A Comparative Efficacy and Safety Study Between Two Silver Containing Dressings In Post-Op Wound Healing
This study is currently recruiting participants.
Verified June 2013 by Bio-medical Carbon Technology Co., Ltd.
Sponsor:
Bio-medical Carbon Technology Co., Ltd.
Collaborator:
Chung Shan Medical University
Information provided by (Responsible Party):
Bio-medical Carbon Technology Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01605968
First received: May 23, 2012
Last updated: June 3, 2013
Last verified: June 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Surgical Wound |
Device: BCT Silver Bandage Device: Aquacel® Ag. Dressing |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Comparative Efficacy and Safety Study Between BCT Silver Bandage and Aquacel® Ag. Dressing In Obstetrical and Gynecological Post-Op Wound Healing |
Further study details as provided by Bio-medical Carbon Technology Co., Ltd.:
Primary Outcome Measures:
- Efficacy measurements [ Time Frame: 42 days after operation ] [ Designated as safety issue: No ]
- 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
Secondary Outcome Measures:
- Safety Measurement [ Time Frame: 42 days after operation ] [ Designated as safety issue: Yes ]The incidence of postoperative skin reactions (defined as blisters, itching, erythematous change around the surgical wound site) within 5 days after operation
| Estimated Enrollment: | 150 |
| Study Start Date: | June 2012 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: BCT Silver Bandage |
Device: BCT Silver Bandage
Activated carbon fiber impregnated with silver particles
|
| Active Comparator: Aquacel® Ag. Dressing |
Device: Aquacel® Ag. Dressing
Antimicrobial primary dressing incorporating the unique gelling action of Hydrofiber® Technology with ionic silver for wounds that are infected or at risk of infection.
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01605968
Contacts
| Contact: Yu-Chih Chen, PhD | +886-4-23554588 ext 710 | iqwone.chen@bm-carbon.com |
| Contact: Dai-Jen Lee, PhD | +886-4-23554588 ext 704 | stacey.lee@bm-carbon.com |
Locations
| Taiwan | |
| Dep. of Gynecology and Obstetrics, Chung-Shan Medical University Hospital | Recruiting |
| Taichung City, Taiwan, 40201 | |
| Contact: Chih-Jen Tseng, MD + 886-4-24739595 ext 34501 tsengcj@gmail.com | |
Sponsors and Collaborators
Bio-medical Carbon Technology Co., Ltd.
Chung Shan Medical University
Investigators
| Principal Investigator: | Chih-Jen Tseng, MD | Dep. of Gynecology and Obstetrics, Chung-Shan Medical University Hospital |
More Information
No publications provided
| Responsible Party: | Bio-medical Carbon Technology Co., Ltd. |
| ClinicalTrials.gov Identifier: | NCT01605968 History of Changes |
| Other Study ID Numbers: | CS11176 |
| Study First Received: | May 23, 2012 |
| Last Updated: | June 3, 2013 |
| Health Authority: | Taiwan: Department of Health |
Keywords provided by Bio-medical Carbon Technology Co., Ltd.:
|
Obstetrics Gynecology Wound healing |
Additional relevant MeSH terms:
|
Carboxymethylcellulose Sodium Laxatives Gastrointestinal Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 17, 2013