WoundsNCT01921725
The Clinical Application and Efficacy Verification of an Innovative Carbon Fiber Dressing
A study testing hydrophilic-based dressing (KoCarbonTM) in people with Wounds, run by Bio-medical Carbon Technology Co., Ltd. at 2 sites in Taiwan.
Trial 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 activated-carbon-fiber-based wound dressing on different types of wounds.The dressing is composed by three layers. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Wounds
- What is being tested?
- hydrophilic-based dressing (KoCarbonTM)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesTaiwan
- Study dates
- May 2013to Aug 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
Division of Plastic Surgery, Department of Surgery, China Medical University Hospital
Taichung, 40447
Division of Plastic Surgery, Department of Surgery, China Medical University Beigang Hospital
Yunlin County, 65152
About this study
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 activated-carbon-fiber-based wound dressing on different types of wounds.The dressing is composed by three layers. The first layer is a material of polyethylene terephthalate (PET) weave which is great breathable; Second layer, the activated carbon fiber cloth, is as the absorption of excess tissue fluid, bacteria and contaminations. It reduces the smell of wound and restrains the development of bacteria. In addition, activated carbon has features of far-infrared and anion, which promote blood circulation, speed up metabolism and shorten the time of wound healing. The third layer is a polyethlene (PE) film, which touches the wound surface and provides the anti-adhesion effects.
The aim of this study is to investigate how the application of the dressing affects the wound healing conditions on four different types of wounds, including general traumatic wounds, elective surgery wound, diabetes foot ulcer (level 2) and chronic wounds. Due to the characteristics of great fluid absorption and far-infrared features, the hydrophilic-based dressing (KoCarbonTM) is expected to work perfectly on improving the wound repair conditions.
- Conditions
- Wounds
- Being tested
- hydrophilic-based dressing (KoCarbonTM)
- Keywords
- wound healing, carbon
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hydrophilic-based dressing (KoCarbonTM)Device
Also called "BCT" hydrophilic wound dressing
"BCT" Hydrophilic Wound Dressing consists of PET non-woven, activated carbon fiber (ACF) cloth and PE film. The PET non-woven is vapor permeable to allow air exchange for the wound. The absorbent ACF absorbs exudate, bacteria and odor to create an effective barrier. Furthermore, far infrared ray (FIR) emitted from ACF accelerates blood circulation and metabolism to reduce healing period. The PE film helps to minimize wound trauma at dressing changes.
| Study group | Role | What they receive |
|---|---|---|
| Hydrophilic-based dressing (KoCarbonTM) | Experimental | The wound is first cleansed with normal saline, and then applied with hydrophilic-based dressing (KoCarbonTM) and covered by sterile gauze. The frequency of dressing chang is depend on the amount of exudate. Receives: Device: hydrophilic-based dressing (KoCarbonTM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The healing percentage
Photograph of wounds are taken on each visit 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 Percentage N =[(the initial wound area-wound area measured on Day N)/the initial wound area]x100%. N means the number of days counting from the first day initiating this clinical trial.
Measured: one month
Secondary outcomes (1)
The healing rate
Photograph of wounds are taken on each visit 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 Rate= healed area/the number of healing days (cm2/day)
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2013 (estimated)
- Study startMay 2013
- Primary completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WoundsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bio-medical Carbon Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- China Medical University Hospital
- Responsible party
- Sponsor
- Investigators
- Tzong-Shiun Li, M.D., Ph.D., Principal investigator, Division of Plastic Surgery, Department of Surgery, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01921725
- Sponsor's protocol ID
- DMR101-IRB2-156
- Status last verified
- Aug 2013
- First submitted
- 9 Aug 2013
- Last updated
- 13 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Application and Efficacy Verification of an Innovative Carbon Fiber Dressing
- ClinicalTrials.gov ID
- NCT01921725
- Acronym / sponsor ID
- DMR101-IRB2-156
- Conditions
- Wounds
- Keywords
- wound healing, carbon
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Bio-medical Carbon Technology Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- China Medical University Hospital
- Study start
- May 2013
- Primary completion
- Aug 2013 (actual)
- First posted
- 13 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 activated-carbon-fiber-based wound dressing on different types of wounds.The dressing is composed by three layers. The first layer is a material of polyethylene terephthalate (PET) weave which is great breathable; Second layer, the activated carbon fiber cloth, is as the absorption of excess tissue fluid, bacteria and contaminations. It reduces the smell of wound and restrains the development of bacteria. In addition, activated carbon has features of far-infrared and anion, which promote blood circulation, speed up metabolism and shorten the time of wound healing. The third layer is a polyethlene (PE) film, which touches the wound surface and provides the anti-adhesion effects.
The aim of this study is to investigate how the application of the dressing affects the wound healing conditions on four different types of wounds, including general traumatic wounds, elective surgery wound, diabetes foot ulcer (level 2) and chronic wounds. Due to the characteristics of great fluid absorption and far-infrared features, the hydrophilic-based dressing (KoCarbonTM) is expected to work perfectly on improving the wound repair conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hydrophilic-based dressing (KoCarbonTM) | Experimental | Device: hydrophilic-based dressing (KoCarbonTM)The wound is first cleansed with normal saline, and then applied with hydrophilic-based dressing (KoCarbonTM) and covered by sterile gauze. The frequency of dressing chang is depend on the amount of exudate. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hydrophilic-based dressing (KoCarbonTM)Also: "BCT" hydrophilic wound dressing"BCT" Hydrophilic Wound Dressing consists of PET non-woven, activated carbon fiber (ACF) cloth and PE film. The PET non-woven is vapor permeable to allow air exchange for the wound. The absorbent ACF absorbs exudate, bacteria and odor to create an effective barrier. Furthermore, far infrared ray (FIR) emitted from ACF accelerates blood circulation and metabolism to reduce healing period. The PE film helps to minimize wound trauma at dressing changes. | Device | Hydrophilic-based dressing (KoCarbonTM) |
Primary outcome
The healing percentage
Time frame: one month
Photograph of wounds are taken on each visit 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 Percentage N =[(the initial wound area-wound area measured on Day N)/the initial wound area]x100%. N means the number of days counting from the first day initiating this clinical trial.
1 secondary outcome
The healing rate
Time frame: one month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tzong-Shiun Li, M.D., Ph.D. principal investigator
Division of Plastic Surgery, Department of Surgery, China Medical University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hydrophilic-based dressing (KoCarbonTM) in people with Wounds, run by Bio-medical Carbon Technology Co., Ltd. at 2 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The healing percentage (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2013.