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

July 12, 2017 updated by: Bio-medical Carbon Technology Co., Ltd.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taichung City, Taiwan, 40201
        • Dep. of Gynecology and Obstetrics, Chung-Shan Medical University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
42 days after operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety Measurement
Time Frame: 42 days after operation
The incidence of postoperative skin reactions (defined as blisters, itching, erythematous change around the surgical wound site) within 5 days after operation
42 days after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bio-medical Carbon Technology Co., Ltd.

Collaborators

Chung Shan Medical University

Investigators

  • Principal Investigator: Chih-Jen Tseng, MD, Dep. of Gynecology and Obstetrics, Chung-Shan Medical University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

May 23, 2012

First Submitted That Met QC Criteria

May 24, 2012

First Posted (Estimate)

May 25, 2012

Study Record Updates

Last Update Posted (Actual)

July 14, 2017

Last Update Submitted That Met QC Criteria

July 12, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CS11176

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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