteoradionecrosis (DAHANCA 21)
Funding CRUK
Portfolio Cancer
Interventions Medicine
Randomised Yes
Status Closed
Start Date 12-May-2014

The objective of the study is to evaluate the effect of hyperbaric oxygen (HBO) on mandibular osteoradionecrosis (ORN)
as an adjunctive to surgical treatment in patients previously irradiated for head and neck cancer.
Potential patients will be identified in clinic assessed to confirm potential suitability for hyperbaric oxygen therapy.
Patients will be randomised to one of the following two arms:
Group I: participants will receive 30 preoperative HBO sessions and immediately thereafter surgical removal of the
necrotic bone/conservative treatment. Then, 10 postoperative HBO sessions.
Group II: participants do not receive HBO treatment, but Surgery/conservative treatment.
Patients randomised to HBO treatment will be compressed according to a standard profile used in the clinic. During
the first five minutes, the patient is compressed to 14,5 +/0,5
m (2,45 +/0,05
ATA) and stays here for the next 90
minutes. Decompression to the surface (0 m) will hereafter take place during five minutes. The patient will breathe
100% oxygen during the full 100minute
procedure inside a hood or mask. Each patient receives 30 preoperative
treatment and 10 postoperative treatments.
All patients with ORN grade >1 will be surgically treated according to standardised guidelines. The interventions
implies either
1. Resection of necrotic bone (sequestrectomy) with preservation of mandibular continuity.
2. Resection of necrotic bone (sequestrectomy) with loss of mandibular continuity.
The least mutilating intervention will be performed. Resection with loss of continuity will only be performed in case of
potential or stated fracture.
The protocol implies indication for Surgery, but during participation this indication may no longer be present. In this
case conservative treatment will be performed as 1) observation, 2) rinsing with sterile saline, antibiotics and/or 4 local
debridement.
Conservative treatment is performed in case initial healing is observed.
All patients are followed up for 12 months.

Publications

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