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

NCT ID: NCT00824551

Last Updated: 2009-01-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31

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.

Conditions

Acute Thermal Burns

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Hyperbaric Oxygen Therapy

2 HBOT treatments

Group Type: EXPERIMENTAL

Hyperbaric Oxygen Therapy

Intervention Type: PROCEDURE

2 sessions of HBOT ( HDMC 14)

2

Standard care and treatment

Group Type: ACTIVE_COMPARATOR

Standard care

Intervention Type: OTHER

Patient will undergo standard care

Interventions

Hyperbaric Oxygen Therapy

2 sessions of HBOT ( HDMC 14)

Intervention Type: PROCEDURE

Standard care

Patient will undergo standard care

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Singapore General Hospital

OTHER

Sponsor Role: lead

Responsible Party

republic of singapore navy and singapore general hospital

Locations

Singapore General Hospital

Singapore, , Singapore

Site Status: RECRUITING

Countries

Singapore

Central Contacts

chong si jack

Role: CONTACT

chong_si_jack@hotmail.com

65-91467592

Facility Contacts

chong si jack, mbbs,m.med

Role: primary

chong_si_jack@hotmail.com

65-91467592

Other Identifiers

1501

Identifier Type: -

Identifier Source: org_study_id