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

Wounds Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01921725
• Other study ID #: DMR101-IRB2-156
• Status: Completed
• Phase: N/A
• First received: August 9, 2013
• Last updated: August 9, 2013
• Start date: May 2013

Study information

• Verified date: August 2013
• Source: Bio-medical Carbon Technology Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of HealthTaiwan : Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 85 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Wounds

Intervention

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.

Locations

Country	Name	City	State
Taiwan	Division of Plastic Surgery, Department of Surgery, China Medical University Hospital	Taichung
Taiwan	Division of Plastic Surgery, Department of Surgery, China Medical University Beigang Hospital	Yunlin County

Sponsors (2)

Lead Sponsor	Collaborator
Bio-medical Carbon Technology Co., Ltd.	China Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Antibiotics usage	The dose and frequency of antibiotics usage of each subject during the whole trial will be recorded.	one month	No
Other	Infection rate	The occurrence rate of infection among all the subjects will be calculated.	one month	No
Primary	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	No
Secondary	The healing rate	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)	one month	No