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

The Effects of Hyperbaric Oxygen Therapy on Acute Thermal Burns

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00824551
Enrollment
80
Registered
2009-01-16
Start date
2009-01-31
Completion date
Unknown
Last updated
2009-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Thermal Burns

Keywords

Acute Thermal Burns, Hyperbaric Oxygen Therapy, Burns conversion

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.

Interventions

PROCEDUREHyperbaric Oxygen Therapy

2 sessions of HBOT ( HDMC 14)

OTHERStandard care

Patient will undergo standard care

Sponsors

Singapore General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
21 Years to 60 Years
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)

Design outcomes

Primary

MeasureTime frame
Burns conversion2 years

Secondary

MeasureTime frame
Bacteriology culture and immunology markers2 years

Countries

Singapore

Contacts

Primary Contactchong si jack
chong_si_jack@hotmail.com65-91467592

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026