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

Phase 1

• Conditions: Acute Thermal Burns
• Interventions: Procedure: Hyperbaric Oxygen Therapy; Other: Standard care

• Registration Number: NCT00824551
• Lead Sponsor: Singapore General Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2008-12
• Study Start: 2009-01
• Study First Submitted: 2009-01-15
• Study First Submitted QC: 2009-01-15
• Last Update Submitted: 2009-01-15
• Study First Posted: 2009-01-16
• Last Update Posted: 2009-01-16
• Primary Completion: 2010-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hyperbaric Oxygen Therapy	Hyperbaric Oxygen Therapy	2 HBOT treatments
2	Standard care	Standard care and treatment

Primary Outcome Measures

Name	Time	Method
Burns conversion	2 years

Secondary Outcome Measures

Name	Time	Method
Bacteriology culture and immunology markers	2 years

Trial Locations

Locations (1)

Singapore General Hospital; 🇸🇬 Singapore, Singapore