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

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

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.

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

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