Acute Thermal BurnsPhase 1NCT00824551
The Effects of Hyperbaric Oxygen Therapy (HBOT) on Acute Thermal Burns
A Phase 1 study testing Hyperbaric Oxygen Therapy in people with Acute Thermal Burns, run by Singapore General Hospital at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Acute Thermal Burns
- What is being tested?
- Hyperbaric Oxygen Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSingapore
- Study dates
- Jan 2009to Dec 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
Singapore General Hospital
Singapore, 169608
chong si jack, mbbs,m.med, 65-91467592, chong_si_jack@hotmail.com
About this study
Official title: 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.
- Conditions
- Acute Thermal Burns
- Being tested
- Hyperbaric Oxygen Therapy, Standard care
- Keywords
- Acute Thermal Burns, Hyperbaric Oxygen Therapy, Burns conversion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric Oxygen TherapyProcedure or surgery
2 sessions of HBOT ( HDMC 14)
Standard careOther
Patient will undergo standard care
| Study group | Role | What they receive |
|---|---|---|
| Hyperbaric Oxygen Therapy | Experimental | 2 HBOT treatments Receives: Procedure: Hyperbaric Oxygen Therapy |
| 2 | Active comparator | Standard care and treatment Receives: Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Burns conversion
Measured: 2 years
Secondary outcomes (1)
Bacteriology culture and immunology markers
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Thermal BurnsStudies of the same condition, open and under way.
- More trials run by Singapore General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00824551
- Sponsor's protocol ID
- 1501
- Status last verified
- Dec 2008
- First submitted
- 15 Jan 2009
- Last updated
- 16 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Hyperbaric Oxygen Therapy on Acute Thermal Burns
- ClinicalTrials.gov ID
- NCT00824551
- Acronym / sponsor ID
- 1501
- Conditions
- Acute Thermal Burns
- Keywords
- Acute Thermal Burns, Hyperbaric Oxygen Therapy, Burns conversion
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Dec 2010 (estimated)
- First posted
- 16 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyperbaric Oxygen Therapy | Experimental | Procedure: Hyperbaric Oxygen Therapy2 HBOT treatments |
| 2 | Active comparator | Other: Standard careStandard care and treatment |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperbaric Oxygen Therapy2 sessions of HBOT ( HDMC 14) | Procedure or surgery | Hyperbaric Oxygen Therapy |
| Standard carePatient will undergo standard care | Other | 2 |
Primary outcome
Burns conversion
Time frame: 2 years
1 secondary outcome
Bacteriology culture and immunology markers
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2009.
Related trials for Acute Thermal Burns
Not yet recruitingObservational study
Surgical Critical Care Initiative (SC2i) Tissue and Data Acquisition Protocol (TDAP) in Burn Patients Improving the Robustness and Generalizability of Post-burn Sepsis Prediction With the Post-Burn Sepsis Digital Twin. Group 1
Sepsis, Burn Injury
Not yet recruitingObservational study
TDAP in Burn Patients (Group 2)
Sepsis, Burn Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Hyperbaric Oxygen Therapy in people with Acute Thermal Burns, run by Singapore General Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact chong si jack (65-91467592, chong_si_jack@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Burns conversion (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2009.