Hyperbaric Oxygen in Lower Leg Trauma

Does Hyperbaric Oxygen Reduce Complications and Improve Outcomes After Open Tibial Fractures With Severe Soft Tissue Injury? An International Multi-centre Randomized Controlled Trial.

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)

Hyperbaric oxygen, Crush injury, Tibial fracture, Gustillo 3, soft tissue injury, complications, outcomes, randomised controlled trial

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.

Subjects in the HBO treatment group will receive a course of hyperbaric oxygen therapy (HBO) in addition to normal trauma and general care. A total of 12 HBO sessions will be delivered over approximately 8 days. HBO treatment will be provided at 2.4 atmospheres absolute (ATA) pressure for approximately 90 minutes of oxygen therapy. Treatments should be twice daily for the first three days. Minor variability will be allowed with respect to timing and profile of each session.

Subjects in the HBO treatment group will receive a course of hyperbaric oxygen therapy (HBO) in addition to normal trauma and general care. A total of 12 HBO sessions will be delivered over approximately 8 days. HBO treatment will be provided at 2.4 atmospheres absolute (ATA) pressure for approximately 90 minutes of oxygen therapy. Treatments should be twice daily for the first three days. Minor variability will be allowed with respect to timing and profile of each session.

The incidence of acute complications after injury. A composite measure defined as the occurrence within two weeks of trauma of one or both of: significant soft tissue necrosis developing after the initial surgery or significant wound infection.

Short Form 36 quality of life questionnaire (algorithm produces a score in the range of 0-100 with higher score better)

lower limb function component of Short Musculoskeletal Function Assessment ((each question is scored 1-5 with lower score better)

Any diagnosis of delayed union or non union or performance or scheduling of bone graft for union problems

Blinded evaluation of whether post traumatic wounds met the criteria for "Problem Wounds" as a result of requiring readmission to hospital, prolonged wound care, additional surgery or antibiotics that complicated or deteriorated patient recovery

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

Bouachour G, Cronier P, Gouello JP, Toulemonde JL, Talha A, Alquier P. Hyperbaric oxygen therapy in the management of crush injuries: a randomized double-blind placebo-controlled clinical trial. J Trauma. 1996 Aug;41(2):333-9. doi: 10.1097/00005373-199608000-00023.

Garcia-Covarrubias L, McSwain NE Jr, Van Meter K, Bell RM. Adjuvant hyperbaric oxygen therapy in the management of crush injury and traumatic ischemia: an evidence-based approach. Am Surg. 2005 Feb;71(2):144-51.

Millar IL, McGinnes RA, Williamson O, Lind F, Jansson KA, Hajek M, Smart D, Fernandes T, Miller R, Myles P, Cameron P. Hyperbaric Oxygen in Lower Limb Trauma (HOLLT); protocol for a randomised controlled trial. BMJ Open. 2015 Jun 11;5(6):e008381. doi: 10.1136/bmjopen-2015-008381.

Millar IL, Lind FG, Jansson KA, Hajek M, Smart DR, Fernandes TD, McGinnes RA, Williamson OD, Miller RK, Martin CA, Gabbe BJ, Myles PS, Cameron PA; HOLLT investigator group. Hyperbaric Oxygen for Lower Limb Trauma (HOLLT): an international multi-centre randomised clinical trial. Diving Hyperb Med. 2022 Sep 30;52(3):164-174. doi: 10.28920/dhm52.3.164-174.