To Study the Healing Effect of Silver Impregnated Activated Carbon Fiber Wound Dressing on Deep Dermal Burn

Background:

Bio-medical Carbon Technology (BCT) Antimicrobial Dressing, a novel advanced wound dressing invented by Bio-medical Carbon Technology Co., Ltd., Taiwan, consists principally of activated carbon fiber impregnated with silver particles. The highly porous nature and the large specific surface area of activated carbon fiber provide a tremendous adsorptive capacity for toxins, wound degradation products, and odors. Furthermore, far infrared ray emitted from activated carbon fiber accelerates blood circulation to stimulate tissue regeneration. Silver ions efficiently eliminate a broad spectrum of bacteria through penetrating the cell wall of bacteria and denaturing essential proteins. This clinical trial investigates wound healing effects of BCT Antimicrobial Dressing on deep dermal burn patients.

Aim:

To investigate wound healing effects of BCT Antimicrobial Dressing on deep dermal burn.

Methods:

This trial is expected to recruit 30 eligible subjects. After hospitalized patients are diagnosed as deep dermal burn, the procedure of Informed Consent is conducted by the project investigator. As long as the patient agrees to join this clinical trial and signs the Informed Consent, two separate areas of 25 cm2 in the same anatomic site are chosen and distributed to the control and research groups respectively by coin flipping. The wound in the research group is first cleansed with normal saline and then applied with BCT Antimicrobial Dressing and covered by sterile gauze, and dressings will be changed every 3 days (counting from the day applied BCT dressings: Day0, 3, 6, 9, 12, 15……etc.) until the wound is healed. Flamazine is applied on the wound in the control group instead and then covered with sterile gauze, and the frequency of dressing change is daily until the wound is recovered. The healed and non-healed area of wound is recorded and photographed every 3 days, and the wound color and infection are also evaluated. On Day 12 and Day 21, compare the ratio of healing and non-healed areas in the control and research groups, and the ending point is set on the 21st day.

Statistics Analysis:

Paired Student's t-test will be performed to analyze the clinical data by comparing the difference of the healing percentage, the healing rate, the infection rate, and the frequency of dressing change. It is statistically significant when P<0.05.

Study Overview

• Status: Completed
• Conditions: Burns
• Intervention / Treatment: Drug: Flamazine; Device: BCT Antimicrobial Dressing

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

Contacts and Locations

Study Locations

• Taiwan
  • Taipei city, Taiwan, 10002
    • Burn Center, Department of Surgery, National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• The total burn area is between 5% to 30%
• Male/Female of any race aged between 20 - 80 years old
• Non taking any medicine containing steroid
• No allergy to activated carbon fiber and silver
• No history of cardiovascular diseases, diabetes mellitus, immune system-related diseases, hepatic disease, hematic diseases, renal diseases, and cancer

Exclusion Criteria:

• The total burn area is less than 5% or larger than 30%
• Male/Female of any race aged younger than 20 years old or older than 80 years old
• Taking any medicine containing steroid
• Allergy to activated carbon fiber and silver
• With history of cardiovascular diseases, diabetes mellitus, immune system-related diseases, hepatic disease, hematic diseases, renal diseases, and cancer

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; Flamazine is applied on the wound in the control group instead and then covered with sterile gauze	Drug: Flamazine; Silver sulfadiazine cream
Experimental: BCT Antimicrobial Dressing; The wound in the experimental group is first cleansed with normal saline and then applied with BCT Antimicrobial Dressing and covered by sterile gauze, and dressings will be changed every 3 days.	Device: BCT Antimicrobial Dressing; Activated carbon fiber impregnated with silver particles

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The healing rate	Photograph of wounds are taken on the specific day (Day0, 3, 6, 9……etc.) and pictures are imported to image-analyzing software for the calculation of wound area. And the number of wound area is then transformed to the healing percentage. Healing Rate= healed area/the number of healing days (cm2/day)	21 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The healing percentage	Photograph of wounds are taken on the specific day (Day0, 3, 6, 9……etc.) and pictures are imported to image-analyzing software for the calculation of wound area. And the number of wound area is then transformed to the healing rate. Healing Percentagen =[(the initial wound area-wound area measured on Dayn)/the initial wound area]x100%. N means the number of days counting from the first day initiating this clinical trial.	21 days
The size of skin-grafting area	Subjects of this clinical trial will be evaluated for wound healing and diagnosed the requirement of skin grafting on Day12 by PI. If skin grafting is obligate, PI will also estimate and record the size of skin-grafting area.	21 days

Collaborators and Investigators

• Sponsor: Bio-medical Carbon Technology Co., Ltd.
• Collaborators: National Taiwan University Hospital
• Investigators: Principal Investigator: Eng Kean Yeong, MD, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: May 9, 2012
• First Submitted That Met QC Criteria: May 13, 2012
• First Posted (Estimate): May 15, 2012

Study Record Updates

• Last Update Posted (Actual): July 13, 2017
• Last Update Submitted That Met QC Criteria: July 12, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Wound Healing; Burns
• Additional Relevant MeSH Terms: Wounds and Injuries; Burns; Anti-Infective Agents, Local; Anti-Bacterial Agents; Anti-Infective Agents; Silver Sulfadiazine
• Other Study ID Numbers: 201201003DSA