NCT00824551

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P75+ for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

January 15, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 16, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Last Updated

January 16, 2009

Status Verified

December 1, 2008

Enrollment Period

1.9 years

First QC Date

January 15, 2009

Last Update Submit

January 15, 2009

Conditions

Acute Thermal Burns

Keywords

Acute Thermal BurnsHyperbaric Oxygen TherapyBurns conversion

Outcome Measures

Primary Outcomes (1)

  • Burns conversion

    2 years

Secondary Outcomes (1)

  • Bacteriology culture and immunology markers

    2 years

Study Arms (2)

Hyperbaric Oxygen Therapy

EXPERIMENTAL

2 HBOT treatments

Procedure: Hyperbaric Oxygen Therapy

2

ACTIVE COMPARATOR

Standard care and treatment

Other: Standard care

Interventions

Hyperbaric Oxygen TherapyPROCEDURE

2 sessions of HBOT ( HDMC 14)

Hyperbaric Oxygen Therapy
Standard careOTHER

Patient will undergo standard care

2

Eligibility Criteria

Age21 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Singapore General Hospital

Singapore, 169608, Singapore

RECRUITING

MeSH Terms

Interventions

Hyperbaric OxygenationStandard of Care

Intervention Hierarchy (Ancestors)

Oxygen Inhalation TherapyRespiratory TherapyTherapeuticsQuality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Central Study Contacts

chong si jack

CONTACT

65-91467592chong_si_jack@hotmail.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 15, 2009

First Posted

January 16, 2009

Study Start

January 1, 2009

Primary Completion

December 1, 2010

Last Updated

January 16, 2009

Record last verified: 2008-12

Locations

SG(1)