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

NCT ID: NCT01605968

Last Updated: 2017-07-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2014-01-31

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

BCT Silver Bandage

Group Type: EXPERIMENTAL

BCT Silver Bandage

Intervention Type: DEVICE

Activated carbon fiber impregnated with silver particles

Aquacel® Ag. Dressing

Group Type: ACTIVE_COMPARATOR

Aquacel® Ag. Dressing

Intervention Type: DEVICE

Antimicrobial primary dressing incorporating the unique gelling action of Hydrofiber® Technology with ionic silver for wounds that are infected or at risk of infection.

Interventions

BCT Silver Bandage

Activated carbon fiber impregnated with silver particles

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Chung Shan Medical University

OTHER

Sponsor Role: collaborator

Bio-medical Carbon Technology Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chih-Jen Tseng, MD

Role: PRINCIPAL_INVESTIGATOR

Dep. of Gynecology and Obstetrics, Chung-Shan Medical University Hospital

Locations

Dep. of Gynecology and Obstetrics, Chung-Shan Medical University Hospital

Taichung, , Taiwan

Countries

Taiwan

Other Identifiers

CS11176

Identifier Type: -

Identifier Source: org_study_id