BurnsNCT02078128
To Study the Effect of β-glucans on Wound Healing
A study testing oral beta-glucans and oral sugar powder in people with Burns, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The purpose of this study is to determine the effect of β-glucans on wound healing. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Burns
- What is being tested?
- oral beta-glucans and oral sugar powder
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- Jul 2011to Feb 2013
- Phase
- Interventional
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Total burn area under 20%, two to three degree burn and need skin-grafting.
- Subjects don't have other diseases.
- Subjects' age between 20 to 60.
Who cannot join
- Subjects with hypersensitivity.
- Subjects with Autoimmune disease.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine the effect of β-glucans on wound healing.
Read the detailed description
The structure of βeta-glucan (β-glucans) is a pathogen associated molecular patterns (pathogen-associated molecular patterns, PAMPs), widely present in the cell walls of plants, bacteria, yeasts, fungi, mushrooms and algae. Modern has been reported in the literature that β-glucan can enhance the immune system of animals, and to enhance the function of the animal against bacterial, fungal and viral infections, and cancer.In this study, the use of β-glucan to enhance the biological characteristics of the non-specific immunity, to explore the impact of postoperative patients with wound healing and infection rates.The observation of the healing process to take the Leather District wounds (5 ~ 200 cm2). The experiments were carried out for 18 months, were observed record the following three: (1) the rate of wound healing, (2) The rate of infection assessment: record length of time and the point in time at all levels of antibiotic use also observe the wound change (redness, swelling, heat, pain).(3) days of hospitalization, and spend statistics. Using unpaired student's t-test analysis, group data whether the differences between groups of experimental data. represents a statistically significant when p <0.05.
- Conditions
- Burns
- Being tested
- oral beta-glucans, oral sugar powder
- Keywords
- burn, wound healing, skin graft
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral beta-glucansDietary supplement
Also called D-glucose polysaccharides
30 mg/kg, oral every day until wound healed completes or unacceptable toxicity develops.
oral sugar powderDrug
Also called placebo, sugar, glucose
30 mg/kg, oral every day until wound healed completes or unacceptable toxicity develops.
| Study group | Role | What they receive |
|---|---|---|
| oral beta-glucans | Experimental | Daily give kg per day to 30 mg of β-glucan (30mg/kg/day), taking to the wound healed. Receives: Drug: oral sugar powder |
| oral sugar powder | Placebo comparator | control group, daily give and the glucose powder 30 mg per kilogram of body weight (30mg/kg/day) a day, taking to the wound healed. Receives: Dietary Supplement: oral beta-glucans |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound healing percentage
record data by taking picture
Measured: every Monday and Thuresday for the duration of hospital stay, an expected average of 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2014 (estimated)
- Study startJul 2011
- Primary completionAug 2011
- Study completionFeb 2013
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.
- More trials run by National Taiwan University 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eng Kean Yeong, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02078128
- Sponsor's protocol ID
- 201105013MB
- Status last verified
- Mar 2014
- First submitted
- 17 Sep 2012
- Last updated
- 5 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Study the Effect of β-glucans on Wound Healing
- ClinicalTrials.gov ID
- NCT02078128
- Acronym / sponsor ID
- 201105013MB
- Conditions
- Burns
- Keywords
- burn, wound healing, skin graft
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 5 Mar 2014 (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 the effect of β-glucans on wound healing.
Detailed description
The structure of βeta-glucan (β-glucans) is a pathogen associated molecular patterns (pathogen-associated molecular patterns, PAMPs), widely present in the cell walls of plants, bacteria, yeasts, fungi, mushrooms and algae. Modern has been reported in the literature that β-glucan can enhance the immune system of animals, and to enhance the function of the animal against bacterial, fungal and viral infections, and cancer.In this study, the use of β-glucan to enhance the biological characteristics of the non-specific immunity, to explore the impact of postoperative patients with wound healing and infection rates.The observation of the healing process to take the Leather District wounds (5 ~ 200 cm2). The experiments were carried out for 18 months, were observed record the following three: (1) the rate of wound healing, (2) The rate of infection assessment: record length of time and the point in time at all levels of antibiotic use also observe the wound change (redness, swelling, heat, pain).(3) days of hospitalization, and spend statistics. Using unpaired student's t-test analysis, group data whether the differences between groups of experimental data. represents a statistically significant when p <0.05.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oral beta-glucans | Experimental | Drug: oral sugar powderDaily give kg per day to 30 mg of β-glucan (30mg/kg/day), taking to the wound healed. |
| oral sugar powder | Placebo comparator | Dietary Supplement: oral beta-glucanscontrol group, daily give and the glucose powder 30 mg per kilogram of body weight (30mg/kg/day) a day, taking to the wound healed. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Total burn area under 20%, two to three degree burn and need skin-grafting.
- Subjects don't have other diseases.
- Subjects' age between 20 to 60.
Key exclusion criteria (2 listed)
- Subjects with hypersensitivity.
- Subjects with Autoimmune disease.
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 |
|---|---|---|
| oral beta-glucansAlso: D-glucose polysaccharides30 mg/kg, oral every day until wound healed completes or unacceptable toxicity develops. | Dietary supplement | oral sugar powder |
| oral sugar powderAlso: placebo, sugar, glucose30 mg/kg, oral every day until wound healed completes or unacceptable toxicity develops. | Drug | oral beta-glucans |
Primary outcome
Wound healing percentage
Time frame: every Monday and Thuresday for the duration of hospital stay, an expected average of 3 weeks
record data by taking picture
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2014.
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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.
Eng Kean Yeong principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oral beta-glucans and oral sugar powder in people with Burns, run by National Taiwan University Hospital at 1 site in Taiwan.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 5 Mar 2014. 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 Taiwan. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Wound healing percentage (time frame: every Monday and Thuresday for the duration of hospital stay, an expected average of 3 weeks). 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 5 Mar 2014.