NCT00264511

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2007

Longer than P75 for phase_2

Geographic Reach
8 countries

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 12, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 13, 2005

Completed
1.2 years until next milestone

Study Start

First participant enrolled

February 13, 2007

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 18, 2014

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2016

Completed
Last Updated

September 5, 2023

Status Verified

August 1, 2023

Enrollment Period

7.5 years

First QC Date

December 12, 2005

Last Update Submit

August 30, 2023

Conditions

Tibial FractureSoft Tissue Injury

Keywords

Hyperbaric oxygenCrush injuryTibial fractureGustillo 3soft tissue injurycomplicationsoutcomesrandomised controlled trial

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • Amputation rate

    3, 6, 9, 12, 18 and 24 months post trauma

  • Late infection

    3, 6, 9, 12, 18 and 24 months post trauma

  • Radiological union

    3, 6, 9, 12, 18 and 24 months post trauma

  • Quality of life score

    3, 6, 9, 12, 18 and 24 months post trauma

  • Functional outcome score

    3, 6, 9, 12, 18 and 24 months post trauma

  • +4 more secondary outcomes

Study Arms (2)

Hyperbaric oxygen treatment

EXPERIMENTAL

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.

Other: Hyperbaric Oxygen Treatment

No hyperbaric oxygenation

NO INTERVENTION

Patients randomised to this group will receive standard trauma care.

Interventions

Hyperbaric Oxygen TreatmentOTHER

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.

Also known as: Hyperbaric oxygen therapy, Hyperbaric Oxygen
Hyperbaric oxygen treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Significant head injury
  • Injuries incompatible with HBO
  • resuscitation requirements incompatible with HBO
  • follow up not possible
  • hyperbaric contra indications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

John Muir Clinical Research Center

Concord, California, 94520, United States

Location

Royal Hobart Hospital

Hobart, Tasmania, 7000, Australia

Location

The Alfred

Melbourne, Victoria, 3004, Australia

Location

Universitatsklinikum Graz

Graz, Austria

Location

Hospital del Trabajador

Santiago, Chile

Location

City Hospital of Ostrava

Ostrava, 728 80, Czechia

Location

Indraprastha Apollo Hospital

New Delhi, Sarita Vihar, 110076, India

Location

Policlinico Umberto 1, University of Rome

Rome, Italy

Location

Hospital Pedro Hispano

Senhora da Hora, Matosinhos, 4454-509, Portugal

Location

Karolinska Hospital

Stockholm, Sweden

Location

Related 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.

    PMID: 8760546BACKGROUND

  • 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.

    PMID: 16022014BACKGROUND

  • 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.

    PMID: 26068515BACKGROUND

  • 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.

    PMID: 36100927BACKGROUND

Related Links

MeSH Terms

Conditions

Tibial FracturesSoft Tissue InjuriesCrush Injuries

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

Oxygen Inhalation TherapyRespiratory TherapyTherapeutics

Study Officials

  • Ian L Millar, MBBS

    Bayside Health

    STUDY CHAIR

  • Owen Williamson

    Monash University

    PRINCIPAL INVESTIGATOR

  • Peter Cameron

    Monash University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Surgeons initially operating were unaware of allocation. Outcomes arbitrations were conducted by surgeons blind to intervention allocation. Chief investigator masked until follow up data finally received and records locked.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2005

First Posted

December 13, 2005

Study Start

February 13, 2007

Primary Completion

August 18, 2014

Study Completion

March 23, 2016

Last Updated

September 5, 2023

Record last verified: 2023-08

Locations

IN(1)IT(1)US(1)AU(2)PT(1)CL(1)CZ(1)SE(1)