BurnsPhase 1NCT00283426
Efficacy and Safety Study of Soluble Beta-1,3/1,6-Glucan in Thermal Burns
A Phase 1 study testing Soluble beta-1,3/1,6-glucan in people with Burns, run by Biotec Pharmacon ASA at 1 site in Norway.
Trial summary
The purpose of this study is to determine whether soluble beta-1,3/1,6-glucan is an effective and safe treatment of thermal burns and non-injured skin where skin grafts are harvested. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burns
- What is being tested?
- Soluble beta-1,3/1,6-glucan
- How many people
- 10 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2006to Mar 2007
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age >= 18 years
- written informed consent
- Group A - patients with thermal burns
- partial thickness burns (2nd degree) requiring non-surgical primary treatment
- primarily 5-15% TBSA burns, but burn patients with injury size from 1 to 40% TBSA may be included
- or
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- Group B - patients with thermal burns
- non-grafted partial thickness burns (2nd degree) in patients requiring autotransplantation in the early phase
- primarily 5-15% TBSA burns, but burn patients with injury size from 1 to 40% TBSA may be included
- or
- Group C - patients with thermal burns
- donor site(s) on the ventral side of the body and limbs in deep partial thickness burns (2nd degree) and/or full thickness burns patients requiring autotransplantation during the first 1-3 weeks after injury
- primarily 5-15% TBSA burns, but burn patients with injury size from 1 to 40% TBSA may be included
Who cannot join
- inhalation injury to airways and lungs
- chemical or high voltage electrical burn
- pregnancy, lactation
- clinical signs or symptoms of acute infection
- any prescription or non-prescription topical medication administered within one week prior to study start
- hematological and clinical/chemical parameteres judged as unacceptable by the investigator
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- donor sites with re-harvesting
- previous treatment with soluble beta-1,3/1,6-glucan
- participation in other clinical studies in the last 4 weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Clinical Feasibility Study to Evaluate Efficacy and Safety of Soluble Beta-1,3/1,6-Glucan in Thermal Burns
The purpose of this study is to determine whether soluble beta-1,3/1,6-glucan is an effective and safe treatment of thermal burns and non-injured skin where skin grafts are harvested.
Hypothesis: Soluble beta-1,3/1,6-glucan will through its immunomodulating activities improve wound healing of thermal burns and non-injured skin where skin grafts are harvested.
Read the detailed description
In severe cases, burn patients commonly exhibit a clinical picture of systemic inflammation with a variety of manifestations ranging from the presence of tachycardia, tachypnea, fever and leukocytosis, and may progress to refractory hypotension. Shock and multiple organ system dysfunction may subsequently occur. Sepsis, caused by infection or bacteremia, is also a common occurrence and a major complication in burn patients.
After cooling the burned area, pain control is important. Local burn wound care starts with cleansing the wound followed by application of topical agents to prevent infection. Such agents may have adverse local or systemic effects and may impede on the wound healing process itself. The use of synthetic or biologic materials for wound covering is becoming increasingly popular, but most of the clinical information about efficacy of such products are anecdotal.
A primary objective in burn care is to have all wounds healed within 1 month. With longer healing periods, there is an increasing likelihood of developing hypertropic scaring and alterations in pigmentation. The development of an effective wound healing agent would therefore be highly beneficial for the suffering patient in terms of decreased healing time and improved cosmetic results.
