Surgical WoundNCT01605968
A Comparative Efficacy and Safety Study Between Two Silver Containing Dressings In Post-Op Wound Healing
A study testing BCT Silver Bandage and Aquacel® Ag. Dressing in people with Surgical Wound, run by Bio-medical Carbon Technology Co., Ltd. at 1 site in Taiwan.
Trial summary
Study objective: The objective of this study is to evaluate through clinical criteria the clinical efficacy and safety of BCT Silver Bandage role in obstetrical and gynecological wound healing is as effective and safe as Aquacel® Ag. Dressing. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Surgical Wound
- What is being tested?
- BCT Silver Bandage and Aquacel® Ag. Dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2012to Jan 2014
- 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 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male/Female of any race aged between 18 - 70 years old
- The subject is willing and able to understand, sign and date the study Informed Consent, and be able to adhere to the scheduled visits regimen.
- The subject is having surgery (Cesarean pfannenstiel or Open Laparotomy incision) within 1 week
Who cannot join
- Patients with known allergy or topical hypersensitivity to ionic silver or alginate
- 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
- Patients undergoing MRI (Magnetic Resonance Imaging) examination.
- Subject residence is outside the study center city
- Patients was participating in another clinical trial less than 30 days before participation in this trial
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Dep. of Gynecology and Obstetrics, Chung-Shan Medical University Hospital
Taichung, 40201
About this study
Official title: A Comparative Efficacy and Safety Study Between BCT Silver Bandage and Aquacel® Ag. Dressing In Obstetrical and Gynecological Post-Op Wound Healing
Study objective:
The objective of this study is to evaluate through clinical criteria the clinical efficacy and safety of BCT Silver Bandage role in obstetrical and gynecological wound healing is as effective and safe as Aquacel® Ag. Dressing.
Read more
Study devices:
- Study device: BCT Silver Bandage
- Comparator device:"ConvaTec"Aquacel® Ag Hydrofiber Dressing
Study design:
- Randomized, Open-label, interventional, comparative, preventive study with Blinded evaluator.
- All subjects must meet all the inclusion \& exclusion criteria to enter this study in pre-operative phase.
- Eligible subjects will be enrolled after a scheduled operative procedure.
- There is SEVEN visits in this study (one screening eligibility phase up to 7 days before OP day, and four post-op treatment scheduled visits consisting on 1st , 3rd day, 5th day, 12th day and two follow up visit on the 28th and the 42nd post-operative day.
- During each scheduled visit, each subject will have colored picture of his wound after dressing been removed, and on visit V6 for wound evaluation by blinded PI.
Number of subjects: It is expected to recruit ≧150 eligible subjects.
Study Duration: About eighteen month.
- Conditions
- Surgical Wound
- Being tested
- BCT Silver Bandage, Aquacel® Ag. Dressing
- Keywords
- Obstetrics, Gynecology, Wound healing
- Medical subject headings
- Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCT Silver BandageDevice
Activated carbon fiber impregnated with silver particles
Aquacel® Ag. DressingDevice
Antimicrobial primary dressing incorporating the unique gelling action of Hydrofiber® Technology with ionic silver for wounds that are infected or at risk of infection.
| Study group | Role | What they receive |
|---|---|---|
| BCT Silver Bandage | Experimental | Not described Receives: Device: BCT Silver Bandage |
| Aquacel® Ag. Dressing | Active comparator | Not described Receives: Device: Aquacel® Ag. Dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy measurements
- Wound infection rate within 5 days after operation
- Wound healing evaluation by Stony Brook Scar Evaluation Scale (SBSES), to be evaluated by blinded PI at V6
- Skin discoloration around the incision wound and/or wound keloid formation rate at V6
- Patient and Observer Scar Assessment Scale (POSAS) on V3, V5 and V6
Measured: 42 days after operation
Secondary outcomes (1)
Safety Measurement
The incidence of postoperative skin reactions (defined as blisters, itching, erythematous change around the surgical wound site) within 5 days after operation
Measured: 42 days after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2012 (estimated)
- Study startJun 2012
- Primary completionOct 2013
- Study completionJan 2014
Why it stopped: The rate of subject recruitment is too slow.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical WoundStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bio-medical Carbon Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Chung Shan Medical University
- Responsible party
- Sponsor
- Investigators
- Chih-Jen Tseng, MD, Principal investigator, Dep. of Gynecology and Obstetrics, Chung-Shan Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01605968
- Sponsor's protocol ID
- CS11176
- Status last verified
- Jul 2017
- First submitted
- 23 May 2012
- Last updated
- 14 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Efficacy and Safety Study Between BCT Silver Bandage and Aquacel® Ag. Dressing In Obstetrical and Gynecological Post-Op Wound Healing
- ClinicalTrials.gov ID
- NCT01605968
- Acronym / sponsor ID
- CS11176
- Conditions
- Surgical Wound
- Keywords
- Obstetrics, Gynecology, Wound healing
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The rate of subject recruitment is too slow.
