To Study the Healing Effect of Silver Impregnated Activated Carbon Fiber Wound Dressing on Deep Dermal Burn
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.
To investigate wound healing effects of BCT Antimicrobial Dressing on deep dermal burn.
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.
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 Design:||Allocation: Randomized
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|
- The healing rate [ Time Frame: 21 days ]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)
- The healing percentage [ Time Frame: 21 days ]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 ]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.
|Study Start Date:||May 2012|
|Study Completion Date:||March 2014|
|Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Control
Flamazine is applied on the wound in the control group instead and then covered with sterile gauze
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01598493
|Burn Center, Department of Surgery, National Taiwan University Hospital|
|Taipei city, Taiwan, 10002|
|Principal Investigator:||Eng Kean Yeong, MD||National Taiwan University Hospital|