To Study the Healing Effect of Silver Impregnated Activated Carbon Fiber Wound Dressing on Deep Dermal Burn
Condition: Burns
MeSH terms: Burns
Study type: Interventional

Summary: 
      Background:

      Bio-medical Carbon Technology (BCT) Antimicrobial Dressing, a novel advanced wound dressing
      invented by Bio-medical Carbon Technology Co., Ltd., Taiwan, consists principally of
      activated carbon fiber impregnated with silver particles. The highly porous nature and the
      large specific surface area of activated carbon fiber provide a tremendous adsorptive
      capacity for toxins, wound degradation products, and odors. Furthermore, far infrared ray
      emitted from activated carbon fiber accelerates blood circulation to stimulate tissue
      regeneration. Silver ions efficiently eliminate a broad spectrum of bacteria through
      penetrating the cell wall of bacteria and denaturing essential proteins. This clinical trial
      investigates wound healing effects of BCT Antimicrobial Dressing on deep dermal burn
      patients.

      Aim:

      To investigate wound healing effects of BCT Antimicrobial Dressing on deep dermal burn.

      Methods:

      This trial is expected to recruit 30 eligible subjects. After hospitalized patients are
      diagnosed as deep dermal burn, the procedure of Informed Consent is conducted by the project
      investigator. As long as the patient agrees to join this clinical trial and signs the
      Informed Consent, two separate areas of 25 cm2 in the same anatomic site are chosen and
      distributed to the control and research groups respectively by coin flipping. The wound in
      the research group is first cleansed with normal saline and then applied with BCT
      Antimicrobial Dressing and covered by sterile gauze, and dressings will be changed every 3
      days (counting from the day applied BCT dressings: Day0, 3, 6, 9, 12, 15……etc.) until the
      wound is healed. Flamazine is applied on the wound in the control group instead and then
      covered with sterile gauze, and the frequency of dressing change is daily until the wound is
      recovered. The healed and non-healed area of wound is recorded and photographed every 3 days,
      and the wound color and infection are also evaluated. On Day 12 and Day 21, compare the ratio
      of healing and non-healed areas in the control and research groups, and the ending point is
      set on the 21st day.

      Statistics Analysis:

      Paired Student's t-test will be performed to analyze the clinical data by comparing the
      difference of the healing percentage, the healing rate, the infection rate, and the frequency
      of dressing change. It is statistically significant when P<0.05.
    


Intervention name(s): BCT Antimicrobial Dressing; Flamazine
Intervention type(s): Device; Drug
Intervention description(s): Activated carbon fiber impregnated with silver particles; Silver sulfadiazine cream
Intervention MeSH terms: Anti-Infective Agents; Silver Sulfadiazine; Anti-Bacterial Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Burns; Wound Healing