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Bio-medical Carbon Technology Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Chung Shan Medical University
- Study start
- Jun 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 25 May 2012 (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.
Study objective:
The objective of this study is to evaluate through clinical criteria the clinical efficacy and safety of BCT Silver Bandage role in obstetrical and gynecological wound healing is as effective and safe as Aquacel® Ag. Dressing.
Study devices:
- Study device: BCT Silver Bandage
- Comparator device:"ConvaTec"Aquacel® Ag Hydrofiber Dressing
Study design:
- Randomized, Open-label, interventional, comparative, preventive study with Blinded evaluator.
- All subjects must meet all the inclusion \& exclusion criteria to enter this study in pre-operative phase.
- Eligible subjects will be enrolled after a scheduled operative procedure.
- There is SEVEN visits in this study (one screening eligibility phase up to 7 days before OP day, and four post-op treatment scheduled visits consisting on 1st , 3rd day, 5th day, 12th day and two follow up visit on the 28th and the 42nd post-operative day.
- During each scheduled visit, each subject will have colored picture of his wound after dressing been removed, and on visit V6 for wound evaluation by blinded PI.
Number of subjects: It is expected to recruit ≧150 eligible subjects.
Study Duration: About eighteen month.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BCT Silver Bandage | Experimental | Device: BCT Silver Bandage |
| Aquacel® Ag. Dressing | Active comparator | Device: Aquacel® Ag. Dressing |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male/Female of any race aged between 18 - 70 years old
- The subject is willing and able to understand, sign and date the study Informed Consent, and be able to adhere to the scheduled visits regimen.
- The subject is having surgery (Cesarean pfannenstiel or Open Laparotomy incision) within 1 week
Key exclusion criteria (5 listed)
- Patients with known allergy or topical hypersensitivity to ionic silver or alginate
- 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
- Patients undergoing MRI (Magnetic Resonance Imaging) examination.
- Subject residence is outside the study center city
- Patients was participating in another clinical trial less than 30 days before participation in this trial
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 |
|---|---|---|
| BCT Silver BandageActivated carbon fiber impregnated with silver particles | Device | BCT Silver Bandage |
| Aquacel® Ag. DressingAntimicrobial primary dressing incorporating the unique gelling action of Hydrofiber® Technology with ionic silver for wounds that are infected or at risk of infection. | Device | Aquacel® Ag. Dressing |
Primary outcome
Efficacy measurements
Time frame: 42 days after operation
1. Wound infection rate within 5 days after operation 2. Wound healing evaluation by Stony Brook Scar Evaluation Scale (SBSES), to be evaluated by blinded PI at V6 3. Skin discoloration around the incision wound and/or wound keloid formation rate at V6 4. Patient and Observer Scar Assessment Scale (POSAS) on V3, V5 and V6
1 secondary outcome
Safety Measurement
Time frame: 42 days after operation
Results and safety
The study was stopped early (reason given: The rate of subject recruitment is too slow.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2017.
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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.
Chih-Jen Tseng, MD principal investigator
Dep. of Gynecology and Obstetrics, Chung-Shan Medical University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BCT Silver Bandage and Aquacel® Ag. Dressing in people with Surgical Wound, run by Bio-medical Carbon Technology Co., Ltd. at 1 site 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 3 inclusion and 5 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: stopped early, as of the sponsor's last update on 14 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was stopped early (reason given: The rate of subject recruitment is too slow.). Results are not available in the source record.
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?
Efficacy measurements (time frame: 42 days after operation). 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 14 Jul 2017.