NCT01605968

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2012

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 25, 2012

Completed
7 days until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

July 14, 2017

Status Verified

July 1, 2017

Enrollment Period

1.3 years

First QC Date

May 23, 2012

Last Update Submit

July 12, 2017

Conditions

Surgical Wound

Keywords

ObstetricsGynecologyWound healing

Outcome Measures

Primary Outcomes (1)

  • Efficacy measurements

    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 Outcomes (1)

  • Safety Measurement

    42 days after operation

Study Arms (2)

BCT Silver Bandage

EXPERIMENTAL
Device: BCT Silver Bandage

Aquacel® Ag. Dressing

ACTIVE COMPARATOR
Device: Aquacel® Ag. Dressing

Interventions

BCT Silver BandageDEVICE

Activated carbon fiber impregnated with silver particles

BCT Silver Bandage
Aquacel® Ag. DressingDEVICE

Antimicrobial primary dressing incorporating the unique gelling action of Hydrofiber® Technology with ionic silver for wounds that are infected or at risk of infection.

Aquacel® Ag. Dressing

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dep. of Gynecology and Obstetrics, Chung-Shan Medical University Hospital

Taichung, 40201, Taiwan

Location

MeSH Terms

Conditions

Surgical Wound

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Chih-Jen Tseng, MD

    Dep. of Gynecology and Obstetrics, Chung-Shan Medical University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2012

First Posted

May 25, 2012

Study Start

June 1, 2012

Primary Completion

October 1, 2013

Study Completion

January 1, 2014

Last Updated

July 14, 2017

Record last verified: 2017-07

Locations

TW(1)