To Study the Effect of β-glucans on Wound Healing

NCT ID: NCT02078128

Last Updated: 2014-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2013-02-28

Brief Summary

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The purpose of this study is to determine the effect of β-glucans on wound healing.

Detailed Description

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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

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Burns

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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oral beta-glucans

Daily give kg per day to 30 mg of β-glucan (30mg/kg/day), taking to the wound healed.

Group Type EXPERIMENTAL

oral sugar powder

Intervention Type DRUG

30 mg/kg, oral every day until wound healed completes or unacceptable toxicity develops.

oral sugar powder

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.

Group Type PLACEBO_COMPARATOR

oral beta-glucans

Intervention Type DIETARY_SUPPLEMENT

30 mg/kg, oral every day until wound healed completes or unacceptable toxicity develops.

Interventions

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oral beta-glucans

30 mg/kg, oral every day until wound healed completes or unacceptable toxicity develops.

Intervention Type DIETARY_SUPPLEMENT

oral sugar powder

30 mg/kg, oral every day until wound healed completes or unacceptable toxicity develops.

Intervention Type DRUG

Other Intervention Names

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D-glucose polysaccharides placebo, sugar, glucose

Eligibility Criteria

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Inclusion Criteria

1. Total burn area under 20%, two to three degree burn and need skin-grafting.
2. Subjects don't have other diseases.
3. Subjects' age between 20 to 60.

Exclusion Criteria

1. Subjects with hypersensitivity.
2. Subjects with Autoimmune disease.
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eng Kean Yeong

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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201105013MB

Identifier Type: -

Identifier Source: org_study_id

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