Acute Thermal Burns Clinical Trial
Official title:
The Effects of Hyperbaric Oxygen Therapy on Acute Thermal Burns
| NCT number | NCT00824551 |
| Other study ID # | 1501 |
| Secondary ID | |
| Status | Recruiting |
| Phase | Phase 1 |
| First received | January 15, 2009 |
| Last updated | January 15, 2009 |
| Start date | January 2009 |
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.
| Status | Recruiting |
| Enrollment | 80 |
| Est. completion date | |
| Est. primary completion date | December 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 21 Years to 60 Years |
| Eligibility |
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) |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Singapore | Singapore General Hospital | Singapore |
| Lead Sponsor | Collaborator |
|---|---|
| Singapore General Hospital |
Singapore,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Burns conversion | 2 years | Yes | |
| Secondary | Bacteriology culture and immunology markers | 2 years | No |