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

May 23, 2012
February 12, 2014
June 2012
October 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01605968 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
A Comparative Efficacy and Safety Study Between Two Silver Containing Dressings In Post-Op Wound Healing
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.

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Surgical Wound
  • Device: BCT Silver Bandage
    Activated carbon fiber impregnated with silver particles
  • 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.
  • Experimental: BCT Silver Bandage
    Intervention: Device: BCT Silver Bandage
  • Active Comparator: Aquacel® Ag. Dressing
    Intervention: Device: Aquacel® Ag. Dressing
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
38
Not Provided
October 2013   (final data collection date for primary outcome measure)

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
Female
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT01605968
CS11176
No
Bio-medical Carbon Technology Co., Ltd.
Bio-medical Carbon Technology Co., Ltd.
Chung Shan Medical University
Principal Investigator: Chih-Jen Tseng, MD Dep. of Gynecology and Obstetrics, Chung-Shan Medical University Hospital
Bio-medical Carbon Technology Co., Ltd.
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP