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

NCT01921725 | Completed

• 1 other identifier: DMR101-IRB2-156
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Wounds

Keywords

wound healing; carbon

Outcome Measures

Primary Outcomes (1)

• The healing percentage

  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.

  one month

Secondary Outcomes (1)

• The healing rate

  one month

Other Outcomes (2)

• Antibiotics usage

  one month

• Infection rate

  one month

Study Arms (1)

Hydrophilic-based dressing (KoCarbonTM)

EXPERIMENTAL

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)

Interventions

hydrophilic-based dressing (KoCarbonTM) DEVICE

"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.

Also known as: "BCT" hydrophilic wound dressing

Hydrophilic-based dressing (KoCarbonTM)

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bio-medical Carbon Technology Co., Ltd.: lead
• China Medical University Hospital: collaborator

Study Sites (2)

Division of Plastic Surgery, Department of Surgery, China Medical University Hospital

Taichung, 40447, Taiwan

Location

Division of Plastic Surgery, Department of Surgery, China Medical University Beigang Hospital

Yunlin County, 65152, Taiwan

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Tzong-Shiun Li, M.D., Ph.D.

  Division of Plastic Surgery, Department of Surgery, China Medical University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2013
• First Posted: August 13, 2013
• Study Start: May 1, 2013
• Primary Completion: August 1, 2013
• Last Updated: August 13, 2013

Record last verified: 2013-08

Locations

TW (2)