Study hypothesis :Hyperbaric Oxygen may prevent complications and improve outcomes in severe lower limb trauma. We propose to investigate this hypothesis by conducting an International multi centre randomised control trial of standard trauma/orthopaedic care with or without a concurrent course of hyperbaric oxygen treatments.

A randomised controlled trial was undertaken on using hyperbaric oxygen in addition to standard orthopaedic trauma care in severe lower leg injury, defined as an open tibial fracture with severe soft tissue injury. The control arm subjects received standard hospital trauma care whilst the intervention group received standard trauma care with the addition of hyperbaric oxygen therapy with the aim of providing 12 HBOT sessions over the first 9 days of hospital care. The primary outcome measure was the incidence of wound necrosis AND/OR wound infection as assessed at Day 14, with secondary outcomes of wound closure, wound complications, infections and delayed bone union at 12 months plus quality of life and functional questionnaire outcomes at 12 months and 2 years.

The detailed study protocol was published in in June 2015 and the results were published in September 2022. Both publications are Open Access (See References section for publication details)

Inclusion Criteria:

• 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

Exclusion Criteria:

• Significant head injury
• Injuries incompatible with HBO
• resuscitation requirements incompatible with HBO
• follow up not possible
• hyperbaric contra indications

Surgeons initially operating were unaware of allocation. Outcomes arbitrations were conducted by surgeons blind to intervention allocation. Chief investigator masked until follow up data finally received and records locked.