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 |