NCT00264511.

Trial name or title	"Does hyperbaric oxygen reduce complications and improve outcomes after open tibial fractures with severe soft tissue injury? An international multi‐centre randomized controlled trial."
Methods	Multi‐centre international randomised controlled trial
Participants	Estimated enrolment: 250 people with acute fracture of the tibia with significant soft tissue injury of Gustilo Grade 3; enrolment within 48 hours of injury with expectation of commencement of HBO therapy within 48 hours of injury, valid consent
Interventions	Hyperbaric oxygenation versus control
Outcomes	Primary outcome measures: acute phase complication rate; soft tissue necrosis; acute infection; compartment syndrome  Secondary outcome measures: amputation rate; late infection; radiological union; quality of life score; functional outcome scores
Starting date	February 2006
Contact information	Ian L Millar, I.millar@alfred.org.au Hyperbaric Service, The Alfred Hospital, PO BOX 315, Melbourne, Victoria 3004, Australia
Notes	Estimated study completion date: June 2012 This trial is also registered in India under a separate identifier: CTRI/2010/091/000369