Clinical trial NCT00264511: Hyperbaric Oxygen in Lower Leg Trauma
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Tibial Fracture
Soft Tissue Injury
Keywords: Hyperbaric oxygen
Crush injury
Tibial fracture
Gustillo 3
soft tissue injury
complications
outcomes
randomised controlled trial
Lead sponsor: Bayside Health
Sponsor class: OTHER_GOV
Collaborators: name: Monash University
name: National Health and Medical Research Council, Australia
First posted: 2005-12-13
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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)

Eligibility criteria: 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

Primary outcomes:
measure: Acute phase complication rate
timeFrame: up to 14 days post trauma
Secondary outcomes:
measure: Amputation rate
timeFrame: 3, 6, 9, 12, 18 and 24 months post trauma
measure: Late infection
timeFrame: 3, 6, 9, 12, 18 and 24 months post trauma
measure: Radiological union
timeFrame: 3, 6, 9, 12, 18 and 24 months post trauma
measure: Quality of life score
timeFrame: 3, 6, 9, 12, 18 and 24 months post trauma
measure: Functional outcome score
timeFrame: 3, 6, 9, 12, 18 and 24 months post trauma
measure: Pain score
timeFrame: 3, 6, 9, 12, 18 and 24 months post trauma
measure: Delayed union of fracture
timeFrame: 12 months post trauma
measure: Wound persistence
timeFrame: 3, 6, 9, 12, 18 and 24 months post trauma
measure: Problem Wounds
timeFrame: 12 months post trauma
Other outcomes:
Locations:
city: Concord
country: United States
facility: John Muir Clinical Research Center
state: California
city: Hobart
country: Australia
facility: Royal Hobart Hospital
state: Tasmania
city: Melbourne
country: Australia
facility: The Alfred
state: Victoria
city: Graz
country: Austria
facility: Universitatsklinikum Graz
city: Santiago
country: Chile
facility: Hospital del Trabajador
city: Ostrava
country: Czechia
facility: City Hospital of Ostrava
city: New Delhi
country: India
facility: Indraprastha Apollo Hospital
state: Sarita Vihar
city: Rome
country: Italy
facility: Policlinico Umberto 1, University of Rome
city: Senhora da Hora
country: Portugal
facility: Hospital Pedro Hispano
state: Matosinhos
city: Stockholm
country: Sweden
facility: Karolinska Hospital
Study officials:
affiliation: Bayside Health
name: Ian L Millar, MBBS
role: STUDY_CHAIR
affiliation: Monash University
name: Owen Williamson
role: PRINCIPAL_INVESTIGATOR
affiliation: Monash University
name: Peter Cameron
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.