Text Size

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
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
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:

U.S. FDA Resources

Further study details as provided by Singapore General Hospital:

Primary Outcome Measures:
  • Burns conversion [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

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
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

  Eligibility

Ages Eligible for Study:   21 Years to 60 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
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

ClinicalTrials.gov processed this record on May 23, 2013