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Hyperbaric Oxygen in Lower Limb Trauma (HOLLT); protocol for a randomised controlled trial.

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Hyperbaric oxygen therapy may reduce complications in severe open tibia fractures. This trial investigates its effectiveness in preventing acute complications and improving long-term outcomes for trauma patients.

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Area of Science:

  • Orthopaedic Trauma Surgery
  • Hyperbaric Medicine
  • Wound Healing Research

Background:

  • Severe open fractures with soft tissue injury carry high complication risks, including infection and non-union.
  • Current treatments often necessitate multiple surgeries and prolonged rehabilitation.
  • Hyperbaric oxygen therapy (HBOT) is explored as an adjunct to improve outcomes in musculoskeletal trauma.

Purpose of the Study:

  • To evaluate the efficacy of HBOT as an adjunct to standard care for severe open tibia fractures.
  • To determine if HBOT reduces acute complications and improves functional outcomes.
  • To assess the impact of HBOT on long-term results in high-risk trauma patients.

Main Methods:

  • International, multicentre, randomized, open-label clinical trial.
  • Recruitment of patients with Gustilo grade 3 open tibia fractures and high risk of complications.
  • Intervention: 12 sessions of HBOT within 48 hours of injury; primary outcome: acute complications at 14 days; secondary outcomes: amputation, wound closure, fixation time, operative procedures, and hospital stay; 2-year follow-up.

Main Results:

  • Primary outcome data on acute complications at 14 days will be analyzed.
  • Secondary outcomes including amputation rates, wound healing, and need for further surgery will be assessed.
  • Long-term functional outcomes and complication rates will be monitored for 2 years post-injury.

Conclusions:

  • This study aims to provide significant evidence on the role of HBOT in managing severe lower limb trauma.
  • Results will clarify whether HBOT can significantly improve outcomes and reduce complications in this patient population.
  • Findings will be disseminated through international journals and conferences to inform clinical practice.