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

This study has been completed.
Sponsor:
Collaborator:
National Taiwan University Hospital
Information provided by (Responsible Party):
Bio-medical Carbon Technology Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01598493
First received: May 9, 2012
Last updated: November 4, 2014
Last verified: November 2014
History of Changes
  Purpose

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.


Condition Intervention
Burns
 Device: BCT Antimicrobial Dressing
Drug: Flamazine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: To Study the Healing Effect of Silver Impregnated Activated Carbon Fiber Wound Dressing on Deep Dermal Burn

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bio-medical Carbon Technology Co., Ltd.:

Primary Outcome Measures:
  • The healing rate [ Time Frame: 21 days ] [ Designated as safety issue: No ]
    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)


Secondary Outcome Measures:
  • The healing percentage [ Time Frame: 21 days ] [ Designated as safety issue: No ]
    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.

  • The size of skin-grafting area [ Time Frame: 21 days ] [ Designated as safety issue: No ]
    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.
Enrollment: 30
Study Start Date: May 2012
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility
Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01598493

Locations
Taiwan
Burn Center, Department of Surgery, National Taiwan University Hospital
Taipei city, Taiwan, 10002
Sponsors and Collaborators
Bio-medical Carbon Technology Co., Ltd.
National Taiwan University Hospital
Investigators
Principal Investigator: Eng Kean Yeong, MD National Taiwan University Hospital
  More Information

Responsible Party: Bio-medical Carbon Technology Co., Ltd.
ClinicalTrials.gov Identifier: NCT01598493     History of Changes
Other Study ID Numbers: 201201003DSA 
Study First Received: May 9, 2012
Last Updated: November 4, 2014
Health Authority: Taiwan: Department of Health

Keywords provided by Bio-medical Carbon Technology Co., Ltd.:
Burns
Wound Healing

Additional relevant MeSH terms:
Burns
Wounds and Injuries
Carbon fiber
Anti-Infective Agents
Silver Sulfadiazine
Charcoal
Anti-Infective Agents, Local
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antidotes
Protective Agents

ClinicalTrials.gov processed this record on September 23, 2016