Hyperbaric Oxygen in Lower Leg Trauma

Bayside Health

Status and phase: Completed; Phase 3; Phase 2

Conditions: Tibial Fracture; Soft Tissue Injury

Treatments: Other: Hyperbaric Oxygen Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT00264511

206/04

Details and patient eligibility

About

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.

Full 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)

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

120 participants in 2 patient groups

Hyperbaric oxygen treatment

Experimental group

Description:

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.

Treatment:

Other: Hyperbaric Oxygen Treatment

No hyperbaric oxygenation

No Intervention group

Description:

Patients randomised to this group will receive standard trauma care.