The Clinical Application and Efficacy Verification of an Innovative Carbon Fiber Dressing

Bio-medical Carbon Technology

Status: Completed

Conditions: Wounds

Treatments: Device: hydrophilic-based dressing (KoCarbonTM)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01921725

DMR101-IRB2-156

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Hydrophilic-based dressing (KoCarbonTM)

Experimental group

Description:

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.

Treatment:

Device: hydrophilic-based dressing (KoCarbonTM)