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

Bio-medical Carbon Technology

Status

Terminated

Conditions

Surgical Wound

Treatments

Device: BCT Silver Bandage

Device: Aquacel® Ag. Dressing

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01605968

CS11176

Details and patient eligibility

About

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.

Enrollment

38 patients

Sex

Female

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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