A Comparative Efficacy and Safety Study Between BCT Silver Bandage and Aquacel® Ag. Dressing In Obstetrical and Gynecological Post-Op Wound Healing

Bio-medical Carbon Technology Co., Ltd.1 site in 1 country38 target enrollmentJune 2012

ConditionsSurgical Wound

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Surgical Wound
Sponsor: Bio-medical Carbon Technology Co., Ltd.
Enrollment: 38
Locations: 1
Primary Endpoint: Efficacy measurements
Status: Terminated
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 2012

End Date

January 2014

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Bio-medical Carbon Technology Co., Ltd.

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

Efficacy measurements

Time Frame: 42 days after operation

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