Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Ethicon, Inc.
With
Johnson & Johnson Medical, China
Patients will be evaluated post-procedure on Days 3, 5, 7, 12, 30 and 90 for cosmetic outcome and surgical site infection.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
