To investigate the efficacy of hyperbaric oxygen (HBO) in improving outcomes following open tibial fractures.

A prospective randomized controlled trial was conducted on patients presenting to an adult level 1 trauma centre with severe open tibial fractures (Gustillo 3B,3C). The primary outcome measure was soft tissue healing without secondary necrosis. Based on previously reported complication rates, 36 patients had to be randomized into each group in order to have ≥ 80% chance of detecting an improvement in necrosis free soft tissue healing rates from 70% to 95%. Secondary outcome measures included amputation, non-union, osteomyelitis and chronic pain rates, lower limb function and health related quality of life. The Alfred Hospital Human Research Ethics Committee approved conduct of the trial.

The trial was abandoned after 17 patients were randomised because the number of severe open tibial fractures presenting and complication rates were significantly lower than previously observed and because some surgeons declined to enrol patients in the belief that HBO was efficacious. Randomised patients were followed as per protocol but there were insufficient patients enrolled to observe any positive or negative differences in outcome. The logistics of treating major trauma patients with HBO proved readily manageable in the Alfred Hospital setting.

The efficacy of HBO in improving outcomes following open tibial fractures remains unknown. An international collaboration has been formed with the aim of commencing a multi-centre prospective randomized controlled trial of HBO in the near future.