To Study the Healing Effect of Silver Impregnated Activated Carbon Fiber Wound Dressing on Deep Dermal Burn
Status:
Completed
Trial end date:
2014-03-01
Target enrollment:
Participant gender:
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.