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

Study Overview
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Brief Summary
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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.

Official Title
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The Effects of Hyperbaric Oxygen Therapy on Acute Thermal Burns

Conditions
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Acute Thermal Burns

Intervention / Treatment
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* Procedure: Hyperbaric Oxygen Therapy
* Other: Standard care


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hyperbaric Oxygen Therapy<br>2 HBOT treatments | Procedure: Hyperbaric Oxygen Therapy<br>* 2 sessions of HBOT ( HDMC 14)<br>|
| Active Comparator: 2<br>Standard care and treatment | Other: Standard care<br>* Patient will undergo standard care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Burns conversion |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bacteriology culture and immunology markers |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Thermal Burns, Hyperbaric Oxygen Therapy, Burns conversion