TerminatedInterventionalPhase 3Updated Jan 12, 2016
The Effects of Hyperbaric Oxygen Therapy (HBOT) on Acute Thermal Burns | NCT00824551 | Trialant
Unknown statusInterventionalPhase 1Updated Jan 16, 2009
The Effects of Hyperbaric Oxygen Therapy (HBOT) on Acute Thermal Burns
The Effects of Hyperbaric Oxygen Therapy on Acute Thermal Burns
ClinicalTrials.gov ID
NCT00824551
Lead Sponsor
Singapore General HospitalOTHER
Overall Status
Unknown status
Study Type
Interventional
Phase
Phase 1
Enrollment
80Estimated
Last Update Posted
Jan 16, 2009Estimated
Start Date
Jan 2009
Primary Completion Date
Dec 2010Estimated
Official Title
The Effects of Hyperbaric Oxygen Therapy on Acute Thermal Burns
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.
Acute Thermal Burns
Hyperbaric Oxygen Therapy
Standard care
Ages Eligible for Study
Adult (18-64)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
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).
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)