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
1 other identifier
interventional
101
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 breast-cancer
Started Oct 2008
Shorter than P25 for phase_4 breast-cancer
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 7, 2008
CompletedFirst Posted
Study publicly available on registry
October 8, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedResults Posted
Study results publicly available
August 25, 2011
CompletedAugust 31, 2011
August 1, 2011
5 months
October 7, 2008
June 27, 2011
August 29, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (8)
Mean Cosmetic Outcome Score on Modified Hollander Scale
12 days
Mean Cosmetic Outcome Score on Modified Hollander Scale
30 days
Mean Surgical Site Infection Score on Modified ASEPSIS Scale
Day 3
Mean Surgical Site Infection Score on Modified ASEPSIS Scale
Day 5
Mean Surgical Site Infection Score on Modified ASEPSIS Scale
Day 7
- +3 more secondary outcomes
Study Arms (2)
Chinese Silk Suture
ACTIVE COMPARATORNatural, non-absorbable silk suture made from entwined thread from silkworm larva, commercially available in China, used in a simple interrupted transdermal suture pattern
VICRYL* Plus Suture
EXPERIMENTALSynthetic absorbable surgical suture composed of a copolymer of 90% glycolide and 10% L-lactide and containing triclosan antibacterial, used in a subcuticular closure technique
Interventions
skin closure
Eligibility Criteria
You may qualify if:
- 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 qualify 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ethicon, Inc.lead
- Johnson & Johnson Medical, Chinacollaborator
Study Sites (6)
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
Related Publications (1)
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.
PMID: 21518565DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Xiaowei SUN, MD PhD
- Organization
- J&J Medical, China Ltd.
Study Officials
- PRINCIPAL INVESTIGATOR
Zhongtao ZHANG, MD
Capital Medical University Affiliated Beijing Friendship Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 7, 2008
First Posted
October 8, 2008
Study Start
October 1, 2008
Primary Completion
March 1, 2009
Study Completion
May 1, 2009
Last Updated
August 31, 2011
Results First Posted
August 25, 2011
Record last verified: 2011-08