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Coated VICRYL* Plus Suture Compared to Chinese Silk in Scheduled Breast Cancer Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00768222
First Posted: October 8, 2008
Last Update Posted: August 31, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Johnson & Johnson Medical, China
Information provided by (Responsible Party):
Ethicon, Inc.
  Purpose
This is a 90-day study to evaluate cosmetic outcome and Surgical Site Infection in approximately 100 patients from 6 centers in China undergoing scheduled modified radical mastectomy for breast cancer.

Condition Intervention Phase
Breast Cancer Device: silk suture Device: VICRYL* Plus suture Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Evaluation of Cosmetic Outcome and Surgical Site Infection Rates of Coated VICRYL* Plus Antibacterial (Polyglactin 910) Suture Compared to Chinese Silk in Scheduled Breast Cancer Surgery

Resource links provided by NLM:


Further study details as provided by Ethicon, Inc.:

Primary Outcome Measures:
  • Mean Score on Cosmetic Outcome Visual Analog Scale (VAS) [ Time Frame: 30 days (+/- 5) post-operative ]
    Post-operative cosmetic outcome assessed on surgical site photographs by an independent blinded central assessor using a validated 100 mm visual analog scale, with 0 representing the worst possible scar and 100 representing the best possible scar


Secondary Outcome Measures:
  • Mean Cosmetic Outcome Score on Modified Hollander Scale [ Time Frame: 12 days ]
    Post-operative cosmetic outcome assessed on surgical site by investigator using the modified Hollander Cosmetic Scale (mHCS) with 0 representing worst and 6 representing best, calculated by adding the individual scores on each of 6 categories (step-off borders, contour irregularities, wound margin separation, edge inversion, excessive inflammation, and overall appearance

  • Mean Cosmetic Outcome Score on Modified Hollander Scale [ Time Frame: 30 days ]
    Post-operative cosmetic outcome assessed on surgical site by investigator using the modified Hollander Cosmetic Scale (mHCS) with 0 representing worst and 6 representing best, calculated by adding the individual scores on each of 6 categories (step-off borders, contour irregularities, wound margin separation, edge inversion, excessive inflammation, and overall appearance

  • Mean Surgical Site Infection Score on Modified ASEPSIS Scale [ Time Frame: Day 3 ]
    Post-operative assessment of wound by trained observer to identify SSI based on several characteristics that are assigned points that contribute to a total score, with 0-10 representing satisfactory healing (best), 11-20 representing disturbance of healing, 21-30 representing minor wound infection, 31-40 representing moderate wound infection, and over 40 representing severe wound infection (worst)

  • Mean Surgical Site Infection Score on Modified ASEPSIS Scale [ Time Frame: Day 5 ]
    Post-operative assessment of wound by trained observer to identify SSI based on several characteristics that are assigned points that contribute to a total score, with 0-10 representing satisfactory healing (best), 11-20 representing disturbance of healing, 21-30 representing minor wound infection, 31-40 representing moderate wound infection, and over 40 representing severe wound infection (worst)

  • Mean Surgical Site Infection Score on Modified ASEPSIS Scale [ Time Frame: Day 7 ]
    Post-operative assessment of wound by trained observer to identify SSI based on several characteristics that are assigned points that contribute to a total score, with 0-10 representing satisfactory healing (best), 11-20 representing disturbance of healing, 21-30 representing minor wound infection, 31-40 representing moderate wound infection, and over 40 representing severe wound infection (worst)

  • Mean Surgical Site Infection Score on Modified ASEPSIS Scale [ Time Frame: Day 12 ]
    Post-operative assessment of wound by trained observer to identify SSI based on several characteristics that are assigned points that contribute to a total score, with 0-10 representing satisfactory healing (best), 11-20 representing disturbance of healing, 21-30 representing minor wound infection, 31-40 representing moderate wound infection, and over 40 representing severe wound infection (worst)

