The Effects of Hyperbaric Oxygen Therapy (HBOT) on Acute Thermal Burns
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|ClinicalTrials.gov Identifier: NCT00824551|
Recruitment Status : Unknown
Verified December 2008 by Singapore General Hospital.
Recruitment status was: Recruiting
First Posted : January 16, 2009
Last Update Posted : January 16, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Acute Thermal Burns||Procedure: Hyperbaric Oxygen Therapy Other: Standard care||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||The Effects of Hyperbaric Oxygen Therapy on Acute Thermal Burns|
|Study Start Date :||January 2009|
|Estimated Primary Completion Date :||December 2010|
Experimental: Hyperbaric Oxygen Therapy
2 HBOT treatments
Procedure: Hyperbaric Oxygen Therapy
2 sessions of HBOT ( HDMC 14)
Active Comparator: 2
Standard care and treatment
Other: Standard care
Patient will undergo standard care
- Burns conversion [ Time Frame: 2 years ]
- Bacteriology culture and immunology markers [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00824551
|Contact: chong si email@example.com|
|Singapore General Hospital||Recruiting|
|Singapore, Singapore, 169608|
|Contact: chong si jack , mbbs,m.med 65-91467592 firstname.lastname@example.org|