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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00264511
• Other study ID #: 206/04
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: February 13, 2007
• Est. completion date: March 23, 2016

Study information

• Verified date: August 2023
• Source: Bayside Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: March 23, 2016
• Est. primary completion date: August 18, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• Hyperbaric Oxygen Treatment
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.

Locations

Country	Name	City	State
Australia	Royal Hobart Hospital	Hobart	Tasmania
Australia	The Alfred	Melbourne	Victoria
Austria	Universitatsklinikum Graz	Graz
Chile	Hospital del Trabajador	Santiago
Czechia	City Hospital of Ostrava	Ostrava
India	Indraprastha Apollo Hospital	New Delhi	Sarita Vihar
Italy	Policlinico Umberto 1, University of Rome	Rome
Portugal	Hospital Pedro Hispano	Senhora da Hora	Matosinhos
Sweden	Karolinska Hospital	Stockholm
United States	John Muir Clinical Research Center	Concord	California

Sponsors (3)

Lead Sponsor	Collaborator
Bayside Health	Monash University, National Health and Medical Research Council, Australia

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Chile,  Czechia,  India,  Italy,  Portugal,  Sweden, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute phase complication rate	The incidence of acute complications after injury. A composite measure defined as the occurrence within two weeks of trauma of one or both of: significant soft tissue necrosis developing after the initial surgery or significant wound infection.	up to 14 days post trauma
Secondary	Amputation rate	operative procedure records of a limb amputation related to the trauma under study	3, 6, 9, 12, 18 and 24 months post trauma
Secondary	Late infection	records of diagnosis of wound infection or osteomyelitis or implant infection at defined times	3, 6, 9, 12, 18 and 24 months post trauma
Secondary	Radiological union	electronic image copies of radiographs recorded by treating hospitals	3, 6, 9, 12, 18 and 24 months post trauma
Secondary	Quality of life score	Short Form 36 quality of life questionnaire (algorithm produces a score in the range of 0-100 with higher score better)	3, 6, 9, 12, 18 and 24 months post trauma
Secondary	Functional outcome score	lower limb function component of Short Musculoskeletal Function Assessment ((each question is scored 1-5 with lower score better)	3, 6, 9, 12, 18 and 24 months post trauma
Secondary	Pain score	Subjects self reported pain using a 0-10 visual analogue scale	3, 6, 9, 12, 18 and 24 months post trauma
Secondary	Delayed union of fracture	Any diagnosis of delayed union or non union or performance or scheduling of bone graft for union problems	12 months post trauma
Secondary	Wound persistence	A record of whether any injury related wound remains open at review. Excludes new surgical wounds.	3, 6, 9, 12, 18 and 24 months post trauma
Secondary	Problem Wounds	Blinded evaluation of whether post traumatic wounds met the criteria for "Problem Wounds" as a result of requiring readmission to hospital, prolonged wound care, additional surgery or antibiotics that complicated or deteriorated patient recovery	12 months post trauma

External Links

•   HOLLT website