- Conditions
- Burns
- Being tested
- Soluble beta-1,3/1,6-glucan
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soluble beta-1,3/1,6-glucanDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy parameters:
oedema
bleeding
pain on physical contact
exudation
capillary refill
reepithelialization
rubor
paleness
infectious discharge
smell
adherence of dressing
time since last dressing change
The efficacy parameters will be recorded during regular wound procedures
Secondary outcomes (5)
Safety parameters:
vital signs (heart rate, blood pressure, body temperature)
adverse events
laboratory parameters
The safety parameters will be recorded daily during the first week of treatment and weekly thereafter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2006 (estimated)
- Study startJan 2006
- Study completionMar 2007
Why it stopped: Slow patient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants
Sponsor and investigators
- Lead sponsor
- Biotec Pharmacon ASA
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Tjostolv Lund, Dr.med., Principal investigator, Haukeland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00283426
- Sponsor's protocol ID
- SBG-1-10
- Status last verified
- Mar 2007
- First submitted
- 27 Jan 2006
- Last updated
- 19 Mar 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Clinical Feasibility Study to Evaluate Efficacy and Safety of Soluble Beta-1,3/1,6-Glucan in Thermal Burns
- ClinicalTrials.gov ID
- NCT00283426
- Acronym / sponsor ID
- SBG-1-10
- Conditions
- Burns
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow patient recruitment
- Enrolment
- 10 participants
- Lead sponsor
- Biotec Pharmacon ASAIndustry (pharma, biotech, devices)
- Study start
- Jan 2006
- Study completion
- Mar 2007
- First posted
- 30 Jan 2006 (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 purpose of this study is to determine whether soluble beta-1,3/1,6-glucan is an effective and safe treatment of thermal burns and non-injured skin where skin grafts are harvested.
Hypothesis: Soluble beta-1,3/1,6-glucan will through its immunomodulating activities improve wound healing of thermal burns and non-injured skin where skin grafts are harvested.
Detailed description
In severe cases, burn patients commonly exhibit a clinical picture of systemic inflammation with a variety of manifestations ranging from the presence of tachycardia, tachypnea, fever and leukocytosis, and may progress to refractory hypotension. Shock and multiple organ system dysfunction may subsequently occur. Sepsis, caused by infection or bacteremia, is also a common occurrence and a major complication in burn patients.
After cooling the burned area, pain control is important. Local burn wound care starts with cleansing the wound followed by application of topical agents to prevent infection. Such agents may have adverse local or systemic effects and may impede on the wound healing process itself. The use of synthetic or biologic materials for wound covering is becoming increasingly popular, but most of the clinical information about efficacy of such products are anecdotal.
A primary objective in burn care is to have all wounds healed within 1 month. With longer healing periods, there is an increasing likelihood of developing hypertropic scaring and alterations in pigmentation. The development of an effective wound healing agent would therefore be highly beneficial for the suffering patient in terms of decreased healing time and improved cosmetic results.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- age >= 18 years
- written informed consent
- Group A - patients with thermal burns
- partial thickness burns (2nd degree) requiring non-surgical primary treatment
- primarily 5-15% TBSA burns, but burn patients with injury size from 1 to 40% TBSA may be included
Key exclusion criteria (9 listed)
- inhalation injury to airways and lungs
- chemical or high voltage electrical burn
- pregnancy, lactation
- clinical signs or symptoms of acute infection
- any prescription or non-prescription topical medication administered within one week prior to study start
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 |
|---|---|---|
| Soluble beta-1,3/1,6-glucan | Drug | – |
Primary outcome
Efficacy parameters:
oedema
bleeding
pain on physical contact
exudation
capillary refill
reepithelialization
rubor
paleness
infectious discharge
smell
adherence of dressing
time since last dressing change
The efficacy parameters will be recorded during regular wound procedures
5 secondary outcomes
Safety parameters:
vital signs (heart rate, blood pressure, body temperature)
adverse events
laboratory parameters
The safety parameters will be recorded daily during the first week of treatment and weekly thereafter
Results and safety
The study was stopped early (reason given: Slow patient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2007.
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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.
Tjostolv Lund, Dr.med. principal investigator
Haukeland University Hospital
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 Soluble beta-1,3/1,6-glucan in people with Burns, run by Biotec Pharmacon ASA at 1 site in Norway.
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 13 inclusion and 9 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: stopped early, as of the sponsor's last update on 19 Mar 2007. 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 Norway. 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?
The study was stopped early (reason given: Slow patient recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy parameters:. The study lists 14 primary outcomes in all. 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 19 Mar 2007.