  • Mean Surgical Site Infection Score on Modified ASEPSIS Scale [ Time Frame: Day 30 ]
    Post-operative assessment of wound by trained observer to identify SSI based on several characteristics that are assigned points that contribute to a total score, with 0-10 representing satisfactory healing (best), 11-20 representing disturbance of healing, 21-30 representing minor wound infection, 31-40 representing moderate wound infection, and over 40 representing severe wound infection (worst)

  • Mean Surgical Site Infection Score on Modified ASEPSIS Scale [ Time Frame: Day 90 ]
    Post-operative assessment of wound by trained observer to identify SSI based on several characteristics that are assigned points that contribute to a total score, with 0-10 representing satisfactory healing (best), 11-20 representing disturbance of healing, 21-30 representing minor wound infection, 31-40 representing moderate wound infection, and over 40 representing severe wound infection (worst)


Enrollment: 101
Study Start Date: October 2008
Study Completion Date: May 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Chinese Silk Suture
Natural, non-absorbable silk suture made from entwined thread from silkworm larva, commercially available in China, used in a simple interrupted transdermal suture pattern
Device: silk suture
skin closure
Other Name: surgical suture (silk)
Experimental: VICRYL* Plus Suture
Synthetic absorbable surgical suture composed of a copolymer of 90% glycolide and 10% L-lactide and containing triclosan antibacterial, used in a subcuticular closure technique
Device: VICRYL* Plus suture
skin closure
Other Names:
  • Polyglactin 910 (Vicryl)
  • Triclosan (antibacterial)

Detailed Description:
Patients will be evaluated post-procedure on Days 3, 5, 7, 12, 30 and 90 for cosmetic outcome and surgical site infection.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years of age or older with written informed consent
  • Scheduled for a modified radical mastectomy
  • Surgical wound classified Class I/Clean using the CDC SSI Surgical Wound Classification

Exclusion Criteria:

  • Unable to give consent and unlikely to comply with study requirements and complete the 90-day follow up visit
  • Undergoing surgery for modified radical mastectomy with immediate breast reconstruction, cosmetic breast operations, reduction, expansion, insertion of prothesis, duct ectasia or infective breast disease or implant
  • Surgical wounds classified as Class II, III or IV using CDC SSI Surgical Wound Classification
  • Has inflammatory cancers or skin ulceration
  • Has known allergy or intolerance to triclosan
  • Has compromised wound healing or chronic immune deficiency, for example diabetes, prolonged steroid use, AIDS or substance abuse
  • Has serious heart and/or lung disease
  • Has skin scar history or family history
  • Has direct relationship to or involvement in this or other studies under the direction of the investigator or center
  • Received an experimental drug or device within 30 days prior to the planned start of treatment
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00768222


Locations
China
Capital Medical Univ. affiliated Hospital
Beijing, China
Jilin Univ. affiliated Second Hospital
Changchun, China
Dalian Medical Univ. affiliated first Hospital
Dalian, China
First Affiliated Hospital, Sun Yat-sen Univ.
Guangzhou, China
Fudan Univ. affiliated Zhongshan Hospital
Shanghai, China
Shanghai Jiao Tong Univ. affiliated Ruijin Hospital
Shanghai, China
Sponsors and Collaborators
Ethicon, Inc.
Johnson & Johnson Medical, China
Investigators
Principal Investigator: Zhongtao ZHANG, MD Capital Medical University Affiliated Beijing Friendship Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ethicon, Inc.
ClinicalTrials.gov Identifier: NCT00768222     History of Changes
Other Study ID Numbers: 200-08-002
First Submitted: October 7, 2008
First Posted: October 8, 2008
Results First Submitted: June 27, 2011
Results First Posted: August 25, 2011
Last Update Posted: August 31, 2011
Last Verified: August 2011

Keywords provided by Ethicon, Inc.:
wound healing

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Anti-Bacterial Agents
Triclosan
Anti-Infective Agents
Anti-Infective Agents, Local
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents