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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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

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
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 23, 2014