The Clinical Application and Efficacy Verification of an Innovative Carbon Fiber Dressing
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|ClinicalTrials.gov Identifier: NCT01921725|
Recruitment Status : Completed
First Posted : August 13, 2013
Last Update Posted : August 13, 2013
The research uses hydrophilic-based dressing (KoCarbonTM) which is developed by Medical Technology Company Limited (Bio-medical Carbon Technology; BCT) to investigate the wound healing effects of activated-carbon-fiber-based wound dressing on different types of wounds.The dressing is composed by three layers. The first layer is a material of polyethylene terephthalate (PET) weave which is great breathable; Second layer, the activated carbon fiber cloth, is as the absorption of excess tissue fluid, bacteria and contaminations. It reduces the smell of wound and restrains the development of bacteria. In addition, activated carbon has features of far-infrared and anion, which promote blood circulation, speed up metabolism and shorten the time of wound healing. The third layer is a polyethlene (PE) film, which touches the wound surface and provides the anti-adhesion effects.
The aim of this study is to investigate how the application of the dressing affects the wound healing conditions on four different types of wounds, including general traumatic wounds, elective surgery wound, diabetes foot ulcer (level 2) and chronic wounds. Due to the characteristics of great fluid absorption and far-infrared features, the hydrophilic-based dressing (KoCarbonTM) is expected to work perfectly on improving the wound repair conditions.
|Condition or disease||Intervention/treatment||Phase|
|Wounds||Device: hydrophilic-based dressing (KoCarbonTM)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Clinical Application and Efficacy Verification of an Innovative Carbon Fiber Dressing|
|Study Start Date :||May 2013|
|Actual Primary Completion Date :||August 2013|
Experimental: Hydrophilic-based dressing (KoCarbonTM)
The wound is first cleansed with normal saline, and then applied with hydrophilic-based dressing (KoCarbonTM) and covered by sterile gauze. The frequency of dressing chang is depend on the amount of exudate.
Device: hydrophilic-based dressing (KoCarbonTM)
"BCT" Hydrophilic Wound Dressing consists of PET non-woven, activated carbon fiber (ACF) cloth and PE film. The PET non-woven is vapor permeable to allow air exchange for the wound. The absorbent ACF absorbs exudate, bacteria and odor to create an effective barrier. Furthermore, far infrared ray (FIR) emitted from ACF accelerates blood circulation and metabolism to reduce healing period. The PE film helps to minimize wound trauma at dressing changes.
Other Name: "BCT" hydrophilic wound dressing
- The healing percentage [ Time Frame: one month ]Photograph of wounds are taken on each visit 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 Percentage N =[(the initial wound area-wound area measured on Day N)/the initial wound area]x100%. N means the number of days counting from the first day initiating this clinical trial.
- The healing rate [ Time Frame: one month ]Photograph of wounds are taken on each visit 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 Rate= healed area/the number of healing days (cm2/day)
- Antibiotics usage [ Time Frame: one month ]The dose and frequency of antibiotics usage of each subject during the whole trial will be recorded.
- Infection rate [ Time Frame: one month ]The occurrence rate of infection among all the subjects will be calculated.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01921725
|Division of Plastic Surgery, Department of Surgery, China Medical University Hospital|
|Taichung, Taiwan, 40447|
|Division of Plastic Surgery, Department of Surgery, China Medical University Beigang Hospital|
|Yunlin County, Taiwan, 65152|
|Principal Investigator:||Tzong-Shiun Li, M.D., Ph.D.||Division of Plastic Surgery, Department of Surgery, China Medical University Hospital|