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Clinical Trials/NCT00824551
NCT00824551UnknownPhase 1

The Effects of Hyperbaric Oxygen Therapy on Acute Thermal Burns

Singapore General Hospital2 sites in 1 country80 target enrollmentStarted: January 2009Last updated:
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Conditions

Trial Snapshot

Phase
Phase 1
Enrollment
80
Locations
2
Primary Endpoint
Burns conversion
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
21 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Outcomes

Primary Outcomes

Burns conversion

Time Frame: 2 years

Secondary Outcomes

  • Bacteriology culture and immunology markers(2 years)

Investigators

Sponsor Class
Other

Study Sites (2)

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The Effects of Hyperbaric Oxygen Therapy... | Clinical Trial