Status:
COMPLETED
Coated VICRYL* Plus Suture Compared to Chinese Silk in Scheduled Breast Cancer Surgery
Lead Sponsor:
Ethicon, Inc.
Collaborating Sponsors:
Johnson & Johnson Medical, China
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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...
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 Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT00768222
Start Date
October 1 2008
End Date
May 1 2009
Last Update
August 31 2011
Active Locations (6)
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1
Capital Medical Univ. affiliated Hospital
Beijing, China
2
Jilin Univ. affiliated Second Hospital
Changchun, China
3
Dalian Medical Univ. affiliated first Hospital
Dalian, China
4
First Affiliated Hospital, Sun Yat-sen Univ.
Guangzhou, China