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A Comparative Efficacy and Safety Study Between Two Silver Containing Dressings In Post-Op Wound Healing

This study has been terminated.
Sponsor:
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: February 12, 2014
Last verified: February 2014
  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 ]
    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


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


Enrollment: 38
Study Start Date: June 2012
Primary Completion Date: October 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01605968

Locations
Taiwan
Dep. of Gynecology and Obstetrics, Chung-Shan Medical University Hospital
Taichung City, Taiwan, 40201
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: February 12, 2014
Health Authority: Taiwan: Department of Health

Keywords provided by Bio-medical Carbon Technology Co., Ltd.:
Obstetrics
Gynecology
Wound healing

ClinicalTrials.gov processed this record on November 27, 2014