Status:
COMPLETED
The Clinical Application and Efficacy Verification of an Innovative Carbon Fiber Dressing
Lead Sponsor:
Bio-medical Carbon Technology Co., Ltd.
Collaborating Sponsors:
China Medical University Hospital
Conditions:
Wounds
Eligibility:
All Genders
20-85 years
Phase:
NA
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 acti...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01921725
Start Date
May 1 2013
Last Update
August 13 2013
Active Locations (2)
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1
Division of Plastic Surgery, Department of Surgery, China Medical University Hospital
Taichung, Taiwan, 40447
2
Division of Plastic Surgery, Department of Surgery, China Medical University Beigang Hospital
Yunlin County, Taiwan, 65152