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

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.