Clinical trial NCT01921725: The Clinical Application and Efficacy Verification of an Innovative Carbon Fiber Dressing
Official title: The Clinical Application and Efficacy Verification of an Innovative Carbon Fiber Dressing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wounds
Keywords: wound healing
carbon
Lead sponsor: Bio-medical Carbon Technology Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: China Medical University Hospital
First posted: 2013-08-13
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Male/Female of any race aged between 20 - 85 years old
* The subject is willing and able to understand, sign and date the study Informed Consent
* The subject is able to adhere to the scheduled visits regimen
* General traumatic wounds: wound length is less than 20 cm, area less than 100 cm2, and depth less than 0.5 cm
* Elective surgery wound: wound length less than 20 cm, and apply BCT KoCarbon® Hydrophilic Wound Dressing immediately after surgery
* Diabetes foot ulcer (level 2): wound area is between 0.5 cm x 0.5 cm - 5 cm x 5 cm
* Chronic wounds: failed to heal for more than 1 month and wound area is between 0.5 cm x 0.5 cm - 10 cm x 10 cm

Exclusion Criteria:

* Male/Female of any race aged younger than 20 years old or older than 85 years old
* Allergy to activated carbon fiber
* Patients was participating in another clinical trial less than 30 days before participation in this trial
* Any systemic or local active dermatological disease that might interfere with the evaluation of the surgical site such as eczema, psoriasis, skin cancer, scleroderma, chronic urticarial
* Taking any medicine containing steroid in the last 3 months
* With history of cardiovascular diseases, diabetes mellitus, immune system-related diseases, hepatic disease, hematic diseases, renal diseases, and cancer
* Pregnancy
* Severe malnutrition
* fistula or tunnel wounds
* General traumatic wounds: already been infected, or have accepted other treatments for more than 1 week
* Elective surgery wound: already been infected, or delayed suture
* Diabetes foot ulcer (level 2): combined with necrotizing fasciitis or bone and tendon exposure
* Chronic wounds: combined with necrotizing fasciitis or bone and tendon exposure

Primary outcomes:
measure: The healing percentage
timeFrame: one month
Secondary outcomes:
measure: The healing rate
timeFrame: one month
Other outcomes:
measure: Antibiotics usage
timeFrame: one month
measure: Infection rate
timeFrame: one month
Locations:
city: Taichung
country: Taiwan
facility: Division of Plastic Surgery, Department of Surgery, China Medical University Hospital
city: Yunlin County
country: Taiwan
facility: Division of Plastic Surgery, Department of Surgery, China Medical University Beigang Hospital
Study officials:
affiliation: Division of Plastic Surgery, Department of Surgery, China Medical University Hospital
name: Tzong-Shiun Li, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: