Hyperbaric Oxygen in Lower Leg Trauma - Full Text View

Purpose

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.

Condition	Intervention	Phase
Tibial Fracture Soft Tissue Injury	Procedure: Hyperbaric Oxygenation	Phase II Phase III

MedlinePlus related topics:

Fractures Injuries Wounds

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study

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.

Further study details as provided by Bayside Health:

Primary Outcome Measures:

Acute phase complication rate
soft tissue necrosis
acute infection
compartment syndrome

Secondary Outcome Measures:

amputation rate
late infection
radiological union
quality of life score
functional outcome scores

Estimated Enrollment:	250
Study Start Date:	February 2006
Estimated Study Completion Date:	June 2010

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Acute fracture of the tibia with significant soft tissue injury of Gustilo Grade 3
Enrolment within 24 hours of injury with expectation of commencement of HBO therapy within 24 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00264511

Contacts


Contact: Ian L Millar, MBBS	+61 3 9276 2269	I.millar@alfred.org.au

Contact: Project Coordinator	+61 3 9903 0926	HOLLT@med.monash.edu.au

Locations


United States, Arizona
	Scottsdale Healthcare Osborn	Recruiting
	Phoenix, Arizona, United States, 85251
	Contact: Dennis E Weiland, MD
	Contact: Brandy Sevarlic, RN, MSN
	Principal Investigator: Dennis E Weiland, MD

United States, Connecticut
	The Hartford Hospital	Not yet recruiting
	Hartford, Connecticut, United States
	Contact: George Perdrizet, MD,PhD,FACS
	Principal Investigator: George Perdrizet, MD,PhD,FACS

Australia, Victoria
	The Alfred	Recruiting
	Melbourne, Victoria, Australia, 3004
	Contact: Ian L Millar, MBBS
	Contact: Cate Venturoni, RN
	Principal Investigator: Ian L Millar, MBBS

Austria
	Universitatsklinikum Graz	Recruiting
	Graz, Austria
	Contact: Beatrice Ratzenhofer-Komenda, MD
	Principal Investigator: Franz Seibert, MD
	Principal Investigator: Freyja Smolle-Juttner
	Principal Investigator: Beatrice Ratzenhofer-Komenda, MD

Czech Republic
	Charles University Hospital, Pilsen	Recruiting
	Pilsen, Czech Republic
	Contact: Jiri Ruzicka
	Principal Investigator: Jiri Ruzicka

Germany, Bayern
	BG Unfallklinik Murnau	Not yet recruiting
	Murnau, Bayern, Germany
	Contact: Armin Kemmer
	Principal Investigator: Armin Kemmer
	Principal Investigator: Holger Schoeppenthau, MD

Italy
	Policlinico Umberto 1, University of Rome	Recruiting
	Rome, Italy
	Contact: Monica Rocco, MD
	Principal Investigator: Monica Rocco, MD

Sweden
	Karolinska Hospital	Recruiting
	Stockholm, Sweden
	Contact: Folke Lind, MD, PhD
	Principal Investigator: Folke Lind, MD, PhD

Sponsors and Collaborators

Bayside Health

Investigators


Study Chair:	Ian L Millar, MBBS	Bayside Health

Principal Investigator:	Owen Williamson	Monash University

Principal Investigator:	Peter Cameron	Monash University

More Information

Publications:

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.

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. Review.

Study ID Numbers:	206/04
First Received:	December 12, 2005
Last Updated:	April 9, 2008
ClinicalTrials.gov Identifier:	NCT00264511
Health Authority:	Australia: National Health and Medical Research Council

Keywords provided by Bayside Health:

Hyperbaric oxygen

Crush injury

Tibial fracture

Gustillo 3

soft tissue injury

complications

outcomes

randomised controlled trial

Study placed in the following topic categories:

Soft Tissue Injuries

Fractures, Bone

Wounds and Injuries

Disorders of Environmental Origin

Leg Injuries

Tibial Fractures

ClinicalTrials.gov processed this record on October 10, 2008

Sponsored by:	Bayside Health
Information provided by:	Bayside Health
ClinicalTrials.gov Identifier:	NCT00264511