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

NCT ID: NCT01598493

Last Updated: 2017-07-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2014-03-31

Brief 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.

Conditions

Burns

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control

Flamazine is applied on the wound in the control group instead and then covered with sterile gauze

Group Type: ACTIVE_COMPARATOR

Flamazine

Intervention Type: DRUG

Silver sulfadiazine cream

BCT Antimicrobial Dressing

The wound in the experimental 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.

Group Type: EXPERIMENTAL

BCT Antimicrobial Dressing

Intervention Type: DEVICE

Activated carbon fiber impregnated with silver particles

Interventions

BCT Antimicrobial Dressing

Activated carbon fiber impregnated with silver particles

Intervention Type: DEVICE

Flamazine

Silver sulfadiazine cream

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: collaborator

Bio-medical Carbon Technology Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eng Kean Yeong, MD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

Burn Center, Department of Surgery, National Taiwan University Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

201201003DSA

Identifier Type: -

Identifier Source: org_study_id