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

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ClinicalTrials.gov Identifier: NCT00824551
Recruitment Status : Unknown
Verified December 2008 by Singapore General Hospital.
Recruitment status was:  Recruiting
First Posted : January 16, 2009
Last Update Posted : January 16, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:

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 or disease Intervention/treatment Phase
Acute Thermal Burns Procedure: Hyperbaric Oxygen Therapy Other: Standard care Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Hyperbaric Oxygen Therapy on Acute Thermal Burns
Study Start Date : January 2009
Estimated Primary Completion Date : December 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Burns conversion [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Bacteriology culture and immunology markers [ Time Frame: 2 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00824551


Contacts
Contact: chong si jack 65-91467592 chong_si_jack@hotmail.com

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

Responsible Party: chong si jack, republic of singapore navy and singapore general hospital
ClinicalTrials.gov Identifier: NCT00824551     History of Changes
Other Study ID Numbers: 1501
First Posted: January 16, 2009    Key Record Dates
Last Update Posted: January 16, 2009
Last Verified: December 2008

Keywords provided by Singapore General Hospital:
Acute Thermal Burns
Hyperbaric Oxygen Therapy
Burns conversion

Additional relevant MeSH terms:
Burns
Wounds and Injuries