The Effects of Hyperbaric Oxygen Therapy (HBOT) on Acute Thermal Burns - Full Text View

Sponsor:	Singapore General Hospital
Information provided by:	Singapore General Hospital
ClinicalTrials.gov Identifier:	NCT00824551

Purpose

The blinded RCTstudy aims to:

Determine the effects of HBOT on burns conversion for patients who have fresh thermal burns injury using the LDI.
Objectively determine the proportion of burns conversion in areas of partial thickness burns for early thermal burns injury in both arms of the RCT.
Study the effects of HBOT on immunological markers IL-1, IL-2, IL-4, IL-6, IL-8, IL-10, TNF-α and TGF-β ( comparison between both arms and 2 assessment points).
Study the effect of HBOT on haematological markers including procalcitonin ,albumin, lymphocyte counts, neutrophil count, and macrophage count.
Study the effects of HBOT on histology specimens in quantifying P53 protein, leukocyte and macrophage infiltration, burns depth assessment and vascular endothelial growth factor (VEGF) and inducible nitric oxide synthase (iNOS) .
Study the effects of HBOT on bacteriology of tissue culture in areas of deep dermal burns.

Condition	Intervention	Phase
Acute Thermal Burns	Procedure: Hyperbaric Oxygen Therapy Other: Standard care	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Control: Active Control Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	The Effects of Hyperbaric Oxygen Therapy on Acute Thermal Burns

Resource links provided by NLM:

MedlinePlus related topics: Burns Oxygen Therapy

Further study details as provided by Singapore General Hospital:

Primary Outcome Measures:

Secondary Outcome Measures:

Bacteriology culture and immunology markers [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	80
Study Start Date:	January 2009
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Hyperbaric Oxygen Therapy: Experimental 2 HBOT treatments	Procedure: Hyperbaric Oxygen Therapy 2 sessions of HBOT ( HDMC 14)
2: Active Comparator Standard care and treatment	Other: Standard care Patient will undergo standard care

Eligibility

Criteria

Inclusion Criteria:

Thermal burns injury less than 40% with areas of deep dermal/ full thickness burns.
Less than 24 hours from time of injury.
No inhalational injury (Nasoendoscopy and bronchoscopic diagnosis by burns centre medical team/ department of emergency medicine in SGH).
Age 21 years old and above and less than 60 years old.
Not intubated and not on inotropic support.
Understands and agrees to informed consent (approved by IRB SGH).

Exclusion Criteria:

Untreated pneumothorax
Medications: Bleomycin, Cis-platin, Doxorubicin, Disulfiram (Chemotherapy)
Acute uncontrolled medical condition or significant medical condition (eg. Cerebrovascular accident, diabetic ketoacidosis, severe hypertensive 180/ 110 mmHg, end stage renal failure, chest pain, bleeding gastrointestinal tract, coma and acute asthma attack)
Other surgical emergencies (eg. open fractures, compartment syndrome and acute abdomen)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00824551

Contacts

Contact: chong si jack

65-91467592

Locations

Singapore
Singapore General Hospital	Recruiting
Singapore, Singapore, 169608
Contact: chong si jack , mbbs,m.med 65-91467592 chong_si_jack@hotmail.com

Sponsors and Collaborators

Singapore General Hospital

More Information

No publications provided

Responsible Party:	republic of singapore navy and singapore general hospital ( chong si jack )
ClinicalTrials.gov Identifier:	NCT00824551 History of Changes
Other Study ID Numbers:	1501
Study First Received:	January 15, 2009
Last Updated:	January 15, 2009
Health Authority:	Singapore: Health Sciences Authority

Keywords provided by Singapore General Hospital:

Acute Thermal Burns
Hyperbaric Oxygen Therapy
Burns conversion

Additional relevant MeSH terms:

Burns
Wounds and Injuries
Disorders of Environmental Origin

ClinicalTrials.gov processed this record on August 31, 2010