Skip to main content
OpenTrials
Completed

NCT Number: NCT00768222

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Capital Medical Univ. affiliated Hospital, Beijing, China

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

silk suture

Device

skin closure

Other names: surgical suture (silk)

VICRYL* Plus suture

Device

skin closure

Other names: Polyglactin 910 (Vicryl), Triclosan (antibacterial)

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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)

Sponsors and collaborators

Lead sponsor

Ethicon, Inc.

Industry

Collaborators

  • Johnson & Johnson Medical, China

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Oct 8, 2008
Registry last updated
Aug 31, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.