To Study the Healing Effect of Silver Impregnated Activated Carbon Fiber Wound Dressing on Deep Dermal Burn

Burns Clinical Trial

Official title:

To Study the Healing Effect of Silver Impregnated Activated Carbon Fiber Wound Dressing on Deep Dermal Burn

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01598493
• Other study ID #: 201201003DSA
• Status: Completed
• Phase: N/A
• First received: May 9, 2012
• Last updated: July 12, 2017
• Start date: May 2012
• Est. completion date: March 2014

Study information

• Verified date: July 2017
• Source: Bio-medical Carbon Technology Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• The total burn area is between 5% to 30%

• Male/Female of any race aged between 20 - 80 years old

• Non taking any medicine containing steroid

• No allergy to activated carbon fiber and silver

• No history of cardiovascular diseases, diabetes mellitus, immune system-related diseases, hepatic disease, hematic diseases, renal diseases, and cancer

Exclusion Criteria:

• The total burn area is less than 5% or larger than 30%

• Male/Female of any race aged younger than 20 years old or older than 80 years old

• Taking any medicine containing steroid

• Allergy to activated carbon fiber and silver

• With history of cardiovascular diseases, diabetes mellitus, immune system-related diseases, hepatic disease, hematic diseases, renal diseases, and cancer

Related Conditions & MeSH terms

• Burns

Intervention

Device:
• BCT Antimicrobial Dressing
Activated carbon fiber impregnated with silver particles

Drug:
• Flamazine
Silver sulfadiazine cream

Locations

Country	Name	City	State
Taiwan	Burn Center, Department of Surgery, National Taiwan University Hospital	Taipei city

Sponsors (2)

Lead Sponsor	Collaborator
Bio-medical Carbon Technology Co., Ltd.	National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The healing rate	Photograph of wounds are taken on the specific day (Day0, 3, 6, 9……etc.) 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 Rate= healed area/the number of healing days (cm2/day)	21 days
Secondary	The healing percentage	Photograph of wounds are taken on the specific day (Day0, 3, 6, 9……etc.) 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 Percentagen =[(the initial wound area-wound area measured on Dayn)/the initial wound area]x100%. N means the number of days counting from the first day initiating this clinical trial.	21 days
Secondary	The size of skin-grafting area	Subjects of this clinical trial will be evaluated for wound healing and diagnosed the requirement of skin grafting on Day12 by PI. If skin grafting is obligate, PI will also estimate and record the size of skin-grafting area.	21 days