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

NCT00824551 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2009-01-16

No results posted yet for this study

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

Interventions

PROCEDURE

Hyperbaric Oxygen Therapy

2 sessions of HBOT ( HDMC 14)

OTHER

Standard care

Patient will undergo standard care

Sponsors & Collaborators

  • Singapore General Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2010-12-31

Countries

  • Singapore

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00824551 on ClinicalTrials.gov