- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00824551
The Effects of Hyperbaric Oxygen Therapy (HBOT) on Acute Thermal Burns
January 15, 2009 updated by: Singapore General Hospital
The Effects of Hyperbaric Oxygen Therapy on Acute Thermal Burns
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
80
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: chong si jack
- Phone Number: 65-91467592
- Email: chong_si_jack@hotmail.com
Study Locations
-
-
-
Singapore, Singapore, 169608
- Recruiting
- Singapore General Hospital
-
Contact:
- chong si jack, mbbs,m.med
- Phone Number: 65-91467592
- Email: chong_si_jack@hotmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 58 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Hyperbaric Oxygen Therapy
2 HBOT treatments
|
2 sessions of HBOT ( HDMC 14)
|
Active Comparator: 2
Standard care and treatment
|
Patient will undergo standard care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Burns conversion
Time Frame: 2 years
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Bacteriology culture and immunology markers
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2009
Primary Completion (Anticipated)
December 1, 2010
Study Registration Dates
First Submitted
January 15, 2009
First Submitted That Met QC Criteria
January 15, 2009
First Posted (Estimate)
January 16, 2009
Study Record Updates
Last Update Posted (Estimate)
January 16, 2009
Last Update Submitted That Met QC Criteria
January 15, 2009
Last Verified
December 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1501 (CSL Behring)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Acute Thermal Burns
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Cairo UniversityCompleted
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Cytori TherapeuticsCompleted
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MediWound LtdCompletedThermal BurnsUnited States, Israel, Belgium, Czechia, Georgia, Germany, Italy, Romania
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Arteriocyte, Inc.Department of Health and Human ServicesUnknownAcute Deep Partial Thickness Thermal BurnsUnited States
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University of FloridaTerminated
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Stratatech, a Mallinckrodt CompanyActive, not recruitingFull Thickness Thermal BurnUnited States
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Regeneron PharmaceuticalsSanofiWithdrawnThermal Injury PainUnited States
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HealthPartners InstituteCompleted
-
Stratatech, a Mallinckrodt CompanyCompleted
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