To Study the Healing Effect of Silver Impregnated Activated Carbon Fiber Wound Dressing on Deep Dermal Burn
1 other identifier
interventional
30
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2012
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 9, 2012
CompletedFirst Posted
Study publicly available on registry
May 15, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2014
CompletedJuly 13, 2017
July 1, 2017
1.8 years
May 9, 2012
July 12, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
The healing percentage
21 days
The size of skin-grafting area
21 days
Study Arms (2)
Control
ACTIVE COMPARATORFlamazine is applied on the wound in the control group instead and then covered with sterile gauze
BCT Antimicrobial Dressing
EXPERIMENTALThe 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.
Interventions
Activated carbon fiber impregnated with silver particles
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Burn Center, Department of Surgery, National Taiwan University Hospital
Taipei, 10002, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eng Kean Yeong, MD
National Taiwan University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 9, 2012
First Posted
May 15, 2012
Study Start
May 1, 2012
Primary Completion
March 1, 2014
Study Completion
March 1, 2014
Last Updated
July 13, 2017
Record last verified: 2017-07