A Comparative Efficacy and Safety Study Between Two Silve... | NCT01605968

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

NCT01605968

Sponsor

Bio-medical Carbon Technology Co., Ltd.

Status

Terminated

Last Update Posted

Jul 14, 2017Actual

Enrollment

38Actual

Phase

Not Applicable

Conditions

Surgical Wound

Interventions

BCT Silver Bandage
Aquacel® Ag. Dressing

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The rate of subject recruitment is too slow.

Expanded Access Info

Start Date

Jun 2012

Primary Completion Date

Oct 2013Actual

Completion Date

Jan 2014Actual

First Submitted Date

May 23, 2012

First Submission Date that Met QC Criteria

May 24, 2012

First Posted Date

May 25, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 12, 2017

Last Update Posted Date

Jul 14, 2017Actual

Name	Class
Chung Shan Medical University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

38Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BCT Silver Bandage	Experimental		Device: BCT Silver Bandage
Aquacel® Ag. Dressing	Active Comparator		Device: Aquacel® Ag. Dressing

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BCT Silver Bandage	Device	Activated carbon fiber impregnated with silver particles	BCT Silver Bandage

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Efficacy measurements	Wound infection rate within 5 days after operation Wound healing evaluation by Stony Brook Scar Evaluation Scale (SBSES), to be evaluated by blinded PI at V6 Skin discoloration around the incision wound and/or wound keloid formation rate at V6 Patient and Observer Scar Assessment Scale (POSAS) on V3, V5 and V6	42 days after operation

Secondary Outcomes

Measure	Description	Time Frame
Safety Measurement	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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Chih-Jen Tseng, MD	Dep. of Gynecology and Obstetrics, Chung-Shan Medical University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dep. of Gynecology and Obstetrics, Chung-Shan Medical University Hospital		Taichung		40201	Taiwan