To Study the Effect of β-glucans on Wound Healing

Burns Clinical Trial

Official title:

To Study the Effect of β-glucans on Wound Healing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02078128
• Other study ID #: 201105013MB
• Status: Completed
• Phase: N/A
• First received: September 17, 2012
• Last updated: March 3, 2014
• Start date: July 2011
• Est. completion date: February 2013

Study information

• Verified date: March 2014
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 2013
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Burns

Intervention

Dietary Supplement:
• oral beta-glucans
30 mg/kg, oral every day until wound healed completes or unacceptable toxicity develops.

Drug:
• oral sugar powder
30 mg/kg, oral every day until wound healed completes or unacceptable toxicity develops.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wound healing percentage	record data by taking picture	every Monday and Thuresday for the duration of hospital stay, an expected average of 3 weeks	Yes