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The Effects of Hyperbaric Oxygen Therapy (HBOT) on Acute Thermal Burns

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2008 by Singapore General Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Singapore General Hospital
ClinicalTrials.gov Identifier:
NCT00824551
First received: January 15, 2009
Last updated: NA
Last verified: December 2008
History: No changes posted

January 15, 2009
January 15, 2009
January 2009
December 2010   (final data collection date for primary outcome measure)
Burns conversion [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
Bacteriology culture and immunology markers [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Effects of Hyperbaric Oxygen Therapy (HBOT) on Acute Thermal Burns
The Effects of Hyperbaric Oxygen Therapy on Acute Thermal Burns

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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Acute Thermal Burns
  • Procedure: Hyperbaric Oxygen Therapy
    2 sessions of HBOT ( HDMC 14)
  • Other: Standard care
    Patient will undergo standard care
  • Experimental: Hyperbaric Oxygen Therapy
    2 HBOT treatments
    Intervention: Procedure: Hyperbaric Oxygen Therapy
  • Active Comparator: 2
    Standard care and treatment
    Intervention: Other: Standard care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
Not Provided
December 2010   (final data collection date for primary outcome measure)

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)
Both
21 Years to 60 Years
No
Contact: chong si jack 65-91467592 chong_si_jack@hotmail.com
Singapore
 
NCT00824551
1501
Yes
chong si jack, republic of singapore navy and singapore general hospital
Singapore General Hospital
Not Provided
Not Provided
Singapore General Hospital
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP