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

NCT01605968 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2017-07-14

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Chung Shan Medical University

    collaborator OTHER

  • Bio-medical Carbon Technology Co., Ltd.

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2013-10-31
Completion
2014-01-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01605968 on ClinicalTrials.gov