To Study the Effect of β-glucans on Wound Healing

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

Study Overview

• Status: Completed
• Conditions: Burns
• Intervention / Treatment: Drug: oral sugar powder; Dietary supplement: oral beta-glucans

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: oral beta-glucans; Daily give kg per day to 30 mg of β-glucan (30mg/kg/day), taking to the wound healed.	Drug: oral sugar powder; 30 mg/kg, oral every day until wound healed completes or unacceptable toxicity develops.; Other Names: placebo, sugar, glucose
Placebo Comparator: 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.	Dietary supplement: oral beta-glucans; 30 mg/kg, oral every day until wound healed completes or unacceptable toxicity develops.; Other Names: D-glucose polysaccharides

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound healing percentage	record data by taking picture	every Monday and Thuresday for the duration of hospital stay, an expected average of 3 weeks

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Eng Kean Yeong, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: September 17, 2012
• First Submitted That Met QC Criteria: March 3, 2014
• First Posted (Estimate): March 5, 2014

Study Record Updates

• Last Update Posted (Estimate): March 5, 2014
• Last Update Submitted That Met QC Criteria: March 3, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: burn, wound healing, skin graft
• Other Study ID Numbers: 201105013MB