Clinical trial NCT00768222: Coated VICRYL* Plus Suture Compared to Chinese Silk in Scheduled Breast Cancer Surgery
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Breast Cancer
Keywords: wound healing
Lead sponsor: Ethicon, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Johnson & Johnson Medical, China
First posted: 2008-10-08
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Mean Score on Cosmetic Outcome Visual Analog Scale (VAS)
timeFrame: 30 days (+/- 5) post-operative
Secondary outcomes:
measure: Mean Cosmetic Outcome Score on Modified Hollander Scale
timeFrame: 12 days
measure: Mean Cosmetic Outcome Score on Modified Hollander Scale
timeFrame: 30 days
measure: Mean Surgical Site Infection Score on Modified ASEPSIS Scale
timeFrame: Day 3
measure: Mean Surgical Site Infection Score on Modified ASEPSIS Scale
timeFrame: Day 5
measure: Mean Surgical Site Infection Score on Modified ASEPSIS Scale
timeFrame: Day 7
measure: Mean Surgical Site Infection Score on Modified ASEPSIS Scale
timeFrame: Day 12
measure: Mean Surgical Site Infection Score on Modified ASEPSIS Scale
timeFrame: Day 30
measure: Mean Surgical Site Infection Score on Modified ASEPSIS Scale
timeFrame: Day 90
Other outcomes:
Locations:
city: Beijing
country: China
facility: Capital Medical Univ. affiliated Hospital
city: Changchun
country: China
facility: Jilin Univ. affiliated Second Hospital
city: Dalian
country: China
facility: Dalian Medical Univ. affiliated first Hospital
city: Guangzhou
country: China
facility: First Affiliated Hospital, Sun Yat-sen Univ.
city: Shanghai
country: China
facility: Fudan Univ. affiliated Zhongshan Hospital
city: Shanghai
country: China
facility: Shanghai Jiao Tong Univ. affiliated Ruijin Hospital
Study officials:
affiliation: Capital Medical University Affiliated Beijing Friendship Hospital
name: Zhongtao ZHANG, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.