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
Patients will be evaluated post-procedure on Days 3, 5, 7, 12, 30 and 90 for cosmetic
outcome and surgical site infection.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Mean Score on Cosmetic Outcome Visual Analog Scale (VAS)
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
30 days (+/- 5) post-operative
No
Zhongtao ZHANG, MD
Principal Investigator
Capital Medical University Affiliated Beijing Friendship Hospital
China: Food and Drug Administration
200-08-002
NCT00768222
October 2008
May 2009
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