Coated VICRYL* Plus Suture Compared to Chinese Silk in Scheduled Breast Cancer Surgery
NCT ID: NCT00768222
Last Updated: 2011-08-31
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE4
101 participants
INTERVENTIONAL
2008-10-31
2009-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Chinese Silk Suture
Natural, non-absorbable silk suture made from entwined thread from silkworm larva, commercially available in China, used in a simple interrupted transdermal suture pattern
silk suture
skin closure
VICRYL* Plus Suture
Synthetic absorbable surgical suture composed of a copolymer of 90% glycolide and 10% L-lactide and containing triclosan antibacterial, used in a subcuticular closure technique
VICRYL* Plus suture
skin closure
Interventions
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silk suture
skin closure
VICRYL* Plus suture
skin closure
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Scheduled for a modified radical mastectomy
* Surgical wound classified Class I/Clean using the CDC SSI Surgical Wound Classification
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Johnson & Johnson Medical, China
INDUSTRY
Ethicon, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Zhongtao ZHANG, MD
Role: PRINCIPAL_INVESTIGATOR
Capital Medical University Affiliated Beijing Friendship Hospital
Locations
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Capital Medical Univ. affiliated Hospital
Beijing, , China
Jilin Univ. affiliated Second Hospital
Changchun, , China
Dalian Medical Univ. affiliated first Hospital
Dalian, , China
First Affiliated Hospital, Sun Yat-sen Univ.
Guangzhou, , China
Fudan Univ. affiliated Zhongshan Hospital
Shanghai, , China
Shanghai Jiao Tong Univ. affiliated Ruijin Hospital
Shanghai, , China
Countries
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References
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Zhang ZT, Zhang HW, Fang XD, Wang LM, Li XX, Li YF, Sun XW, Carver J, Simpkins D, Shen J, Weisberg M. Cosmetic outcome and surgical site infection rates of antibacterial absorbable (Polyglactin 910) suture compared to Chinese silk suture in breast cancer surgery: a randomized pilot research. Chin Med J (Engl). 2011 Mar;124(5):719-24.
Other Identifiers
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200-08-002
Identifier Type: -
Identifier Source: org_study_id