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

This study has been completed.
Sponsor:
Collaborator:
Johnson & Johnson Medical, China
Information provided by (Responsible Party):
Ethicon, Inc.
ClinicalTrials.gov Identifier:
NCT00768222
First received: October 7, 2008
Last updated: August 29, 2011
Last verified: August 2011
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Shanghai Jiao Tong Univ. affiliated Ruijin Hospital
Shanghai, China
Fudan Univ. affiliated Zhongshan 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

No publications provided by Ethicon, Inc.

Additional 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
Study First Received: October 7, 2008
Results First Received: June 27, 2011
Last Updated: August 29, 2011
Health Authority: China: Food and Drug Administration

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
Therapeutic Uses
Pharmacologic Actions
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Local
Lipid Regulating Agents

ClinicalTrials.gov processed this record on April 17, 2014