Back to resultsThe Effects of Hyperbaric Oxygen Therapy (HBOT) on Acute Thermal Burns
Primary Purpose
Acute Thermal Burns
Status
Unknown status
Phase
Phase 1
Locations
Singapore
Study Type
Interventional
Intervention
Hyperbaric Oxygen Therapy
Standard care
Sponsored by
About this trial
This is an interventional treatment trial for Acute Thermal Burns focused on measuring Acute Thermal Burns, Hyperbaric Oxygen Therapy, Burns conversion
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)
Sites / Locations
- Singapore General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Hyperbaric Oxygen Therapy
2
Arm Description
2 HBOT treatments
Standard care and treatment
Outcomes
Primary Outcome Measures
Burns conversion
Secondary Outcome Measures
Bacteriology culture and immunology markers
Full Information
NCT ID
NCT00824551
First Posted
January 15, 2009
Last Updated
January 15, 2009
Sponsor
Singapore General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00824551
Brief Title
The Effects of Hyperbaric Oxygen Therapy (HBOT) on Acute Thermal Burns
Official Title
The Effects of Hyperbaric Oxygen Therapy on Acute Thermal Burns
Study Type
Interventional
2. Study Status
Record Verification Date
December 2008
Overall Recruitment Status
Unknown status
Study Start Date
January 2009 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Singapore General Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Thermal Burns
Keywords
Acute Thermal Burns, Hyperbaric Oxygen Therapy, Burns conversion
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hyperbaric Oxygen Therapy
Arm Type
Experimental
Arm Description
2 HBOT treatments
Arm Title
2
Arm Type
Active Comparator
Arm Description
Standard care and treatment
Intervention Type
Procedure
Intervention Name(s)
Hyperbaric Oxygen Therapy
Intervention Description
2 sessions of HBOT ( HDMC 14)
Intervention Type
Other
Intervention Name(s)
Standard care
Intervention Description
Patient will undergo standard care
Primary Outcome Measure Information:
Title
Burns conversion
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Bacteriology culture and immunology markers
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
chong si jack
Phone
65-91467592
Email
chong_si_jack@hotmail.com
Facility Information:
Facility Name
Singapore General Hospital
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
chong si jack, mbbs,m.med
Phone
65-91467592
Email
chong_si_jack@hotmail.com
12. IPD Sharing Statement
Learn more about this trial
The Effects of Hyperbaric Oxygen Therapy (HBOT) on Acute Thermal Burns
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