Hyperbaric Oxygen in Lower Leg Trauma

Tibial Fracture Clinical Trial

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

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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) ;

Related Conditions & MeSH terms

• Fractures, Bone
• Soft Tissue Injuries
• Soft Tissue Injury
• Tibial Fracture
• Tibial Fractures
• Wounds and Injuries

• NCT number: NCT00264511
• Study type: Interventional
• Source: Bayside Health
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: February 13, 2007
• Completion date: March 23, 2016